Subject observations

Abstract

A system, including: a memory, wherein the memory stores measurements or changes thereof of a physiological parameter measured during a session of a treatment and / or following the treatment session, wherein the measurements indicate a response or changes thereof of the subject body to a sensory interface presented to the subject during the treatment session; a user interface configured to generate and deliver a human detectable indication; a control circuitry configured to: process the measurements to determine performance of the subject in the treatment session; produce a suggestion indication according to the determined performance, wherein the suggestion indication comprises information about one or more ways to maintain or improve performance of the subject in an additional session of the treatment compared to the determined performance in the treatment session; signal the user interface to generate and deliver a human detectable indication with the suggestion indication.

Description

[0001] SUBJECT OBSERVATIONS

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 63 / 738,548 filed December 24, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to generating observations about a subject undergoing training, and, more particularly, but not exclusively, to generating observations about a subject undergoing biofeedback training.

[0006] SUMMARY OF THE INVENTION

[0007] Some examples of some embodiments of the invention are listed below (it should be noted that one or more features of an example may be used in combination with one or more features of another example):

[0008] Example 1. A method, comprising:

[0009] measuring at least one signal indicating activity of at least one brain target during at least one session of a NF treatment in which a subject is instructed to modify a sensory interface presented to the subject, wherein changes in said sensory interface indicate changes in activity of the at least one brain target;

[0010] processing said at least one signal;

[0011] determining performance of said subject during said at least one session based on said processing results;

[0012] generating based on said determined performance, at least one observation indication with information about performance of said subject in said at least one session and / or with information about performance of the subject in at least one additional NF session;

[0013] producing according to said generated at least one observation indication, at least one suggestion indication with information about one or more ways to improve or to maintain performance of said subject in said at least one additional NF treatment session.

[0014] Example 2. A method according to example 1, wherein said generating comprises generating based on said determined performance, at least one treatment-related observation indication with information about an interaction between the subject and the NF treatment, and wherein saidproducing comprises producing at least one suggestion indication with information about one or more ways to improve interaction between the subject and the NF treatment.

[0015] Example 3. A method according to example 2, wherein said at least one treatment-related observation comprises information that the subject has applied a mental strategy in order to modify the sensory interface that was not optimal, and wherein said suggestion comprises a suggestion for the subject to modify said mental strategy or to replace said mental strategy with a different mental strategy.

[0016] Example 4. A method according to any one of examples 2 or 3, wherein said at least one treatment-related observation comprises information that the subject did not follow instructions of said NF treatment, and wherein said suggestion comprises a suggestion to modify said instructions and / or to repeat delivery of said instructions, before and / or during, said at least one session, or said at least one additional NF session.

[0017] Example 5. A method according to any one of the previous examples, wherein said at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0018] Example 6. The method of any one of the previous examples, wherein said at least one suggestion indication comprises at least one of, a suggestion to modify the NF treatment or at least one parameter of the NF treatment, a suggestion to have at least one psychotherapy session or at least one cognitive behavioral treatment (CBT) session with the subject, a suggestion of at least one topic for a discussion with the subject, a suggestion to modify at least one parameter of said treatment, and / or a suggestion to combine said treatment with at least one additional treatment. Example 7. The method of any one of the previous examples, wherein said processing comprises identifying in said at least one signal one or more epochs in which the signal indicates a target change in activity of said at least one brain target relative to a reference activity level, measuring one or more parameters of said at least one signal during said one or more epochs, and calculating an activity score of said at least one brain target based on said measurements, wherein said determining performance comprises determining performance of said subject by determining a relation between said calculated activity score and a reference value indicating target activity of said at least one brain target, and wherein said generating at least one observation comprises generating said at least one observation based on said determined relation.Example 8. The method of any one of the previous examples, wherein said generating at least one observation comprises selecting said at least one observation indication from a group of predetermined observations based on said determined performance.

[0019] Example 9. The method of any one of the previous examples, wherein said producing said at least one suggestion indication comprises selecting said at least one suggestion indication from a group of predetermined suggestions.

[0020] Example 10. The method of any one of the previous examples, wherein said generating comprises generating said at least one observation using at least one large language model (LLM) based on said determined performance.

[0021] Example 11. The method of any one of the previous examples, wherein said producing comprises producing said at least one suggestion indication using at least one large language model (LLM), according to said generated at least one observation indication.

[0022] Example 12. The method of any one of the previous examples, comprising delivering said produced at least one suggestion indication to a healthcare provider (HCP) monitoring said treatment, prior to at least one additional treatment session of said NF and / or in a beginning of said at least one additional treatment session.

[0023] Example 13. The method of example 12, wherein said at least one suggestion indication comprises at least one of, a suggestion to modify the treatment or at least one parameter of the at least one additional treatment session, a suggestion to have at least one psychotherapy session or at least one cognitive behavioral treatment (CBT) session with the subject, a suggestion of at least one topic for a discussion with the subject, a suggestion to modify at least one parameter of said treatment, and / or a suggestion to combine said treatment with at least one additional treatment. Example 14. The method of any one of examples 1 to 11, comprising delivering said produced at least one suggestion indication to the subject, prior to at least one additional NF treatment session and / or in a beginning of said at least one additional treatment session, and wherein said at least one suggestion indication comprises a suggestion for the subject to perform at least one mental or cognitive task.

[0024] Example 15. The method of any one of examples 12 to 14, comprising receiving a feedback signal from said healthcare provider and / or from said subject with information about said delivered suggestion following said delivering.

[0025] Example 16. The method of any one of the previous examples, comprising:

[0026] receiving signals recorded from a brain of said subject by at least one electrode;wherein said measuring comprises measuring at least one EEG signal indicating activity of said at least one brain target by processing said received signals using at least one model correlating EEG signals with activity of said at least one brain target.

[0027] Example 17. The method of any one of the previous examples, wherein said subject is diagnosed with at least one mental disorder or suffers from at least one symptom of said mental disorder. Example 18. The method of example 17, wherein said mental disorder comprises at least one of, a stress disorder, post-traumatic stress disorder (PTSD), Attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD), depression and / or major depressive disorder (MDD).

[0028] Example 19. The method of any one of the previous examples, wherein said method is performed by a system.

[0029] Example 20. A method, comprising:

[0030] receiving measurements of at least one physiological parameter, wherein said measurements indicate a response or changes thereof of the subject body during at least one session of a treatment in which the subject is presented with at least one sensory interface;

[0031] processing the measurements to determine performance of said subject in said treatment; generating at least one observation indication regarding performance of said subject in said at least one session of said treatment and / or regarding performance of said subject in at least one additional session of said treatment, wherein said at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0032] Example 21. The method of example 20, wherein said generating said at least one observation indication comprises selecting said at least one observation indication from a group of predetermined observation indications using at least one of, a lookup table, an algorithm, a mathematical model, and / or a formula correlating a determined performance with at least one observation indication from said group of predetermined observation indications.

[0033] Example 22. The method of any one of examples 20 or 21, wherein said determining comprises determining that said performance is lower relative to a target performance, and wherein said generated at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined lower performance.

[0034] Example 23. The method of example 22, comprising producing at least one suggestion indication with information about one or more ways to improve or maintain performance of said subject in atleast one additional session of said treatment, according to said generated at least one observation indication.

[0035] Example 24. The method of example 23, wherein said at least one suggestion indication comprises at least one of, a suggestion to modify the treatment or at least one parameter of the at least one additional session, a suggestion to have at least one psychotherapy session or at least one cognitive behavioral treatment (CBT) session with the subject, a suggestion of at least one topic for a discussion with the subject, a suggestion to modify at least one parameter of said treatment, and / or a suggestion to combine said treatment with at least one additional treatment.

[0036] Example 25. The method of any one of examples 23 or 24, comprising:

[0037] delivering said at least one suggestion indication to a healthcare provider (HCP) monitoring said treatment, prior to at least one additional treatment session of said treatment and / or in a beginning of said at least one additional treatment session.

[0038] Example 26. The method of example 23, wherein said at least one suggestion indication comprises a suggestion for the subject to perform at least one mental or cognitive task, and wherein said method comprises delivering said at least one suggestion indication to said subject prior to at least one additional treatment session of said treatment and / or in a beginning of said at least one additional treatment session.

[0039] Example 27. The method of example 23, wherein said at least one suggestion indication comprises a suggestion to administer at least one drug to the subject prior to at least one additional treatment session of said treatment and / or during the at least one additional treatment session, and wherein said method comprises delivering said at least one suggestion indication to the HCP and / or to the subject.

[0040] Example 28. The method of any one of examples 25 to 27, comprising receiving a feedback signal from said HCP and / or from said subject with information about said delivered suggestion following said delivering.

[0041] Example 29. The method of any one of examples 23 to 28, wherein said producing comprises selecting said at least one suggestion indication from a group of predetermined suggestion indications according to said generated at least one observation indication.

[0042] Example 30. The method of example 29, wherein said selecting comprises selecting said at least one suggestion indication from said group of predetermined suggestion indications using at least one of, a lookup table, an algorithm, a mathematical model, and / or a formula correlating at least one observation indication with at least one suggestion indication from said group of predetermined suggestion indications.Example 31. The method of any one of the previous examples, wherein said subject is diagnosed with at least one mental disorder or suffers from at least one symptom of said mental disorder.

[0043] Example 32. The method of example 31, wherein said mental disorder comprises at least one of, a stress disorder, post-traumatic stress disorder (PTSD), Attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD), depression and / or major depressive disorder (MDD).

[0044] Example 33. The method of any one of examples 20 to 32, wherein said treatment comprises biofeedback treatment in which said subject is trained to modify at least one physiological response of a body, wherein said at least one physiological parameter comprises at least one of, heart rate, heart rate variability, blood pressure, muscle tension, skin temperature, skin conductance, oxygen saturation, breathing rate, respiratory effort, peripheral temperature, cerebral blood flow, and / or pupil dilation and constriction, and wherein said sensory interface comprises a sensory indication indicating changes in said measurements of said at least one physiological parameter.

[0045] Example 34. The method of any one of examples 20 to 32, wherein said treatment comprises a neurofeedback treatment in which said subject is trained to modify activity of at least one brain target, wherein said measurements are measurements of EEG signals indicating activity of the at least one brain target, and wherein changes in said sensory interface indicate activity of the at least one brain target or changes thereof.

[0046] Example 35. The method of example 34, wherein said at least one brain target comprises at least one of, at least one brain region, at least one sub-cortical brain region, at least one brain network, an amygdala brain region, at least one brain network including the amygdala brain region, a salience network, a reward system and / or at least one brain region of the reward system.

[0047] Example 36. The method of any one of examples 20 to 35, wherein said method is performed by a system.

[0048] Example 37. A method, comprising:

[0049] receiving measurements of at least one physiological parameter, wherein said measurements indicate a response or changes thereof of the subject body during at least one session of a treatment in which the subject is presented with at least one sensory interface;

[0050] processing the measurements to predict performance of said subject in at least one additional session of said treatment;

[0051] producing at least one suggestion indication with information about one or more ways to increase or maintain performance of said subject in the at least one additional session based on the predicted performance.

[0052] Example 38. The method of example 37, wherein said processing comprises identifying in said measurements one or more epochs in which the changes in said measurements of said at least onephysiological parameter during said one or more epochs indicate performance of said subject which is higher than a reference value, calculating values of one or more parameters of said changes in said measurements during said one or more epochs, and predicting said performance in said at least one additional session based on said calculated values.

[0053] Example 39. The method of example 38, wherein said at least one physiological parameter comprises activity of at least one brain target, and wherein said measurements comprises measurements of at least one EEG signal.

[0054] Example 40. The method of example 39, wherein said at least one brain target comprises at least one of, at least one brain region, at least one sub-cortical brain region, at least one brain network, an amygdala brain region, at least one brain network including the amygdala brain region, a salience network, a reward system and / or at least one brain region of the reward system.

[0055] Example 41. The method of any one of examples 39 or 40, wherein said calculating comprises calculating values of one or more parameters used in a prediction model, wherein said prediction model comprises said one or more parameters and weights of said one or more parameters and wherein said predicting comprises predicting said performance in said at least one additional session using said prediction model.

[0056] Example 42. The method of any one of examples 37 to 41, wherein said predicting comprises calculating a predicted performance score indicating performance of said subject in said at least one treatment session, and wherein said producing comprises producing said at least one suggestion based on said calculated predicted performance score.

[0057] Example 43. The method of example 42, wherein said producing comprises selecting said at least one suggestion from a group of predetermined suggestions according to said predicted performance score.

[0058] Example 44. The method of any one of examples 37 to 43, wherein said at least one suggestion indication comprises at least one of, a suggestion to modify the treatment or at least one parameter of the at least one additional session, a suggestion to have at least one psychotherapy session or at least one cognitive behavioral treatment (CBT) session with the subject, a suggestion of at least one topic for a discussion with the subject, and / or a suggestion to combine said treatment with at least one additional treatment.

[0059] Example 45. The method of example 44, wherein said at least one additional treatment comprises a drug treatment.

[0060] Example 46. The method of any one of examples 37 to 45, comprising delivering said at least one suggestion indication to a HCP and / or to the subject prior to the at least one additional session or in a beginning of the at least one additional session.Example 47. The method of any one of examples 37 to 46, wherein said method is performed by a system.

[0061] Example 48. A system, comprising:

[0062] a memory, wherein said memory stores measurements of at least one physiological parameter, wherein said measurements indicate a response or changes thereof of the subject body during at least one session of a treatment in which the subject is presented with at least one sensory interface, and information about said treatment;

[0063] a user interface configured to generate and deliver at least one human detectable indication;

[0064] a control circuitry, wherein said control circuitry is configures to:

[0065] process said measurements to determine performance of said subject in said treatment, wherein said determine performance comprises determine performance in said at least one treatment session and / or determining performance in at least one additional session of said treatment;

[0066] produce at least one suggestion indication according to said determined performance, wherein said at least one suggestion indication comprises information about one or more ways to maintain or improve performance of said subject in at least one additional session of said treatment;

[0067] signal said user interface to generate and deliver at least one human detectable indication with said at least one suggestion indication, prior to said at least one additional session or in a beginning of said at least one additional session, based on said treatment information stored in said memory. Example 49. A system according to example 48, wherein said memory stores a group of predetermined suggestion indications, and wherein said control circuitry is configured to produce said at least one suggestion indication by selecting said at least one suggestion indication from said group of predetermined suggestion indications stored in said memory according to said determined performance.

[0068] Example 50. A system according to example 49, wherein said memory stores at least one lookup table, algorithm or formula correlating performance of said subject and at least one suggestion indication of said group of predetermined suggestion indications, and wherein said control circuitry produces said at least one suggestion indication using said at least one lookup table, said algorithm or said formula.

[0069] Example 51. A system according to any one of examples 48 to 50, wherein said memory stores at least one large language model (LLM), and wherein said control circuitry produces said at least one suggestion indication using said at least one LLM model.

[0070] Example 52. A system according to any one of examples 48 to 51, wherein said control circuitry is configured to generate at least one observation indication with information about performance of said subject in said at least one session and / or with information about predicted performance of thesubject in at least one additional NF session, based on said determined performance of said subject, and to produce said at least one suggestion indication based on said generated at least one observation indication.

[0071] Example 53. A system according to example 52, wherein said memory stores a group of predetermined observation indications, and wherein said control circuitry is configured to generate said at least one observation indication by selecting said at least one observation indication from said group of said predetermined observation indications stored in said memory based on said determined performance of said subject.

[0072] Example 54. A system according to example 53, wherein said memory stores at least one lookup table, algorithm or formula correlating determined performance of said subject with at least one observation indication, and wherein said control circuitry is configured to select said at least one observation indication using said at least one lookup table, algorithm or formula.

[0073] Example 55. A system according to example 53, wherein said memory stores at least one large language model (LLM), and wherein said control circuitry generates said at least one observation indication using said at least one LLM model.

[0074] Example 56. A system according to any one of examples 52 to 55, wherein said at least one observation indication generated by said control circuitry comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0075] Example 57. A system according to example 56, wherein said control circuitry is configured to determine that said performance is lower than a target performance, and to generate said at least one observation indication with information about at least one biopsychosocial factor associated with said determined lower performance.

[0076] Example 58. A system according to any one of examples 48 to 57, wherein said measurements comprise measurements indicating activity of at least one brain target during said at least one treatment session, wherein said control circuitry is configured to process said measurements by dividing said measurements into epochs in which said activity is lower or higher that a reference value, and to determine said performance of said subject based on at least one parameter of said measurements during said epochs.

[0077] Example 59. A system according to example 58 wherein said treatment comprises a neurofeedback (NF) treatment in which said subject is trained to modify activity of said at least onebrain target, wherein said measurements comprise measurements of EEG signals indicating activity of the at least one brain target.

[0078] Example 60. A system according to example 59, wherein said treatment comprises a NF treatment in which said subject is trained to downregulate activity of said at least one brain target, and wherein said control circuitry is configured to process said measurements to determine performance of said subject in said at least one treatment session by determining an ability of said subject to downregulate activity of said at least one brain target below a predetermined reference value stored in said memory, and to calculate a performance score based on said determined ability, and wherein said control circuitry is configured to produce said at least one suggestion based on said calculated performance score.

[0079] Example 61. A system according to example 59, wherein said treatment comprises a NF treatment in which said subject is trained to upregulate activity of said at least one brain target, and wherein said control circuitry is configured to process said measurements to determine performance of said subject in said at least one treatment session by determining an ability of said subject to upregulate activity of said at least one brain target above a predetermined reference value stored in said memory and to calculate a performance score based on said determined ability, and wherein said control circuitry is configured to produce said at least one suggestion based on said calculated performance score.

[0080] Example 62. A system according to any one of examples 59 to 61, wherein said at least one brain target comprises at least one of, at least one brain region, at least one sub-cortical brain region, at least one brain network, an amygdala brain region, at least one brain network including the amygdala brain region, a salience network, a reward system and / or at least one brain region of the reward system.

[0081] Example 63. A system according to any one of examples 59 to 62, wherein said at least one suggestion indication comprises at least one of, a suggestion to modify the treatment or at least one parameter of the at least one additional session, a suggestion to have at least one psychotherapy session or at least one cognitive behavioral treatment (CBT) session with the subject, a suggestion of at least one topic for a discussion with the subject, a suggestion to modify at least one parameter of said treatment, and / or a suggestion to combine said treatment with at least one additional treatment.

[0082] Example 64. A system according to any one of examples 59 to 63, wherein said memory stores at least one protocol of said NF treatment, and wherein said system is used to deliver said NF treatment to said subject according to said at least one protocol stored in said memory.Additional examples of some embodiments of the invention are listed below (it should be noted that one or more features of an example may be used in combination with one or more features of another example):

[0083] Example 1. A system, comprising:

[0084] a memory, wherein the memory stores measurements or changes thereof of at least one physiological parameter measured during at least one session of a treatment and / or following the at least one treatment session, wherein the measurements indicate a response or changes thereof of the subject body to at least one sensory interface presented to the subject during the at least one treatment session;

[0085] a user interface configured to generate and deliver at least one human detectable indication;

[0086] a control circuitry, wherein the control circuitry is configured to:

[0087] process the measurements to determine performance of the subject in the at least one treatment session;

[0088] produce at least one suggestion indication according to the determined performance, wherein the at least one suggestion indication comprises information about one or more ways to maintain or improve performance of the subject in at least one additional session of the treatment compared to the determined performance in the at least one treatment session;

[0089] signal the user interface to generate and deliver at least one human detectable indication with the at least one suggestion indication.

[0090] Example 2. A system according to example 1, wherein the memory stores a group of predetermined suggestion indications, and wherein the control circuitry is configured to produce the at least one suggestion indication by selecting the at least one suggestion indication from the group of predetermined suggestion indications stored in the memory according to the determined performance.

[0091] Example 3. A system according to example 2, wherein the memory stores at least one lookup table, algorithm or formula correlating performance of the subject and at least one suggestion indication of the group of predetermined suggestion indications, and wherein the control circuitry produces the at least one suggestion indication using the at least one lookup table, the algorithm or the formula.

[0092] Example 4. A system according to any one of the previous examples, wherein the memory stores at least one large language model (LLM), and wherein the control circuitry produces the at least one suggestion indication using the at least one LLM model.

[0093] Example 5. A system according to any one of the previous examples, wherein the control circuitry is configured to generate at least one observation indication with information aboutperformance of the subject in the at least one session and / or with information about predicted performance of the subject in at least one additional NF session, based on the determined performance of the subject, and to produce the at least one suggestion indication based on the generated at least one observation indication.

[0094] Example 6. A system according to example 5, wherein the memory stores a group of predetermined observation indications, and wherein the control circuitry is configured to generate the at least one observation indication by selecting the at least one observation indication from the group of the predetermined observation indications stored in the memory based on the determined performance of the subject.

[0095] Example 7. A system according to example 6, wherein the memory stores at least one lookup table, algorithm or formula correlating determined performance of the subject with at least one observation indication, and wherein the control circuitry is configured to select the at least one observation indication using the at least one lookup table, algorithm or formula.

[0096] Example 8. A system according to example 6, wherein the memory stores at least one large language model (LLM), and wherein the control circuitry generates the at least one observation indication using the at least one LLM model.

[0097] Example 9. A system according to any one of examples 5 to 8, wherein the at least one observation indication generated by the control circuitry comprises information about at least one biopsychosocial factor associated with the determined performance of the subject or with predicted performance of the subject in at least one additional session of the treatment, wherein the at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0098] Example 10. A system according to example 9, wherein the control circuitry is configured to determine that the performance is lower than a target performance, and to generate the at least one observation indication with information about at least one biopsychosocial factor associated with the determined lower performance.

[0099] Example 11. A system according to any one of the previous examples, wherein the measurements comprise measurements of signals from a brain of the subject indicating activity of at least one brain target during the at least one treatment session.

[0100] Example 12. A system according to example 11, wherein the at least one brain target comprises at least one of, at least one brain region, at least one sub-cortical brain region, at least one brain network, an amygdala brain region, at least one brain network including the amygdala brain region, a salience network, a reward system and / or at least one brain region of the reward system.Example 13. A system according to any one of examples 11 or 12, wherein the control circuitry is configured to process the measurements by dividing the measurements into epochs in which the activity is lower or higher that a reference value, and to determine the performance of the subject based on at least one parameter of the measurements during the epochs.

[0101] Example 14. A system according to any one of examples 11 to 13, wherein the treatment comprises a neurofeedback (NF) treatment in which the subject is trained to modify activity of the at least one brain target, wherein the measurements comprise measurements of signals from a subject brain indicating activity of the at least one brain target.

[0102] Example 15. A system according to example 14, wherein the signals comprise electroencephalogram (EEG) signals.

[0103] Example 16. A system according to any one of examples 14 or 15, wherein during the NF treatment the subject is trained to modulate activity of the at least one brain target in a target direction by performing at least one cognitive task during the at least one treatment session, and wherein the control circuitry is configured to process the measurements to determine performance of the subject in the at least one treatment session by determining an ability of the subject to modulate the activity of the at least one brain target in the target direction by performing the at least one cognitive task;

[0104] wherein the control circuitry is configured to calculate a performance score based on the determined ability, and wherein the control circuitry is configured to produce the at least one suggestion based on the calculated performance score.

[0105] Example 17. A system according to example 16, wherein the control circuitry produces the at least one suggestion indication with a suggestion to modify the at least one cognitive task performed by the subject or to perform a different cognitive task, if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

[0106] Example 18. A system according to any one of examples 16 or 17, wherein the memory stores information about the at least one cognitive task performed by the subject.

[0107] Example 19. A system according to any one of examples 16 to 18, wherein the control circuitry produces the at least one suggestion indication with a suggestion to stop or modify the NF treatment if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

[0108] Example 20. A system according to any one of examples 16 to 19, wherein the control circuitry produces the at least one suggestion indication with a suggestion to replace or combine the NF treatment with at least one additional treatment if the calculated performance score indicates thatthe performance of the subject during the at least one treatment session was lower than a target performance level.

[0109] Example 21. A system according to example 20, wherein the at least one additional treatment comprises at least one of, psychotherapy, cognitive behavioral treatment (CBT) and at least one drug treatment.

[0110] Example 22. A system according to any one of examples 14 to 21, wherein the memory stores at least one protocol of the NF treatment, and wherein the system is used to deliver the NF treatment to the subject according to the at least one protocol stored in the memory.

[0111] Example 23. A method, comprising:

[0112] measuring at least one signal indicating activity of at least one brain target during at least one session of a neurofeedback (NF) treatment in which a subject is instructed to modify a sensory interface presented to the subject towards a target sensory interface by performing at least one cognitive task, wherein changes in the sensory interface indicate changes in activity of the at least one brain target;

[0113] processing the at least one signal;

[0114] determining performance of the subject during the at least one session based on the processing results;

[0115] generating based on the determined performance, at least one observation indication with information about performance of the subject in the at least one session and / or with information about expected performance of the subject in at least one additional NF session;

[0116] producing according to the generated at least one observation indication, at least one suggestion indication with information about one or more ways to improve or to maintain performance of the subject in the at least one additional NF treatment session.

[0117] Example 24. A method according to example 23, wherein the generating comprises generating based on the determined performance, at least one treatment-related observation indication with information about an interaction between the subject and the NF treatment, and wherein the producing comprises producing at least one suggestion indication with information about one or more ways to improve interaction between the subject and the NF treatment.

[0118] Example 25. A method according to example 24, wherein the at least one treatment-related observation comprises information that the subject did not follow instructions of the NF treatment, and wherein the suggestion comprises a suggestion to modify the instructions and / or to repeat delivery of the instructions, before and / or during, the at least one session, or the at least one additional NF session.Example 26. A method according to any one of examples 24 or 25, wherein the at least one observation indication comprises information that the subject has performed a sub-optimal cognitive task during the at least one NF treatment session, and wherein the at least one suggestion indication comprises a suggestion to modify the cognitive task, or to replace the cognitive task with a different cognitive task.

[0119] Example 27. A method according to any one of examples 23 to 26, wherein the at least one observation indication comprises information that the subject performance during the at least one NF treatment session was sub-optimal, and wherein the at least one suggestion indication comprises a suggestion to stop or modify the NF treatment.

[0120] Example 28. A method according to any one of examples 23 to 27, wherein the at least one observation indication comprises information that the subject performance during the at least one NF treatment session was sub-optimal, and wherein the at least one suggestion indication comprises a suggestion to replace or to combine the NF treatment with at least one different treatment.

[0121] Example 29. A method according to example 28, wherein the at least one different treatment comprises at least one of, a drug treatment, psychotherapy, and cognitive behavioral treatment (CBT).

[0122] Example 30. A method according to any one of examples 23 to 26, wherein the at least one observation indication comprises information about at least one biopsychosocial factor associated with the determined performance of the subject or with predicted performance of the subject in at least one additional session of the treatment, wherein the at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0123] Example 31. The method of any one of examples 23 to 30, wherein the processing comprises identifying in the at least one signal one or more epochs in which the signal indicates a target change in activity of the at least one brain target relative to a reference activity level, measuring one or more parameters of the at least one signal during the one or more epochs, and calculating an activity score of the at least one brain target based on the measurements, wherein the determining performance comprises determining performance of the subject by determining a relation between the calculated activity score and a reference value indicating target activity of the at least one brain target, and wherein the generating at least one observation comprises generating the at least one observation based on the determined relation.

[0124] Example 32. The method of any one of examples 23 to 31, wherein the generating at least one observation comprises selecting the at least one observation indication from a group of predetermined observations based on the determined performance.Example 33. The method of any one of examples 23 to 32, wherein the producing the at least one suggestion indication comprises selecting the at least one suggestion indication from a group of predetermined suggestions.

[0125] Example 34. The method of any one of examples 23 to 33, wherein the generating comprises generating the at least one observation using at least one large language model (LLM) based on the determined performance, and / or wherein the producing comprises producing the at least one suggestion indication using at least one large language model (LLM), according to the generated at least one observation indication.

[0126] Example 35. The method of any one of examples 23 to 34, comprising delivering the produced at least one suggestion indication to a healthcare provider (HCP) monitoring the treatment and / or to the subject, prior to at least one additional treatment session of the NF and / or in a beginning of the at least one additional treatment session.

[0127] Example 36. The method of example 35, comprising receiving a feedback signal from the healthcare provider and / or from the subject with information about the delivered suggestion following the delivering, and generating at least one different suggestion indication based on the feedback information.

[0128] Example 37. The method of any one of examples 23 to 36, comprising:

[0129] receiving signals recorded from a brain of the subject by at least one electrode;

[0130] wherein the measuring comprises measuring at least one EEG signal indicating activity of the at least one brain target by processing the received signals using at least one model correlating EEG signals with activity of the at least one brain target.

[0131] Example 38. The method of any one of examples 23 to 37, wherein the subject is diagnosed with at least one mental disorder or suffers from at least one symptom of the mental disorder.

[0132] Example 39. The method of example 38, wherein the at least one mental disorder comprises post-traumatic stress disorder (PTSD).

[0133] Example 40. The method of any one of examples 38 or 39, wherein the at least one mental disorder comprises at least one of, attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD), depression and / or major depressive disorder (MDD).

[0134] Example 41. A method, comprising:

[0135] receiving measurements of at least one physiological parameter, wherein the measurements indicate a response or changes thereof of the subject body during at least one session of a treatment in which the subject is presented with at least one sensory interface;

[0136] processing the measurements to determine performance of the subject in the treatment;generating at least one observation indication regarding performance of the subject in the at least one session of the treatment and / or regarding performance of the subject in at least one additional session of the treatment, wherein the at least one observation indication comprises information about at least one biopsychosocial factor associated with the determined performance of the subject or with predicted performance of the subject in at least one additional session of the treatment, wherein the at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

[0137] Example 42. The method of example 41, wherein the generating the at least one observation indication comprises selecting the at least one observation indication from a group of predetermined observation indications using at least one of, a lookup table, an algorithm, a mathematical model, and / or a formula correlating a determined performance with at least one observation indication from the group of predetermined observation indications.

[0138] Example 43. The method of any one of examples 41 or 42, wherein the determining comprises determining that the performance is lower relative to a target performance, and wherein the generated at least one observation indication comprises information about at least one biopsychosocial factor associated with the determined lower performance.

[0139] Example 44. The method of example 43, comprising producing at least one suggestion indication with information about one or more ways to improve or maintain performance of the subject in at least one additional session of the treatment, according to the generated at least one observation indication.

[0140] Example 45. The method of example 44, comprising:

[0141] delivering the at least one suggestion indication to a healthcare provider (HCP) monitoring the treatment prior to at least one additional treatment session of the treatment and / or in a beginning of the at least one additional treatment session.

[0142] Example 46. The method of example 45, wherein the at least one suggestion indication comprises a suggestion of at least one topic for a discussion with the subject.

[0143] Example 47. The method of any one of examples 45 or 46, wherein the at least one suggestion indication comprises a suggestion to replace the treatment or to combine the treatment with at least one additional treatment, wherein the at least one additional treatment comprises at least one of, a drug treatment, a neurofeedback treatment, psychotherapy and cognitive behavioral treatment (CBT).

[0144] Example 48. The method of any one of examples 45 to 47, wherein the at least one suggestion indication comprises a suggestion for the subject to perform at least one cognitive task prior to or during at least one additional session of the treatment.Example 49. The method of any one of examples 45 to 48, wherein the at least one suggestion indication comprises a suggestion to administer at least one drug to the subject prior to at least one additional treatment session of the treatment and / or during the at least one additional treatment session.

[0145] Example 50. The method of any one of examples 45 to 49, comprising receiving a feedback signal from the HCP and / or from the subject with feedback information about the delivered suggestion following the delivering, and generating at least one different suggestion indication based on the feedback information.

[0146] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0147] As will be appreciated by one skilled in the art, some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the invention can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and / or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and / or by a combination thereof, e.g., using an operating system.

[0148] For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and / or system as described herein are performed by a data processor, such as a computing platform for executing aplurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is provided as well. A display and / or a user input device such as a keyboard or mouse are optionally provided as well.

[0149] Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0150] A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0151] Program code embodied on a computer readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0152] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on aremote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0153] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0154] These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function / act specified in the flowchart and / or block diagram block or blocks.

[0155] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0156] Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as generating a score for determining activity of at least one brain region or a network of brain regions, might be expected to use completely different methods, e.g., making use of expert knowledge and / or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0157] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0158] In the drawings:

[0159] FIG. 1A is a flow chart of a general process for generating an observation about performance of a subject in a treatment and delivering a a suggestion, according to some exemplary embodiments of the invention;

[0160] FIG. IB is a schematic illustration showing delivering of suggestions based on measurements and / or input received before, during and / or following a treatment, for example biofeedback treatment, according to some exemplary embodiments of the invention;

[0161] FIG. 1C is a schematic illustration showing a synergistic effect of a biofeedback treatment and a therapy meeting when used together to provide a personalized treatment to a subject, according to some exemplary embodiments of the invention;

[0162] FIG. ID is a flow chart of a general process for determining subject performance in a biofeedback procedure, according to some exemplary embodiments of the invention;

[0163] FIGs. 2A and 2B are block diagram of systems for generating observations regarding subject performance and / or for producing suggestions for maintaining or improving subject performance, according to some exemplary embodiments of the invention;

[0164] FIG. 3 is a flow chart of a process for determining success of a subject in a treatment, according to some exemplary embodiments of the invention;

[0165] FIG. 4A is a flow chart of a process for determining success of a subject, for example a trainee, in a neurofeedback (NF) process, according to some exemplary embodiments of the invention;

[0166] FIG. 4B is a flow chart of a process in which a supervisor of a treatment, for example a NF process, receives at least one indication regarding performance of a subject in a treatment, according to some exemplary embodiments of the invention;

[0167] FIG. 4C is a flow chart of a process for generating observations and suggestions, based on ability of the subject to self-modify brain activity, for example brain activity of at least one brain target, in a desired direction (up or down) relative to baseline brain activity, according to some exemplary embodiments of the invention;FIG. 4D is a flow chart of a process for generating observations about a subject, for example observations about a subject state and / or performance during a neurofeedback process and for providing indications based on the observations, according to some exemplary embodiments of the invention;

[0168] FIG. 4E is a flow chart of a process performed by a system, for providing of a biofeedback procedure to a subject and delivering suggestions for at least one discussion with the subject, according to some exemplary embodiments of the invention;

[0169] FIG. 4F is a flow chart of a process performed by a health care professional for receiving suggestions for discussion ideas from a system and using the suggested discussion ideas during a meeting with a subject, for example a patient, according to some exemplary embodiments of the invention;

[0170] FIGs. 5A-5F are graphs showing activity of at least one brain region or at least one brain network during a neurofeedback treatment and different ways for calculating a score indicating a success of a subject in modulating an activity of the at least one brain region or the at least one brain network in a desired, for example target direction, according to some exemplary embodiments of the invention;

[0171] FIG. 5G is a flow chart of a process for predicting subject performance in a future NF session, and generating observation and / or suggestion according to the prediction, according to some exemplary embodiments of the invention;

[0172] FIG. 5H is a flow chart of a process for applying a prediction model to predict performance of a subject in future NF sessions, according to some exemplary embodiments of the invention;

[0173] FIG. 6 is a scheme of a NF treatment, according to some exemplary embodiments of the invention;

[0174] FIG. 7A is a schematic illustration showing a process for determining activity of a specific brain region, for example an Amygdala, based on electroencephalogram (EEG) recordings, according to some exemplary embodiments of the invention;

[0175] FIG. 7B is a schematic illustration showing a NF process, according to some exemplary embodiments of the invention;

[0176] FIG. 8 is a table, for example a lookup table, showing a possible relation between performance of a subject or changes thereof during a NF process, and one or more related observations about interaction of the subject with the NF process and / or the subject emotional state during the NF process, according to some exemplary embodiments of the invention;

[0177] FIG. 9A is a graph showing progress of a subject in a NF treatment, according to some exemplary embodiments of the invention; andFIG. 9B is a is a graph showing overall quality of the way by which a subject modulated a brain target activity indication, for example a biomarker of the brain target activity, according to some exemplary embodiments of the invention.

[0178] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0179] The present invention, in some embodiments thereof, relates to generating observations about a subject undergoing training, and, more particularly, but not exclusively, to generating observations about a subject undergoing biofeedback training.

[0180] Overview

[0181] A broad aspect of some embodiments relates to generating at least one observation, for example an observation indication, about a subject performing at least one session of a procedure, for example a treatment, based on performance of the subject during the at least one session. In some embodiments, the treatment comprises biofeedback treatment, for example neurofeedback. Alternatively, the treatment comprises psychotherapy, cognitive behavioral therapy (CBT), or any type of therapy or training in which measurements of body activity before, during and / or after a session of the treatment can be used by a system to assess performance of a subject in the treatment. In some embodiments, the measurements and / or the assessed performance are then used by the system to generate at least one observations about the subject performance, state and / or experience, and produce at least one suggestion with information about one or more ways for maintaining or improving subject performance and / or experience in one or more following sessions of the treatment.

[0182] According to some embodiments, the at least one observation is about at least one biopsychosocial factor affecting subject performance and / or experience of the subject in the treatment. Alternatively or additionally, the at least one observation is about at least one biopsychosocial factor that may affect performance and / or experience of the subject in at least one additional treatment session. Alternatively or additionally, the at least one observation comprises a prediction regarding performance and / or experience of the subject in at least one additional treatment session. In some embodiments, an observation about subject experience, comprises an observation about subject interaction with a system used for delivery of the treatment and / or with a protocol or instructions of the treatment.

[0183] According to some exemplary embodiments, determining subject performance comprises determining an ability of the subject to reach a target goal of a procedure, or an ability of the subject to reach a target modulation of a biological response, for example a target modulation of abiomarker indicating body activity, indicating brain activity, and / or indicating activity of at least one brain target.

[0184] According to some embodiments, during the procedure, for example during the treatment, the subject is requested to apply a mental strategy. In some embodiments, applying a mental strategy comprises performing a mental activity, optionally a cognitive task. In some embodiments, a mental strategy comprises at least one of, a positive memory, optionally a personal positive memory, an emotion and / or an experience, that helps the subject to feel at least one of, calm, safe, good, and satisfied. Additionally or alternatively, a mental strategy comprises a memory of things the subject look forward to doing, or used to look forward to doing.

[0185] According to some embodiments, observations regarding subject performance and / or regarding subject experience are generated by a system. For example, observations regarding subject experience comprise observation regarding understanding instructions, selection of an optimal / suboptimal mental strategy, etc.

[0186] In some embodiments, the at least one observation pertains to a biofeedback session that ended or to one or more upcoming biofeedback sessions. In some embodiments, the at least one observation is generated by a system, for example a computerized system which includes at least one control circuitry.

[0187] An aspect of some embodiments relates to generating one or more observations about at least one biopsychosocial factor affecting or predicted to affect performance and / or experience of a subject in a biofeedback treatment. In some embodiments, the one or more observations are generated based on measurements taken from the subject during at least one session of the biofeedback treatment. In some embodiments, the measurements indicate an ability of the subject to modulate at least one physiological response or at least one physiological parameter in a target desired direction, for example to upregulate the at least one physiological response or to downregulate the at least one physiological response or parameter. In some embodiments, the one or more observations is generated by a system.

[0188] According to some embodiments, the at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor. In some embodiments, the at least one physiological response or parameter comprise at least one of, muscle contraction, brain activity, heart rate, heart rate variability, skin temperature, temperature, skin conductance, sweat gland activity, breathing rate, breathing patterns, blood flow, blood flow pulse (BVP), blood pressure, electrical activity of the heart, voice tone, pitch, and speech patterns, body alignment and pressure distribution, blood oxygen saturation and / or Pupil size and responsiveness. In some embodiments, during the biofeedback treatment, the at least one physiological response orparameter thereof, is measured and a feedback signal delivered to the subject is changed continuously or intermittently according to the measurements.

[0189] According to some embodiments, at least one suggestion is generated and optionally delivered to a healthcare professional (HCP) based on the one or more generated observations. Alternatively or additionally, the at least one suggestion is generated and optionally delivered to the subject undergoing the biofeedback treatment. In some embodiments, a HCP comprises at least one of, a doctor, a specialist, an expert, a physician, a psychologist, and / or a psychiatrist. In some embodiments, the at least one suggestion comprises at least one suggested topic for discussion between the subject and the HCP and / or information about the discussion, for example discussion timing, discussion topics, discussion length and / or discussion location.

[0190] According to some embodiments, the at least one suggestion includes information on how to improve success of the subject in one or more additional biofeedback treatment sessions, optionally information on how to reduce a negative effect of the at least one biopsychosocial factor on performance, on experience, and / or success of the subject in the biofeedback treatment. Alternatively or additionally, the suggestion includes information on how to increase, improve or elevate subject experience, for example information on how to increase subject interaction with the system or with a protocol. Optionally, the at least one suggestion is delivered to the subject and / or to the HCP during a treatment session, for example during a biofeedback treatment session to improve performance and / or experience of the subject in the biofeedback treatment session or in a future biofeedback treatment session.

[0191] According to some embodiments, the biofeedback treatment comprises neurofeedback treatment. In some embodiments, the biofeedback treatment and the neurofeedback are delivered to the subject as a training program aiming to teach the subject how to self-modulate a body response in a target direction, for example upregulate or downregulate the body response according to the aims of the training.

[0192] An aspect of some embodiments relates to generating one or more observations based on performance of a subject in at least one biofeedback session. In some embodiments, the observations include a prediction about performance and / or experience of the subject in at least one consecutive biofeedback session. In some embodiments, the one or more observations are generated based on measurements taken from the subject during at least one session of the biofeedback treatment. In some embodiments, the measurements indicate an ability of the subject to modulate at least one physiological response or at least one physiological parameter in a target desired direction, for example to upregulate the at least one physiological response or todownregulate the at least one physiological response or parameter. In some embodiments, the one or more observations is generated by a system.

[0193] According to some embodiments, the at least one physiological response or parameter comprise at least one of, muscle contraction, brain activity, heart rate, heart rate variability, skin temperature, temperature, skin conductance, sweat gland activity, breathing rate, breathing patterns, blood flow, blood flow pulse, blood pressure, electrical activity of the heart, voice tone, pitch, and speech patterns, body alignment and pressure distribution, blood oxygen saturation and / or Pupil size and responsiveness. In some embodiments, during the biofeedback treatment, the at least one physiological response or parameter thereof, is measured and a feedback signal delivered to the subject is changed continuously or intermittently according to the measurements.

[0194] According to some embodiments, at least one suggestion is generated and optionally delivered to the healthcare professional (HCP) based on the one or more generated observations. Alternatively or additionally, the at least one suggestion is generated and optionally delivered to the subject undergoing the biofeedback treatment. In some embodiments, the at least one suggestion comprises at least one suggested topic for discussion between the subject and the HCP and / or information about the discussion, for example discussion timing, discussion topics, discussion length and / or discussion location.

[0195] According to some embodiments, the at least one suggestion includes information on how to improve success and / or experience of the subject in the one or more consecutive biofeedback treatment sessions. Optionally, the at least one suggestion is delivered to the subject and / or to the HCP during a biofeedback treatment session to improve performance and / or experience of the subject in the biofeedback treatment session or in the one or more consecutive biofeedback treatment session.

[0196] According to some embodiments, the biofeedback treatment comprises neurofeedback treatment. In some embodiments, the biofeedback treatment and the neurofeedback are delivered to the subject as a training program aiming to teach the subject how to self-modulate a body response in a target direction, for example upregulate or downregulate the body response according to the aims of the training.

[0197] A potential advantage of the generated suggestion with information about a discussion between the HCP and the subject may be to allow strengthening an emotional linkage between the subject and the HCP, may be to allow strengthening confidence of the subject in the biofeedback treatment and / or in the HCP, and / or may allow improving subject success in one or more additional sessions of the biofeedback treatment.An aspect of some embodiments relates to producing at least one suggestion for maintaining or improving performance and / or experience of a subject in a future session of a treatment, for example a biofeedback treatment, based on input regarding performance of the subject in a previous session of the treatment. In some embodiments, the received input includes information about performance of the subject in the biofeedback treatment, for example measurements taken during the biofeedback treatment. In some embodiments, the suggestions are produced based on a predicted ability of the subject to reach one or more goals of the biofeedback treatment, and / or an ability of the subject to perform the biofeedback treatment and / or to reach a target improvement in the biofeedback treatment in at least one additional session. Alternatively or additionally, the suggestions are produced based on a state of the subject, for example mental state, cognitive state, and / or functional state of the subject during and / or following the biofeedback device. In some embodiments, the at least one suggestion is produced by a control circuitry of a system.

[0198] In some embodiments, the biofeedback treatment comprises a neurofeedback treatment in which the subject is trained to modulate, for example self-modulate activity of at least one brain target. In some embodiments, the neurofeedback treatment is a neurofeedback training.

[0199] In some embodiments, the at least one suggestion is produced and delivered to the HCP in order to improve the likelihood of the patient succeed or to improve success in one or more following sessions and / or to strengthen a bond, for example interaction between the HCP and the subject.

[0200] Without being bound by any theory, strengthening a bond between the HCP and the subject is important in order to improve a state of the subject, for example a mental state, a cognitive state and / or a functional state of the subject.

[0201] According to some embodiments, the input about the subject comprises measurements performed before, during and / or following the biofeedback treatment. In some embodiments, the measurements indicate activity of at least tissue, organ, and / or system of the subject body. In some embodiments, the measurements comprise measurements of at least one physiological parameter, for example heart rate, heart rate variability, blood pressure, muscle movement, and / or skin conductance.

[0202] According to some embodiments, for example in case the biofeedback treatment comprises a neurofeedback treatment, the measurements comprise measurements of at least one signal indicating brain activity. In some embodiments, brain activity comprises activity of at least one brain region, for example a cortical brain region and / or a subcortical brain region. Alternatively or additionally, brain activity comprises activity of a network of brain regions. In some embodiments,the at least one signal comprises an electroencephalogram (EEG) signal, measured using at least one electrode coupled to a subject head during the neurofeedback treatment.

[0203] Alternatively or in addition to measurements, the input about the subject comprises input received from the HCP or an expert or the patient, following examination, for example observation of the subject. In some embodiments, the input received from the HCP or from the expert comprise input about the subject state. In some embodiments, the at least one suggestion is generated by a system receiving the input, for example the measurements and / or input from the HCP, and produces the at least one suggestion based on the received input and using one or more algorithms, look up tables, and programs installed in a memory of the system.

[0204] An aspect of some embodiments relates to determining involvement, for example engagement of a subject with a biofeedback procedure, for example a neurofeedback procedure, and performing actions to induce engagement of the subject with the biofeedback procedure, for example to maintain or increase subject engagement with the biofeedback procedure. In some embodiments, the involvement of the subject is quantitatively determined by calculating a score indicating a degree of the subject involvement. In some embodiments, the score is calculated based on at least one of, signals recorded from the subject brain indicating brain activity, changes in at least one feedback signal delivered to the subject during the training, and measurements of at least one physiological parameter.

[0205] According to some embodiments, a biofeedback procedure, for example a biofeedback therapy requires active involvement of a subject receiving the treatment, in performing mental or cognitive activities to continuously modify a feedback signal. In some embodiments, a subject diagnosed with a mental disorder receiving the biofeedback treatment may have difficulties to be sufficiently involved with the treatment to reach a target goal indicating success of the treatment. In some embodiments, the difficulties may be related to the subject mental state, to the subject behavioral state, and / or to the subject cognitive state.

[0206] A potential advantage of determining involvement of the subject with a biofeedback therapy may be to guide a supervisor of the therapy to perform actions that increase the subject involvement, if the determined involvement is not sufficient.

[0207] According to some exemplary embodiments, a subject as described herein is a subject diagnosed with or suffers from at least one symptom of a mental disorder. Optionally, the biofeedback procedure is used to train the subject to cope, for example deal successfully, with one or more symptoms of the mental disorder. In some embodiments, the mental disorder comprises at least one of, a stress disorder, depression, major depressive disorder (MDD), post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD),or any other mental disorder as described in the Diagnostic and Statistical Manual of Mental Disorders fifth edition or higher.

[0208] A potential advantage of a system that quantifies subject performance during treatment sessions, such as training, lies in its ability to provide observations on a patient’s state, performance, interaction, and experience with the treatment, and / or about the biopsychosocial factors influencing their progress, based on quantitative measurements. By offering detailed observations and data-driven insights, such a system can highlight areas for improvement and provide tailored suggestions to enhance subject performance and success in following sessions of the treatment.

[0209] A potential advantage of such a system may be allowing more informed decision-making, improve treatment customization, and optionally lead to a more effective and measurable patient care outcomes.

[0210] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0211] Exemplary general process for generating observations about a subject

[0212] According to some exemplary embodiments, one or more observations are generated, optionally by a system or a device, about a subject undergoing a treatment, for example a training procedure. In some embodiments, the subject is diagnosed with a mental disorder or suffers from at least one symptom of the mental disorder. In some embodiments, the treatment, for example training is delivered to the subject to help the subject attenuate the effect of the mental disorder or the at least one symptom thereof on the subject daily activities.

[0213] According to some exemplary embodiments, the one or more observations are generated based on measurements performed during at least one treatment session, when the subject optionally reacts to at least one stimulus. In some embodiments, the stimulus is a transient stimulus presented to the subject for less than 30 seconds, for example for less than 10 seconds, for less than 5 seconds, or any intermediate, shorter or longer time period. Alternatively, the stimulus is presented to the subject for more than 5 seconds, for more than 10 seconds, for more than 20 seconds, for more than 30 seconds, or any intermediate, shorter or longer time duration. In some embodiments, the stimulus is static, comprising for example an image. Alternatively, or additionally, the stimulus is dynamic and changes during the presentation delivery, comprising for example a movie. Optionally, the stimulus is modified while being presented according to the measurements or changes thereof.According to some exemplary embodiments, the one or more observations include information about a subject state, for example about at least one biopsychosocial factor associated with the subject state, for example cognitive, behavioral and / or mental state during the treatment session. Alternatively or additionally, the information is about at least one biopsychosocial factor affecting or suspected to affect subject behavior or subject performance and / or experience during the treatment session. Alternatively or additionally, the one or more observations comprise a prediction about performance and / or experience of the subject in at least one additional session, for example in a following session, of the treatment or about performance and / or experience of the subject in at least one different treatment.

[0214] According to some exemplary embodiments, the system generates one or more suggestions based on the one or more generated observations. In some embodiments, the suggestions include information for improving subject performance and / or experience, optionally for increasing subject success, in at least one additional treatment session of the same treatment, or in a different treatment.

[0215] According to some exemplary embodiments, the system generates one or more suggestions for an interaction between a subject and a HCP, for example a therapist, a psychiatrist, and a psychologists, based on measurements indicating activity of the subject body. In some embodiments, the measurements are performed during a treatment given to the subject, for example a biofeedback treatment. Additionally or optionally, the measurements are performed prior to the treatment, for example to establish a reference, optionally a baseline to body activity prior to the treatment. Additionally or optionally, the measurements are performed after the treatment, for example after completing at least one session of the treatment or between two treatment sessions, for example to determine an effect of the treatment on the subject.

[0216] According to some exemplary embodiments, the subject is diagnosed with a disorder, for example a mental disorder, a cognitive disorder or a functional disorder. Alternatively or additionally, the subject suffers from at least one symptom of the disorder. In some embodiments, the disorder comprises a stress disorder, for example PTSD.

[0217] According to some exemplary embodiments, the one or more suggestions generated by the system are suggestions how to set or modify at least one parameter of an interaction, for example a meeting, optionally a therapy meeting, between the HCP and the subject. In some embodiments, the one or more suggestions are generated or selected by the system to strengthen a bond between the HCP, by at least one of, enhancing trust, enhancing safety, generating a more effective communication, and / or enhancing rapport building. In some embodiments, the one or more suggestions are to be provided to the patient by the system or by the provider in order to increasethe likelihood of the patient to have better performance, increase patient success and / or increase patient experience, in one or more of the next sessions.

[0218] A potential advantage of the system is that it may allow to generate insights, for example observations, about the subject by monitoring at least one parameter of the subject body activity during the treatment, for example the biofeedback treatment. In some embodiments, the insights include insights about the subject ability to interact with a treatment interface and / or treatment protocol, to reach a desired goal of the treatment, and / or insights about the performance of the subject during the treatment, and / or insights about the subject experience, for example about subject interaction with the system and / or a protocol optionally delivered by the system. Alternatively or additionally, the insights comprise insights about the subject state, for example mental state, cognitive state and / or functional state. In some embodiments, a functional state comprises an awareness state of the subject, a responsiveness of the subject and / or a motoric state of the subject.

[0219] Reference is now made to fig. 1A, depicting a general process for generating one or more observations and producing at least one suggestion, according to some exemplary embodiments of the invention.

[0220] According to some exemplary embodiments, one or more observations and optionally at least one suggestion, optionally a suggestion indication, is produced by a system based on input delivered to the system. In some embodiments the system is a system that delivers a treatment, for example a treatment in which the subject responds to a sensory interface. In some embodiments, the treatment comprises an interactive treatment in which the subject interacts with at least one of, a HCP, a different human subject, an audio and / or a visual interface, an avatar and / or a graphical user interface. In some embodiments, the interactive treatment comprises a treatment in which the subject interacts with a dynamic interface, for example a dynamic interface that changes in response to changes in the subject or changes caused by the subject. In some embodiments, the treatment comprises a biofeedback treatment. Alternatively, the system that generates the observation and / or produces the suggestion indication is different from the system that delivers the biofeedback treatment to the subject.

[0221] According to some exemplary embodiments, a system receives measurements from a subject performing a treatment, for example an interactive treatment, at block 101. In some embodiments, the measurements are measured during the treatment. Additionally or optionally, the system receives measurements measured prior to the treatment, for example to establish a reference or a baseline to other measurements. Additionally or optionally, the system receives measurements measured following the treatment, for example to determine an effect of the treatment on the subject after completing the treatment or at least one session of the treatment.According to some exemplary embodiments, the measurements indicate an activity of the subject body, for example an activity of at least one system, of at least one organ, and / or of at least one pathway involving two or more organs of the subject body. In some embodiments, the measurements indicate an activity of at least one brain region or activity of a network of two or more brain regions. In some embodiments, the measurements are measurements of at least one physiological parameter, for example heart rate, heart rate variability, blood pressure, skin conductance, blood flow into and / or out from at least one body region, for example at least one brain region, and / or blood oxygen level.

[0222] According to some exemplary embodiments, the measurements are performed using at least one detector, for example an electrode or a sensor. In some embodiments, the at least one detector is coupled to the subject body, for example in contact with a skin of the subject and / or is coupled to the subject head. Alternatively, or additionally, the detector comprises at least one sensor, for example an optic sensor or a thermal sensor or any other sensor, located at a distance from the subject body. Optionally, the at least one detector is part of an imaging system, for example X-ray Imaging, Computed Tomography (CT) Scan, Magnetic Resonance Imaging (MRI), functional MRI (fMRI), Ultrasound Imaging, Electroencephalography (EEG), Magnetoencephalography (MEG), and Thermography.

[0223] According to some exemplary embodiments, the system generates one or more observations, at block 103. In some embodiments, the one or more observations are generated based on the measurements received at block 101. In some embodiments, the one or more observations comprise at least one of, observations about the subject state, for example mental state, cognitive state and / or functions state, observations about a biopsychosocial factor, observation regarding success of the subject in reaching at least one goal of the treatment, observations regarding ability of the subject to perform the biofeedback and / or observations regarding changes in the subject body activity.

[0224] According to some exemplary embodiments, the one or more observations comprise a predicted ability of the subject to reach a target goal of at least one additional session of the treatment, for example a following session of the treatment.

[0225] According to some exemplary embodiments, at least one suggestion, for example a suggestion indication, optionally for interaction between the subject and a HCP, for example a therapist, is produced at block 105. In some embodiments, the suggestion indication is produced based on the one or more observations generated at block 103. In some embodiments, the suggestion is generated by selecting a suggestion out of a plurality of suggestions according to the generated observation. In some embodiments, the suggestion is produced or selected using at least one lookup table stored in a memory of the system, indicating a relation between one or moreobservations and one or more suggestions. Alternatively or additionally, the suggestion is produced or selected using at least one formula, model, algorithm, and / or a software program installed in a memory of the system.

[0226] According to some exemplary embodiments, the at least one suggestion indication is a suggestion produced or selected to enhance a therapeutic interaction between the therapist and the subject receiving the therapy. In some embodiments, the at least one suggestion indication comprises a suggestion for a setting or for modifying at least one parameter of a therapy meeting between the therapist and the subject, produced based on the measurements received at block 101 and / or the observations generated at block 103. In some embodiments, the at least one parameter of the therapy meeting comprises at least one of, timing of the meeting, duration of the meeting, participants in the meeting and / or content of the meeting. In some embodiments, a suggestion indication regarding a content of the meeting comprises topics to be discussed during the meeting.

[0227] Alternatively or additionally, the at least one suggestion is a suggestion produced or selected to improve performance and / or experience of the subject during at least one session of the treatment, for example biofeedback treatment, for example at least one biofeedback treatment session scheduled to be performed following the producing of the at least one suggestion at block 105. In some embodiments, the suggestion includes information about one or more modifications of the treatment, for example modifications expected to improve performance and / or experience and / or to increase success of the subject in a following treatment session or in a consecutive session.

[0228] According to some exemplary embodiments, the at least one suggestion indication produced at block 105 is delivered at block 107. In some embodiments, the at least one suggestion indication is delivered to the HCP, for example the therapist, prior to the therapy meeting or during the therapy meeting, for example a psychotherapy meeting. Alternatively or additionally, the at least one suggestion is delivered to the HCP and / or to the subject performing the biofeedback treatment prior to at least one session of the biofeedback treatment, or optionally at a beginning of the at least one session, for example prior to and / or at a beginning of a following biofeedback session. Alternatively or additionally, the at least one suggestion is delivered to the HCP and / or to the subject undergoing the treatment during and / or at an end of a treatment session during which the measurements were taken or during which signals used for the measurements were recorded. In some embodiments, the at last one suggestion indication is delivered as a human detectable indication, for example a visual and / or an audio indication.

[0229] According to some exemplary embodiments, feedback is optionally received at block 108. In some embodiments, the feedback, for example a feedback signal or feedback input is receivedform the HCP and / or from the subject receiving the treatment. In some embodiments, the feedback comprises whether or not the HCP and / or subject noticed the suggestion delivered at block 107. Alternatively or additionally, the feedback comprises feedback information about the subject reaction to the suggestion or to actions performed by the HCP following the suggestion or in view of the suggestion. For example, if the suggestion delivered to the HCP comprises at least one topic for discussion with the subject, the feedback received at block 108 comprises information about the subject reaction to the suggested topic and / or any other insights from the HCP following the discussion with the subject. Optionally the system modifies the generation of observation at bock 103, the production of suggestion at block 105 and / or the delivery of the suggestion, according to the received feedback.

[0230] According to some exemplary embodiments, the feedback is received by the system using at least one user interface of the system. Alternatively, the feedback is received from a remote device in communication with the system.

[0231] Exemplary interactions between a subject, a therapist and a system

[0232] According to some exemplary embodiments, a system is used to characterize a subject, optionally in an objective way, for example to personalize a treatment provided to the subject. In some embodiments, the treatment comprises at least one of, a drug treatment, a psychotherapy treatment, and / or a cognitive behavior therapy (CBT).

[0233] In some embodiments, the system receives measurements that were measured while the subject performs one or more tasks, for example tasks of a predetermined process, or undergoes a planned process. In some embodiments, the process comprises a therapeutic process configured to improve a state of the subject. In some embodiments, the measurements indicate a response of the subject body while performing the one or more tasks and / or while undergoing the planned process.

[0234] In some embodiments, based on the subject characterization, the system generates suggestions that will allow a HCP to increase an efficacy of a therapy meeting with the subject by personalizing one or more parameters of the meeting to the specific subject and / or to the specific subject state.

[0235] Reference is now made to fig. IB, depicting interactions between a HCP, a subject, and at least one system, according to some exemplary embodiments of the invention.

[0236] According to some exemplary embodiments, a subject 109 receives a treatment 111, for example a biofeedback treatment, optionally a neurofeedback. In some embodiments, the subject receives the treatment 111 from a therapy system 113. In some embodiments, the treatment comprises at least one treatment session. In some embodiments, during at least one biofeedbacktreatment session, an indication is presented to the subject 109 by the system 113, and the subject is instructed to perform a task, for example a cognitive task, to modify the indication. In some embodiments, the therapy system performs measurements, optionally measurements of at least one physiological parameter of the subject 109 during the presentation of the indication and modifies the presented indication according to changes in the measurement.

[0237] According to some exemplary embodiments, a different measurements system, for example system 115 receives measurements 117 performed in the subject 109 during the treatment 111. In some embodiments, the measurements 117 indicate activity of the subject body, for example activity of at least one organ, activity of at least one system or activity of at least one pathway which involves two or more organs. Optionally, the measurements indicate activity of at least one brain region or a activity of a network of two or more brain regions.

[0238] Optionally, the system 115 is the same therapy system 113 or a circuitry or module thereof. In some embodiments, the measurements 117 are measurements performed by the therapy system 113 during the biofeedback treatment 111.

[0239] According to some exemplary embodiments, system 115 is system 201 or system 202 shown in figs. 2A and 2B, respectively.

[0240] According to some exemplary embodiments, system 115 processes the measurements 117, and produces based on the processed measurements, one or more suggestions 119 for personalizing an interaction 121, for example a therapy meeting, between the subject 109 and a HCP 123, and / or for improving performance and / or experience of the subject 109 in at least one planned session of the biofeedback treatment 111. In some embodiments, the one or more suggestions are produced in order to increase an efficacy of the therapy meeting 121. In some embodiments, the therapy meeting is scheduled to take place after completion of the treatment 111, for example after completing at least one session of the treatment 111, or is scheduled to take place between two consecutive sessions of the treatment 111.

[0241] According to some exemplary embodiments, for example as shown in fig. 1C, the produced suggestions allows to increase an efficacy of a therapy meeting 125 between the HCP and the subject, which in turn, optionally, leads to an increased efficacy of a biofeedback treatment 127, for example by improving a state of the subject prior the treatment 127, for example prior to at least one session of the treatment 127 and optionally at a beginning of the biofeedback treatment before active biofeedback is initiated. Thereby, both the treatment 127 and the therapy meeting have a synergistic effect that is used to provide a personalized treatment, for example a personalized mental treatment, to the subject, which is more efficacious compared to each of the therapy meeting 125 and the treatment 127, when deliver separately to the subject.According to some exemplary embodiments, the system 115 optionally receives feedback, for example at least one feedback signal from the HCP and / or from the subject 109, for example as described at block 108 of fig. 1A.

[0242] According to some exemplary embodiment, the system 115 is the system performing the method described in fig. 1A.

[0243] Exemplary general process for determining subject performance

[0244] According to some exemplary embodiments, in a biofeedback procedure, for example biofeedback therapy, at least one feedback signal indicating activity of the subject body, is delivered to the subject. In some embodiments, a feedback signal indicating activity of the subject body comprises a feedback signal indicating activity of at least one of a body organ, a pathway, and / or system of the body. In some embodiments, the subject is requested to self-modify the feedback signal and / or the body activity while receiving the at least one signal. In some embodiments, determining performance of the subject in a procedure, for example a biofeedback procedure allows to determine success of the subject in self-modifying the feedback signal and / or in self-modifying the body activity in a desired level, optionally to reach a target goal, for example a target therapeutic goal. Optionally, determining performance of the subject in a procedure allows to determine subject experience in the procedure.

[0245] In some embodiments, determining subject performance during the procedure may assist in reaching a desired performance and / or experience level and / or reaching a target goal of the biofeedback procedure, optionally by identifying difficulties in the subject response and reporting these identified difficulties to a supervisor of the biofeedback procedure, for example an HCP.

[0246] Reference is now made to fig. ID, depicting a general process for determining subject performance in a biofeedback procedure, according to some exemplary embodiments of the invention.

[0247] According to some exemplary embodiments, a biofeedback procedure is delivered to a subject, at block 102. In some embodiments, the biofeedback procedure is a biofeedback therapy for treating at least one disorder or illness of the subject. In some embodiments, the biofeedback procedure is a procedure for treating a mental disorder of the subject.

[0248] Alternatively or additionally, the biofeedback procedure is a procedure for training the subject to modify activity of the subject body or an indication of the subject body activity, in a target direction, for example increase or decrease activity. In some embodiments, the biofeedback procedure is a procedure for training the subject to modify activity of at least one organ, at least onepathway, at least one brain region, at least one brain network and / or at least one brain system, in a target direction,

[0249] Alternatively or additionally, the biofeedback procedure is a procedure for training the subject to modify at least one feedback signal indicating the body activity, in the target direction.

[0250] According to some exemplary embodiments, the biofeedback procedure includes at least one session, for example a training or a treatment session. In some embodiments, during the biofeedback session, at least one feedback signal indicating an activity of at least one portion of the subject body is continuously delivered to the subject.

[0251] According to some exemplary embodiments, at least one score indicating performance of the subject in the biofeedback procedure is calculated at block 104. In some embodiments, the at least one score indicates a degree of performance or a level of performance of the subject in the biofeedback procedure, for example in performing the biofeedback procedure and / or in reaching a target goal of the biofeedback procedure. Alternatively or additionally, the calculated score indicates performance of the subject when trying to modify a body response, for example modifying activity of at least one organ, of at least one pathway, of at least one brain region, of at least one brain network and / or of at least one brain system. Alternatively or additionally, the calculated score indicates performance of the subject in modifying at least one feedback signal delivered to the subject during the biofeedback procedure.

[0252] According to some exemplary embodiments, the at least one score is calculated during the biofeedback session, and optionally indicates a current performance of the subject in the biofeedback procedure. Alternatively or additionally, the at least one score is calculated following the biofeedback session and optionally indicates an overall performance of the subject in the biofeedback session. In some embodiments, the at least one score is calculated continuously, for example with intervals shorter than 1 second, or intermittently, for example in intervals longer than 1 second.

[0253] According to some exemplary embodiments, the at least one score is calculated based on recordings of at least one signal from the subject body. Alternatively or additionally, the at least one score is calculated based on measurement of changes in the feedback signal presented to the subject. In some embodiments, the feedback signal comprises an audio and / or a visual signal. In some embodiments, the feedback signal comprises a sensory interface, for example a visual and / or an audio interface presented to the subject during the biofeedback procedure. In some embodiments, the at least one score is calculated based on the changes in the sensory interface.

[0254] According to some exemplary embodiments, success of the subject in the biofeedback procedure is determined at block 106. In some embodiments, the success of the subject in thebiofeedback procedure is determined based on the score calculated at block 104. Additionally or optionally, the success of the subject is determined based on one or more additional measurements, for example measurements of at least one physiological parameter. In some embodiments, the at least one physiological parameter comprises at least one of, heart rate, blood pressure, skin conductivity, heart rate variability, and oxygen saturation. In some embodiments, the one or more additional measurements comprise measurements of the body posture and / or movement.

[0255] According to some exemplary embodiments, determining subject success comprises determining if the subject performance is lower than a target performance, for example a desired performance, or according to the target performance.

[0256] According to some exemplary embodiments, an indication about the determined subject success is generated at block 131. In some embodiments, the indication is a human detectable indication, for example an audio and / or a visual indication.

[0257] According to some exemplary embodiments, instructions how to maintain and / or improve success of the subject are optionally delivered at block 133. In some embodiments, the instructions comprise instructions to interact, for example to communicate and / or to perform an activity, with the subject. In some embodiments, the instructions are delivered during the biofeedback session, and / or following the biofeedback session. In some embodiments, the instructions are part of, or are included in the indication generated at block 131.

[0258] According to some exemplary embodiments, the biofeedback procedure is delivered at block 102 using a biofeedback system. In some embodiments, the biofeedback system or a different system is used for steps 104, 106, 131 and 133, for calculating the score at block 104, determining subject success at block 106, generating indication at block 131, and / or for optionally delivery the instructions at block 133.

[0259] Exemplary system

[0260] According to some exemplary embodiments, a subject receives a treatment which is optionally a training procedure used to train the subject to cope with a disorder or at least one symptom of a disorder, using a system. In some embodiments, the treatment comprises biofeedback training, and the system is configured to deliver the biofeedback training, for example neurofeedback training by presenting at least one feedback signal to the subject and modifying the presented feedback signal online, for example in a delay shorter than 1 minute, shorter than 30 seconds, shorter than 10 seconds, shorter than 5 seconds, shorter than 3 seconds, shorter than 1 seconds, or any intermediate, smaller or large time period, according to changes in measurements recorded from the subject body.According to some exemplary embodiments, the system delivering the biofeedback training is used to generate observations based on measurements received from at least one detector, and produce at least one suggestion for an HCP-subject interaction according to the observations, for example as described in fig. 1A.

[0261] Reference is now made to fig. 2A, depicting a system for delivery of biofeedback treatment and / or for producing suggestions based on measurements from at least one detector, according to some exemplary embodiments of the invention.

[0262] According to some exemplary embodiments, a system 201 comprises a control unit 203, configured to deliver biofeedback therapy, for example biofeedback training to a subject, and / or to produce suggestions, for example suggestions for interaction between a HCP and the subject or other suggestions produced in order to maintain or increase performance of a subject in the training. In some embodiments, the control unit 203 is a computer.

[0263] According to some exemplary embodiments, the control unit 203 comprises a control circuitry 205 and a memory circuitry 207. In some embodiments, the memory circuitry 207 stores at least one program and / or parameters of a biofeedback therapy protocol. Additionally or alternatively, the memory circuitry 207 stores at least one algorithm, formula and / or a lookup table, for processing measurements received from at least one detector, generate subject-related observations and produce the suggestions based on the generated observations.

[0264] According to some exemplary embodiments, the control unit 203 comprises or is functionally connected to a user interface 209. In some embodiments, the user interface 209 is configured to generate and deliver one or more indications to a subject 211, for example a human subject. In some embodiments, the one or more indications comprise human detectable indications. Additionally or optionally, the user interface 209 is configured to receive input from a subject, for example a user of the system receiving the biofeedback therapy, and from a HCP, for example a supervisor of the biofeedback therapy or a professional treating the subject.

[0265] According to some exemplary embodiments, the user interface 209 is functionally coupled to at least one speaker 213 configured to generate and deliver an audio indication to the subject 211. In some embodiments, the user interface 209 is functionally coupled to a display 215 configured to generate and deliver a visual indication to the subject 211.

[0266] According to some exemplary embodiments, the control circuitry 205 is functionally coupled to at least one detector, configured to record directly or indirectly at least one signal from the subject 211. In some embodiments, the at least one detector comprises at least one head detector 217 coupled to a head 219 of the subject 211. In some embodiments, the at least one head detector 217 comprises at least one sensor, for example an accelerometer, a gyroscope and / or an inertialmeasurement unit (IMU), for detecting movements of the head 219. Alternatively or additionally, the at least one head detector 217 comprises at least one electrode, optionally an array of electrodes, for recording brain activity signals from the subject 211. In some embodiments, the at least one electrode is an electroencephalogram (EEG) electrode.

[0267] According to some exemplary embodiments, the at least one detector comprises to at least one body detector 221 functionally coupled to the subject body 223. In some embodiments, the at least one body detector 221 comprises at least one sensor or electrode for measuring at least one of, body movement, body orientation, and / or at least one physiological parameter of the body 223. In some embodiments, the at least one physiological parameter comprises at least one of, heart rate, heart rate variability, cardiac function, skin conductivity, blood pressure, and oxygen saturation. In some embodiments, the at least one body detector 221 is part of a wearable unit, for example a smart watch, a ring, a patch, a bracelet and / or a head attachment, attached or coupled to the subject body 223 before, during and / or after the subject 211 receives the biofeedback therapy, for example during at least one session of the biofeedback treatment in which a feedback indication presented to the subject is modified according to measurements performed by the at least one head detector 217 and / or the at least one body detector 221.

[0268] According to some exemplary embodiments, the control circuitry 205 is functionally connected to at least one optic sensor, for example a camera 225. In some embodiments, the camera 225 is configured to record signals indicating posture and / or movement of the subject 211, for example movements of the subject head 219 and / or movements of the subject body 223.

[0269] According to some exemplary embodiments, the control unit 203 is configured to deliver a biofeedback therapy to the subject 211 using at least one treatment protocol stored in the memory 207. In some embodiments, the control circuitry 205 signals the user interface 209 to generate and deliver a feedback signal to the subject 211, optionally using at least one of, the display 215 and the speaker 213. In some embodiments, the control circuitry 205 is configured to receive signals from the at least one head detector 217 and / or from the at least one body detector 221, and to change the feedback signal delivered to the subject based on the received signals.

[0270] According to some exemplary embodiments, the control unit 203 further comprises a communication circuitry 227 configured to communicate, for example to transmit and / or receive signals from at least one additional device, for example a HCP device 229 or a remote device 231. In some embodiments, the communication circuitry 227 is in communication with the HCP device 229 via the remote device 231. In some embodiments, the remote device 231 comprises a computer, a server, a mobile device and / or cloud storage. In some embodiments, the HCP device 229 comprises a computer or a mobile device configured to deliver one or more indications and / or toreceive input from at least one HCP 233 of the biofeedback treatment. The HCP 233 is an expert, a physician, a therapist and / or a caregiver of the subject 211 undergoing the biofeedback therapy.

[0271] According to some exemplary embodiments, during and / or following the delivery of the biofeedback therapy the control unit 203, for example the control circuitry 205 receives signals from the at least one body detector 221, from the at least one head detector 217 and / or from the camera 225. Alternatively or additionally, the control circuitry 205 performs measurements regarding changes in the feedback signal generated and delivered via the user interface 209 to the subject 211. In some embodiments, the control circuitry 205 is configured to calculate at least one score indicating success of the subject in the biofeedback therapy and / or at least one score indicating a change in activity of the subject body. In some embodiments, the control circuitry 205 is configured to calculate the at least one score based on the received signals and / or the performed measurements, using at least software, algorithm, formula and / or lookup table stored in the memory 207.

[0272] According to some exemplary embodiments, the control circuitry 205 is configured to generate at least one observation, for example an observation indication, based on the at least one calculated core and / or signals received form at least one detector 217 and / or 221, and / or based on measurements performed by the control circuitry 205 regarding activity of the subject body, for example activity of at least one region, organ, pathway or system of the subject body.

[0273] According to some exemplary embodiments, the control circuitry 205 is configured to produce at least one suggestion, for example a suggestion for setting or modifying at least one parameter of an interaction between the HCP and the subject, based on the at least one generated observation. In some embodiments, the control circuitry 205 is configured to produce the at least one suggestion using at least one algorithm, lookup table, formula and / or software program, stored in the memory 207. In some embodiments, the memory 207 includes a plurality of predetermined suggestions or indications thereof. In some embodiments, the control circuitry 205 produces the at least one suggestion by selecting the at least one suggestion from the plurality of suggestions stored in the memory 207. Optionally, the at least one algorithm, lookup table, formula and / or software program, stored in the memory 207 are used to determine a relation between the at least one observation and at least one suggestion of the plurality of suggestions.

[0274] According to some exemplary embodiments, the system 201 delivers the at least one suggestion or indication thereof, to the HCP 233 following at least one session of the biofeedback treatment, prior to a following session or at a beginning of the following session, for example prior to or during a discussion between the subject and the HCP at a beginning or during a following session. In some embodiments, the system 201 delivers the at least one suggestion to the HCP viathe HCP device 229, for example by signaling a communication circuitry 227 to transmit at least one signal with information about the at least one suggestion to the HCP device 229.

[0275] Alternatively, the system 201 delivers the at least one suggestion or indication thereof to a remote device 231 which is optionally a server and / or a cloud storage that stores the received data, and optionally delivers the data to the HCP device.

[0276] According to some exemplary embodiments, the remote device 231 is configured to at least one of, process measurements received form the at least one detector, generate the at least one observation and / or produce the at least one suggestion, instead of the control unit 203 or in synchronization with the control unit 203.

[0277] According to some exemplary embodiments, the system 201 is configured to generate a database with information about generated observations and produced suggestion related to a plurality of subjects, optionally with respect to specific sub-populations. In some embodiments, the database is stored or generated by the remote device 231. In some embodiments, the database is used to improve at least one process for generating observations and / or for producing suggestions.

[0278] According to some exemplary embodiments, the system which delivers the biofeedback treatment determines performance of the subject in the biofeedback treatment. Alternatively a system different from the system delivering the biofeedback training determines the subject performance. In some embodiments, the system determines the subject performance quantitatively, for example based on signals recorded from the subject, signals recorded indicating subject state, and / or based on measurements related to the biofeedback system, for example measurements related to the at least one feedback signal.

[0279] Reference is now made to fig. 2B, depicting a system for delivery of biofeedback treatment and / or for determining subject performance, according to some exemplary embodiments of the invention.

[0280] According to some exemplary embodiments, a system 202 comprises a control unit 204, configured to deliver biofeedback therapy, for example biofeedback training to at least one subject, and / or to determine a performance of the subject with te biofeedback therapy. In some embodiments, the control unit is a computer.

[0281] According to some exemplary embodiments, the control unit 204 comprises a control circuitry 206 and a memory circuitry 208. In some embodiments, the memory circuitry 208 stores at least one program and / or parameters of a biofeedback therapy protocol. Additionally or alternatively, the memory circuitry 208 stores at least one algorithm, formula and / or a lookup table, for determining a performance of the subject with the biofeedback therapy.According to some exemplary embodiments, the control unit 204 comprises or is functionally connected to a user interface 210. In some embodiments, the user interface 210 is configured to generate and deliver one or more indications to a subject 211, for example a human subject. In some embodiments, the one or more indications comprise human detectable indications. Additionally or optionally, the user interface 210 is configured to receive input from a subject, for example a user of the system receiving the biofeedback therapy and a supervisor of the biofeedback therapy.

[0282] According to some exemplary embodiments, the user interface 210 is functionally coupled to at least one speaker 212 configured to generate and deliver an audio indication to the subject 211. In some embodiments, the user interface 210 is functionally coupled to a display 214 configured to generate and deliver a visual indication to the subject 211.

[0283] According to some exemplary embodiments, the control circuitry 206 is functionally coupled to at least one detector, configured to record directly or indirectly at least one signal from the subject 211. In some embodiments, the at least one detector comprises at least one head detector 216 coupled to a head 218 of the subject 211. In some embodiments, the at least one head detector 216 comprises at least one sensor, for example an accelerometer, a gyroscope and / or an inertial measurement unit (IMU), for detecting movements of the head 218. Alternatively or additionally, the at least one head detector 216 comprises at least one electrode, optionally an array of electrodes, for recording brain activity of the subject 211. In some embodiments, the at least one electrode is an electroencephalogram (EEG) electrode.

[0284] According to some exemplary embodiments, the control circuitry 206 is functionally connected to at least one body detector 220 functionally coupled to the subject body 222. In some embodiments, the at least one body detector 220 comprises at least one sensor or electrode for measuring at least one of, body movement, body orientation, and / or at least one physiological parameter of the body 222. In some embodiments, the at least one physiological parameter comprises at least one of, heart rate, heart rate variability, cardiac function, skin conductivity, blood pressure, and oxygen saturation. In some embodiments, the at least one body detector 220 is part of a wearable unit, for example a smart watch, a ring, a patch, a bracelet and / or a head attachment, attached or coupled to the subject body 220 before, during and / or after the subject 211 receives the biofeedback therapy.

[0285] According to some exemplary embodiments, the control circuitry 206 is functionally connected to at least one optic sensor, for example a camera 224. In some embodiments, the camera 224 is configured to record signals indicating posture and / or movement of the subject 211, for example movements of the subject head 218 and / or movements of the subject body 222.According to some exemplary embodiments, the control unit 204 is configured to deliver a biofeedback therapy to the subject 211 using at least one treatment protocol stored in the memory 208. In some embodiments, the control circuitry 206 signals the user interface 210 to generate and deliver a feedback signal to the subject 211 using at least one of, the display 214 and the speaker 212. In some embodiments, the control circuitry 206 is configured to receive signals from the at least one head detector 216 and / or from the at least one body detector 220, and to change the feedback signal delivered to the subject based on the received signals.

[0286] According to some exemplary embodiments, the control unit 204 further comprises a communication circuitry 226 configured to communicate, for example to transmit and / or receive signals from at least one additional device, for example a supervisor device 228 or a remote device 230. In some embodiments, the communication circuitry 226 is in communication with the supervisor device 228 via the remote device 230. In some embodiments, the remote device 230 comprises a computer, a server, a mobile device and / or cloud storage. In some embodiments, the supervisor device 228 comprises a computer or a mobile device configured to deliver one or more indications and / or to receive input from at least one supervisor 232 of the biofeedback treatment. The supervisor 232 is an expert, a physician, a therapist and / or a caregiver of the subject 211 undergoing the biofeedback therapy.

[0287] According to some exemplary embodiments, during and / or following the delivery of the biofeedback therapy the control unit 204, for example the control circuitry receives signals from the at least one body detector 220, from the at least one head detector 216 and / or from the camera 224. Alternatively or additionally, the control circuitry 206 performs measurements regarding changes in the feedback signal generated and delivered via the user interface 210 to the subject 211. In some embodiments, the control circuitry 206 is configured to calculate a score indicating performance of the subject in the biofeedback therapy based on the received signals and / or the performed measurements using at least software, algorithm, formula and / or lookup table stored in the memory 208. In some embodiments, the control circuitry 206 is configured to determine performance, for example performance level, level of the subject 211 in the biofeedback therapy and / or success of the subject in the biofeedback therapy based on the calculated score.

[0288] According to some exemplary embodiments, the control unit 204, for example the control circuitry 206 is configured to signal the communication circuitry 226 to generate and deliver an indication regarding the determined performance and / or success to the supervisor 232, via the supervisor device 228 or the remote device 230. In some embodiments, the indication, for example a suggestion indication delivered to the supervisor includes instructions how to maintain or increase a current level of performance and / or success.According to some exemplary embodiments, the system 202 is configured to generate a database with information about performance or success of a single subject or about performance or success of a plurality of subjects, optionally divided into sub-populations. In some embodiments, the system 202 is configured to transmit data comprising signals received from the subject 211 and / or information regarding performance and / or success of the subject 211 to the remote device 230 which is optionally a server and / or a cloud storage that stores and / or processes the received data.

[0289] According to some exemplary embodiments, the database includes information regarding an expected performance and / or expected success of one or more subjects and / or of expected performance and / or success of specific sub-population of subjects. For example, expected performance and / or success of a subject, diagnosed with a specific disorder, optionally a specific mental disorder, a subject receiving one or more specific drugs, a subject with a specific age or in a range of ages, a subject with a specific medical history, and / or a subject with a specific family history.

[0290] According to some exemplary embodiments, the system or at least one component thereof shown in figs. 2A and 2B, is used in the methods described in figs. 1A and ID.

[0291] According to some exemplary embodiments, a user interface of the system, for example user interface 209 or user interface 210, is used to generate a human detectable indication, for example an audio and / or a visual indication, and to deliver the human detectable indication optionally to the subject and / or to a HCP. In some embodiments, the user interface is used to receive input, and optionally feedback form the HCP and / or from the subject. Optionally, the user interface is used to receive information about at least one mental strategy, for example a cognitive task applied by the subject. In some embodiments, the information about the at least one mental strategy is received during a treatment session and / or following a treatment session, and is optionally stored in a memory of the system. In some embodiments, the information about the at least one mental strategy is used by the control circuitry when generating at least one observation and / or when generating at least one suggestion.

[0292] According to some exemplary embodiments, a memory of a system, for example memory 207 or memory 208, stores measurements or changes thereof of at least one physiological parameter measured during at least one session of a treatment and / or following the at least one treatment session. In some embodiments, the measurements indicate a response or changes thereof of the subject body to at least one sensory interface presented to the subject during the at least one treatment session. In some embodiments, the measurements comprise measurements of brainactivity, for example EEG measurements, fMRI measurements or any type of measurements which indicate activity of one or more brain targets.

[0293] According to some exemplary embodiments, a control circuitry, for example the control circuitry 205 or 206, is configured to process the measurements stored in the memory to determine performance of the subject in the at least one treatment session. In some embodiments, the control circuitry is configured to produce at least one suggestion indication according to the determined performance. In some embodiments, the at least one suggestion indication comprises information about one or more ways to maintain or improve performance of the subject in at least one additional session of the treatment, compared to the determined performance in the at least one treatment session, or compared to a reference performance level. In some embodiments, the control circuitry is configured to signal a user interface, for example user interface 209 or 210, to generate and deliver the at least one human detectable indication with the at least one suggestion indication, optionally to a healthcare professional (HCP) and / or to the subject receiving the treatment or training.

[0294] According to some exemplary embodiments, following delivery of the at least one suggestion, the control circuitry receives at least one feedback signal, from the HCP and / o from the subject, optionally with feedback information about the at least one suggestion. In some embodiments, optionally, the control circuitry modifies the previously generated suggestion or generates at least one different suggestion based on the received feedback information.

[0295] According to some exemplary embodiments, the treatment comprises a neurofeedback (NF) treatment or training, in which a subject is trained to modulate activity of at least one brain target in a target direction, for example to upregulate or downregulate the activity of the at least one brain target, by performing at least one cognitive task, optionally before and / or during a treatment session. In some embodiments, the control circuitry is configured to process the measurements to determine performance of the subject in the at least one treatment session, for example by determining an ability of the subject to modulate activity of the at least one brain target in a desired direction, for example a target direction by performing the cognitive task. In some embodiments, the control circuitry calculates a performance score based on the determined ability, and produces the at least one suggestion based on the calculated performance score.

[0296] According to some exemplary embodiments, the control circuitry produces at least one suggestion indication with a suggestion to modify the at least one cognitive task performed by the subject or to perform a different cognitive task, if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a targetperformance level. Optionally, the memory stores information about the at least one cognitive task performed by the subject and / or other cognitive activities.

[0297] Alternatively, the control circuitry produces at least one suggestion indication with a suggestion to stop or modify the NF treatment, optionally if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

[0298] Alternatively, the control circuitry produces at least one suggestion indication with a suggestion to replace or combine the treatment, for example NF treatment with at least one additional treatment, optionally if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level. In some embodiments, the at least one additional treatment comprises at least one of, psychotherapy, cognitive behavioral treatment (CBT) and at least one drug treatment.

[0299] Exemplary determining performance of a subject in a task

[0300] According to some exemplary embodiments, when a subject undergoes a treatment procedure, for example a training procedure, the subject is requested to follow instructions and / or to follow a protocol of the treatment. In some embodiments, during the treatment, for example biofeedback therapy, the subject receives instructions to perform a task. In some embodiments, when delivering the biofeedback therapy to a subject, the instructions include instructions to modify a feedback signal, for example by performing physical activity and / or mental activity. In some embodiments, the instructions include instructions to find and apply a mental strategy. In some embodiments, applying a mental strategy comprises performing at least one cognitive task or at least one mental activity. In some embodiments, for example in a case that the biofeedback therapy is a neurofeedback therapy or training, performing a mental strategy affects activity of at least one brain target. Optionally, the mental strategy is selected and / or is designed to affect activity of the at least one brain target.

[0301] A potential advantage of determining if a subject performs the instructions and / or acquires a desired mental strategy may allow a supervisor to detect difficulties of the subject and provide necessary assistance in order to increase performance and / or success of the subject in the treatment, optionally by assisting the subject in finding a mental strategy that when applied allows to reach a desired, for example a target performance and / or a target self-modulation of the at least one brain target.

[0302] Reference is now made to fig. 3 depicting a process for determining success of a subject in a treatment, according to some exemplary embodiments of the invention.According to some exemplary embodiments, at least part of the process described in fig. 3 is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0303] According to some exemplary embodiments, a system configured to deliver therapy, for example biofeedback therapy to a subject, optionally provides instructions to the subject to perform a cognitive task at block 302. In some embodiments, a cognitive task comprises a mental task, optionally configured to be performed in the subject brain. In some embodiments, the cognitive task comprises a mental task that is personalized for the subject or that is selected by the subject. In some embodiments, the delivered instructions comprise instructions to initiate a mental task, and / or instructions with a description of the mental task. In some embodiments, the system delivers the instructions using the user interface 210 shown in fig. 2B.

[0304] According to some exemplary embodiments, the system receives input data, at block 304. In some embodiments, the input data comprises signals received from one or more detectors, for example the body detector 220 and / or the head detector 216, shown in fig. 2B. In some embodiments, the signals indicate levels of one or more physiological parameters, and / or changes thereof. In some embodiments, the one or more physiological parameters comprise, heart rate, heart rate variability, cardiac activity, blood pressure, skin electrical conductivity, body movements and / or brain activity.

[0305] According to some exemplary embodiments, the system calculates a score indicating performance of the subject in the cognitive task, at block 306. In some embodiments, the system, for example control circuitry 205 or 206 shown in figs. 2A and 2B, calculates the score based on the input data received at block 304, and optionally using at least one algorithm, formula, and / or a lookup table stored in the memory 207 or memory 208.

[0306] According to some exemplary embodiments, the system determines a relation between the calculated score and at least one reference value, at block 308. In some embodiments, the system, for example control circuitry 205 or 206 determines a relation between the calculated score and at least one reference stored in the memory 207 or 208, optionally using at least one algorithm, formula, and / or a lookup table stored in the memory 207 or 208.

[0307] According to some exemplary embodiments, the system is configured to determine success of the subject in a treatment, at block 310. In some embodiments, determining success of the subject in the treatment comprises determining success of the subject in the treatment session during which the input data was received. Alternatively, determining success of the subject comprises predicting subject success in the following treatment session. In some embodiments, the system, for examplecontrol circuitry 206 determines subject success in applying the cognitive task based on the relation determined at block 308. For example, if the calculated score is higher than a reference value indicating a target success level, then the determined success is sufficient for continuing with the biofeedback therapy. For example, if the calculated score is lower than the reference value, then the determined success is too low for continuing with the biofeedback therapy.

[0308] According to some exemplary embodiments, the system optionally determines experience of the subject in interacting with the treatment process, for example experience of the subject in interacting with a system delivering the treatment process, with the system interface delivered to the subject during the treatment process and / or with the treatment protocol, for example a training protocol, based on the determined success. In some embodiments, in case of a biofeedback therapy or training, optionally neurofeedback training, the system determines whether an optimal mental strategy was used by the subject in order to modify a feedback signal and / or body activity, for example activity of at least one brain target. In some embodiments, the system determines whether the subject used an optimal mental strategy to modulate the feedback signal and / or brain target activity in a desired target direction (upregulate or downregulate), and / or in a desired target modulation degree.

[0309] According to some exemplary embodiments, the system generates an indication, for example an observation indication with regard to the determined success, at block 312. Optionally, the system delivers the generated indication to a remote device, for example the remote device 230 and / or stores the generated indication in the memory 208. In some embodiments, the generated indication comprises information on the score calculated at block 306, the relation determined at block 310 and / or information regarding the subject, for example medical and / or personal information.

[0310] According to some exemplary embodiments, the generated indication comprises information about the determined performance, the determined success and / or about the subject experience with the treatment. In some embodiments, the generated indication comprises information about one or more factors affecting the determined subject performance and / or the determined subject success. In some embodiments, the one or more factors comprise at least one biopsychosocial factor, at least one factor related to the interaction of the subject with the system, with the system interface and / or with the system protocol.

[0311] According to some exemplary embodiments, the generated indication is delivered to the HCP and / or to the subject during the treatment session or at an end of the treatment during which the input data is received at block 304. Alternatively or additionally, the indication is delivered tothe HCP and / or to the subject prior to a following treatment session, or during the following treatment session, for example in a beginning of the following treatment session.

[0312] According to some exemplary embodiments, optionally, the system delivers instructions how to maintain and / or to improve subject performance and / or success, at block 314. In some embodiments, the instructions comprise suggestions how to maintain and / or how to improve subject experience, with the treatment. In some embodiments, the instructions are delivered to a HCP, for example a HCP supervising the treatment delivered to the subject. Optionally, the instructions are delivered to the supervisor device 228 using the communication circuitry 226, optionally via the remote device 230, shown in fig. 2B.

[0313] Exemplary determining success of a subject in a NF treatment

[0314] According to some exemplary embodiments, a subject optionally diagnosed with a mental disorder receives a neurofeedback treatment. In some embodiments, during the neurofeedback treatment the subject is instructed to modify a feedback signal indicating activity of the subject nervous system, for example activity of the subject brain. In some embodiments, the feedback signal indicates activity of at least one brain target, for example a cortical or a sub-cortical brain region, activity of at least one brain system, and / or activity of at least one brain network.

[0315] According to some exemplary embodiments, the subject is instructed to modify the feedback signal by requesting the subject to perform a cognitive, for example a mental task. In some embodiments, the mental task comprises thinking about a scenario or acquiring a mental strategy, for example a relaxing or a stressing scenario or mental strategy. Optionally, the scenario or mental strategy is an emotional scenario or an emotional mental strategy, designed to affect an emotional state of the subject.

[0316] According to some exemplary embodiments, in order to succeed in the neurofeedback treatment it is optionally important that the subject is sufficiently engaged with performing the instructions, for example with instructions to perform the mental task. Alternatively or additionally, it is optionally important that the subject is sufficiently engaged with the NF process in order to find a mental task that when applied by the subject it allows to modulate activity of at least one brain region, at least one brain network and / or at least one brain system. A potential advantage of determining performance of the subject during neurofeedback, may be to detect difficulties of the subject in interacting with the system, treatment protocol and / or with applying an optimal mental strategy, when practicing the treatment, optionally in order to prevent frustration and / or abandonment of the NF treatment. In some embodiments, the performance of the subject is optionally determined based on the success of the subject in self-modulating the activity of the atleast one brain target, in a target direction (upregulate or downregulate) and / or in desired modulation degree.

[0317] Reference is now made to fig. 4A, depicting a method for determining success of a subject in performing a NF treatment for example NF training, according to some exemplary embodiments of the invention.

[0318] According to some exemplary embodiments, at least part of the process described in fig. 4A is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0319] According to some exemplary embodiments, a subject diagnosed with a mental disorder is optionally selected for a NF treatment, at block 402. In some embodiments, the subject is diagnosed with a mental disorder, for example by diagnosing the subject with at least one symptom of the mental disorder. In some embodiments, the subject is diagnosed by an expert. In some embodiments, the subject is diagnosed based on the expert impression and / or using at least one assessment tool, for example an assessment questionnaire.

[0320] Additionally, the subject is selected for the NF treatment based on an expert impression that the subject is capable to engage the NF treatment, to perform the NF treatment instructions and / or that the subject is capable of finding a mental task that when performed will lead to success in the NF treatment.

[0321] According to some exemplary embodiments, the subject is selected for a NF treatment that includes performing of at least one NF treatment session, for example two or more NF treatment sessions.

[0322] According to some exemplary embodiments, information about the selected subject is inserted to a memory of a system, for example as described in figs. 2A and 2B. In some embodiments, the information includes information of the mental disorder, for example mental disorder severity and / or information about at least one symptom of the mental disorder.

[0323] According to some exemplary embodiments, a NF protocol is selected or an existing NF protocol is modified according to the inserted information, automatically by the system or by a supervisor or provider of the NF treatment.

[0324] According to some exemplary embodiments, a NF session is initiated at block 404. In some embodiments, the NF session is initiated by the system.

[0325] According to some exemplary embodiments, at least one sensory feedback interface is presented to the subject at block 406. In some embodiments, the at least one sensory feedback interface is presented by the system, for example system 202. In some embodiments, the sensoryfeedback interface comprises at least one visual interface and / or at least one audio interface. In some embodiments, the sensory feedback interface is a dynamic changeable interface configured to be changed according to one or more signals recorded from the subject body, for example from the subject brain, or according to changes in the one or more signals. In some embodiments, the one or more signals indicate brain activity or changes thereof of at least one brain region, for example a cortical brain region or a subcortical deep brain region. In some embodiments, a system is configured to change the sensory feedback interface at least every 5 seconds, for example at least every 2 seconds, at least every 1 second or any intermediate, shorter or longer time period.

[0326] According to some exemplary embodiments, the at least one sensory feedback interface is delivered to the subject using the user interface 210, optionally via speaker 212 and / or display 214, shown in fig. 2B.

[0327] According to some exemplary embodiments, instructions to modify the at least one sensory feedback interface is delivered to the subject, at block 408, optionally by the system. In some embodiments, the instructions to modify the at least one sensory interface are provided by a supervisor of the NF treatment. Alternatively, the instructions are delivered to the subject using the user interface optionally via the speaker and / or the display shown in figs. 2A and 2B. In some embodiments, the instructions include instructions to perform one or more mental tasks or to find one or more mental tasks that when applied will results in a desired, for example a target change in the sensory feedback interface presented to the subject.

[0328] In some embodiments, changing the sensory feedback interface in a target direction, for example into a target or a desired sensory feedback interface, indicate that activity of at least one brain target, for example activity of at least one brain region, activity of at least one brain system and / or activity of at least one brain system is modified, optionally in a desired direction, in response to performing of the one or more mental tasks, for example the activity of the at least one brain target is downregulated or upregulated.

[0329] According to some exemplary embodiments, input is received at block 410, optionally by the system. In some embodiments, the received input comprises signals measured form a subject brain, optionally using the at least one head detector 216 shown in fig. 2B. In some embodiments, when the head detector 216 comprises one or more electrodes, the input comprises EEG signals, or any other signals indicating brain activity, for example brain activity of the at least one brain target.

[0330] Alternatively or additionally, the input received at block 410 comprises signals received from the at least one body detector 220. In some embodiments, the received signals indicate changes in at least one physiological parameter, for example heart rate, heart rate variability, cardiac activity, blood pressure, muscle response and / or skin conductivity.According to some exemplary embodiments, the input is received at block 410 during the presentation of the sensory feedback interface at block 406.

[0331] According to some exemplary embodiments, the sensory feedback interface is modified at block 412, by the system. In some embodiments, the sensory feedback interface is modified based on input signals received at block 410. In some embodiments, modifying the sensory feedback interface comprises changing at least one graphical visual signal and / or at least one audio signal which is part of the sensory feedback interface, in response to the received input signals.

[0332] According to some exemplary embodiments, the system ends the NF session, at block 413. According to some exemplary embodiments, a score indicating success of the subject in modifying the sensory feedback interface, is calculated at block 414, optionally by the system. In some embodiments, a success score indicates an ability of the subject to modify the sensory feedback interface in a desired way. Optionally, the success score indicates performance, or experience of the subject in interacting with the NF treatment, for example with the system delivering the NF treatment and / or with the NF treatment protocol. In some embodiments, the calculated score indicates a success of the subject in modifying the sensory interface in a desired direction which further indicates a change in an activity of the at least one brain target in a desired direction.

[0333] According to some exemplary embodiments, a relation between the calculated score and at least one reference value is determined at block 416, optionally by the system. In some embodiments, determining a relation comprises comparing the calculated score to the at least one reference value, to a range of reference values or to a modification or a variation of the reference value or range of values.

[0334] According to some exemplary embodiments, success of the subject in the NF is determined at block 418, optionally by the system. In some embodiments, the subject success is determined based on the score calculated at block 414 and / or the relation determined at block 416. In some embodiments, determining success of the subject comprises determining if the subject success in the NF session is sufficient in order to reach a desired goal of the NF treatment. In some embodiments, the desired goal of the NF comprises teaching a subject to control and / or prevent an emotional response, optionally when being exposed to a trigger in everyday activities. Alternatively or additionally, a desired goal of the NF comprises finding and optionally learning how to apply a mental task that when applied by the subject attenuates or prevents the emotional response, optionally to a specific trigger.

[0335] Alternatively or additionally, a desired goal of the NF comprises finding and optionally learning how to apply a mental task that when applied by the subject delays, attenuates and / orprevents occurrence of at least one symptom of a mental disorder of the subject. In some embodiments, in case the subject is diagnosed with a stress disorder, for example PTSD, the at least one symptom comprises, having flashbacks, trouble sleeping, nightmares, feeling alone or detached from others, losing interest in activities, having angry outbursts or other extreme reactions, feeling worried, guilty or sad, having frightening thoughts and / or having trouble concentrating. In some embodiments, in case the subject is diagnosed with depression, the at least on symptom comprises feeling sad, empty anxious, helpless, worthless, guilty, helpless, irritable, restless, less interest in activities, less energetic, having difficulties in concentrating, having changes in sleep routine, having changes in appetite, and / or having aches and pains.

[0336] According to some exemplary embodiments, success of the subject is determined with respect to a NF session currently delivered to the subject or to a session that was just finished. Alternatively, success of the subject is determined with respect to at least one following session, for example with respect to the following session, optionally planned to be delivered to the subject at least 2, 6, 12, 24 hours from completing the previous session.

[0337] According to some exemplary embodiments, a subject state is optionally determined at block 420, optionally by the system. In some embodiments, the subject state is optionally determined based on the score calculated at block 414 and / or the relation determined at block 416. In some embodiments, determining a subject state comprises determining a mental and / or a cognitive state of the subject.

[0338] According to some exemplary embodiments, one or more indications, for example human detectable indications are provided to a HCP, for example to a supervisor of the NF treatment, based on the subject success determined at block 418 and / or based on the subject state determined at block 420. In some embodiments, the one or more indication comprises at least one suggestion. Optionally the at least one suggestion comprises at least one instruction to perform at least one activity. In some embodiments, the at least one suggestion is provided by the system to HCP, for example a physician, a therapist, a psychologist, a social worker, or a psychiatrist. In some embodiments, the at least one suggestion is generated and provided based on the determined subject success and / or the determined subject state.

[0339] According to some exemplary embodiments, the system optionally generates and provides at least one suggestion to stop the NF treatment, at block 422. In some embodiments, the system provides a suggestion to stop the NF session based on the determined success of the subject and / or based on the determined state of the subject. In some embodiments, the system provides a suggestion to stop the NF session if the determined subject success indicates that the subject success is too low to proceed with the NF session. In some embodiments, the system provides a suggestionto stop the NF treatment if a prediction about success of the subject in a following session is expected to be lower than a target success level.

[0340] According to some exemplary embodiments, the system optionally generates and provides a suggestion to modify the NF, at block 424. In some embodiments, the system provides the suggestion to modify at least one parameter of the NF treatment, at block 424, based on the determined success of the subject and / or based on the determined state of the subject. In some embodiments, the system provides a suggestion to modify the NF if a prediction about success of the subject in a following session is expected to be lower than a target success level.

[0341] In some embodiments, the at least one parameter comprises at least one of, a duration of a NF session, time between NF sessions, type of sensory feedback interface presented to the subject, and / or difficulty and / or complexity of the sensory feedback interface.

[0342] According to some exemplary embodiments, the system optionally generates and provides a suggestion to communicate with the subject, at block 426. In some embodiments, the system provides instructions to communicate with the subject, at block 426, based on the determined success of the subject and / or based on the determined state of the subject. In some embodiments, the suggestion provided includes at least one specific discussion topic, and / or at least one discussion scenario. Optionally, the suggestion includes discussing a cognitive or a mental task applied by the subject. Optionally, the suggestion includes a suggestion to the subject to replace or modify the task he applied. In some embodiments, a suggestion to the subject to replace or modify a task is based on determining that a success of the subject in modifying activity of the brain target during a current NF session or during a NF session that ended is lower than a target success.

[0343] According to some exemplary embodiments, the system optionally generates and provides a suggestion to combine the NF treatment with at least one additional treatment, at block 428. In some embodiments, the system provides the suggestion to combine the NF treatment with at least one additional treatment, at block 428, based on the determined success of the subject and / or based on the determined state of the subject. In some embodiments, the at least one additional treatment comprises a drug treatment, a behavioral treatment, Cognitive behavioral therapy (CBT) and / or psychotherapy.

[0344] According to some exemplary embodiments, the system generates and provides a suggestion to combine the NF treatment with at least one additional treatment, when a success of the subject in a following NF session is expected to be lower than a target success.

[0345] According to some exemplary embodiments, the system optionally generates and provides a suggestion for a subject, for example a trainee, action, at block 429. In some embodiments, the system generates and provides the suggestion to the HCP and / or to the subject. In someembodiments, the suggestion comprises a suggestion to modify a mental strategy, to select a different mental strategy, and / or to perform a physical and / or a mental activity before, during and / or after completing a NF session. In some embodiments, a physical activity comprises, breathing in a specific pattern and any other relaxing and / or attention focusing activity.

[0346] According to some exemplary embodiments, the system optionally initiates a new NF session, at block 430.

[0347] Reference is now made to fig. 4B depicting actions performed by a HCP, for example a supervisor of the NF treatment before, during and / or after NF treatment, and optionally based on indications delivered by a system, according to some exemplary embodiments of the invention. In some embodiments, a supervisor includes a subject that monitors and / or controls a NF treatment, for example NF training delivered to a subject.

[0348] According to some exemplary embodiments, a supervisor of the NF treatment prepares the subject at block 460. In some embodiments, the supervisor delivers instructions to the subject and / or couples one or more electrodes to the subject body, for example to the subject head. Alternatively or optionally, the supervisor electrically connects one or more electrodes already coupled to the subject body, to a NF system, for example to a control unit of the system. Additionally, the supervisor receives information form the subject and inserts the received information to the system memory.

[0349] According to some exemplary embodiments, the supervisor initiates the NF treatment, at block 462. In some embodiments, the supervisor initiates at least one session of the NF treatment at block 462. In some embodiments, the supervisor initiates the NF treatment by delivery of an input signal to the NF system. Optionally, prior to initiating the NF treatment, the supervisor selected a NF protocol from the system memory. Alternatively, the supervisor modifies at least one parameter of an existing NF protocol according to information received form the patient and / or information about the patient. In some embodiments, the supervisor selects a NF protocol and / or modifies the at least one parameter of an existing NF protocol based on indications received from the NF system, for example recommendations and / or instructions. In some embodiments, the subject is located at a separate room from a room of the supervisor, when undergoing the NF treatment.

[0350] According to some exemplary embodiments, during and / or following the NF session, a supervisor receives information about subject performance, at block 464. In some embodiments, the information is received from the NF system, and is optionally in the form of at least one human detectable indication, for example a visual and / or an audio indication. In some embodiments, the information comprises a human detectable indication regarding performance of the subject during the NF session.According to some exemplary embodiments, during and / or following the NF session, a supervisor optionally receives information about a state of the subject, for example mental or cognitive state, at block 464. In some embodiments, the information is received from the NF system, and is optionally in the form of at least one human detectable indication, for example a visual and / or an audio indication. In some embodiments, the information comprises a human detectable indication regarding the subject state.

[0351] According to some exemplary embodiments, one or more of the indications received at block 464 and 466 comprise suggestions which optionally include instructions to communicate with the subject.

[0352] According to some exemplary embodiments, the supervisor communicates, optionally initiates a discussion, with the subject, at block 468. Optionally, the supervisor communicates with the subject according to a script or a scenario provided by the NF system. In some embodiments, for example in case at least one of the indications received at block 464 and 466 is received during a NF session, the supervisor pauses the NF session to communicate with the subject at block 468. Alternatively, the supervisor communicates with subject at the end of the NF session, prior to a following NF session and / or in a beginning of a following NF session.

[0353] According to some exemplary embodiments, during the discussion with the subject, the supervisor relates to one or more suggestions provided by the system. In some embodiments, the supervisor advises the subject to modify a mental strategy the subject applies during NF or to select a different mental strategy. Alternatively or additionally, the supervisor discusses with the subject at least one biopsychosocial factor identified by the system as a reason for low performance, or low success, of the subject in at least one NF session. Alternatively or additionally, the supervisor discusses with the subject ways to maintain or improve subject performance or success in at least one additional NF session, optionally based on suggestions, for example suggestion indications, received from the system.

[0354] According to some exemplary embodiments, the supervisor optionally stops the NF treatment, at block 470. In some embodiments, the supervisor stops the NF treatment if the success level of the subject is not sufficient for continuing with the NF treatment in order to reach a desired, for example a target, goal of the NF treatment. Additionally or optionally, the supervisor stops the NF treatment if the subject state, for example subject mental and / or cognitive state, does not allow to continue with the NF treatment. In some embodiments, the supervisor optionally stops the NF treatment based on one or more of the indications received at block 464 and 466.

[0355] According to some exemplary embodiments, the supervisor optionally modifies at least one parameter of the NF treatment, at block 472. In some embodiments, the supervisor modifies at leastone parameter of the NF treatment if the success level of the subject is not sufficient to reach a desired goal of the NF treatment, for example if the success level of the subject is lower or is sub-optimal compared to a target success level, needed in order to reach the desired goal of the NF treatment. Additionally or optionally, the supervisor modifies the at least one parameter if the state of the subject, for example mental or cognitive state is not an optimal state, for example is a sub optimal state, for reaching the desired goal of the NF treatment. In some embodiments, the at least one NF treatment parameter comprises at least one of, duration of a NF session, time between consecutive NF sessions, type and / or content of a sensory feedback signal provided to the subject. In some embodiments, the supervisor optionally modifies the at least one parameter of the NF treatment based on one or more of the indications received at blocks 464 and 466, optionally based on or according to instructions and / or suggestion provided in the received indications.

[0356] According to some exemplary embodiments, the supervisor continues with delivery of the NF treatment at block 474, optionally using at least one modified parameter of the NF treatment.

[0357] Exemplary generating subject-related observations based on self-modulation of activity of at least one brain target

[0358] Reference is now made to fig. 4C, depicting a process for generating observations and suggestions, based on ability of the subject to self-modify brain activity, for example brain activity of at least one brain target, in a desired direction (up or down) relative to baseline brain activity, according to some exemplary embodiments of the invention.

[0359] According to some exemplary embodiments, at least part of the process described in fig. 4C is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0360] According to some exemplary embodiments, a NF process, for example a NF treatment for treating a clinical condition of the subject and / or for attenuating or alleviating at least one symptom of the clinical condition, includes at least one treatment session, or two or more treatment sessions, for example 2,3,4,5,6,7,8,9,10,11,12,13,14,15, or any higher number of treatment sessions. In some embodiments, the NF treatment includes an interval of at least 1 hour, for example at least 2 hours, at least 5 hours, at least 12 hours, at least 24 hours, at least 48 hours, or any intermediate, smaller or larger number of hours between two consecutive NF treatment sessions.

[0361] According to some exemplary embodiments, each treatment session comprises at least one or two or more, active NF sessions, in which the subject undergoing the NF treatment process is instructed to try and modulate an activity of at least one brain region or at least one brain network ina target direction, for example to upregulate or to downregulate the activity. Alternatively or additionally, during the active NF sessions the subject is instructed to try and modulate a sensory interface presented to the subject, for example a visual and / or an audio interface, in a target way. In some embodiments, during the active NF sessions signals are recorded from the subject body, for example from the subject brain, and are used to determine activity or modulation of activity of the at least one brain region or the at least one brain network.

[0362] According to some exemplary embodiments, a duration of a NF treatment session or of an active NF session is between 1 minute and 120 minutes, for example between 1 minute and 90 minutes, between 1 minute and 60 minutes, between 1 minute and 30 minutes, between 1 minute and 15 minutes, or any intermediate, shorter or longer time period. In some embodiments, a NF treatment session comprises at least one active NF session in which the subject, for example trainee receives a feedback signal modified according to activity of at least one brain target, and at least one session before and / or after the active NF session, where the subject is exposed to a signal, for example a static sensory signal or to a dynamic sensory signal modified independently from the activity of the at least one brain target.

[0363] According to some exemplary embodiments, a NF treatment session is initiated, at block 476. In some embodiments, the NF treatment session is initiated by coupling one or more electrodes to a head of a subject.

[0364] According to some exemplary embodiments, EEG signals recordings is initiated at block 480. In some embodiments, a model is used on the recorded EEG signals, in order to generate indications of activity of the at least one brain target, for example at least one brain region or the at least one brain network, at block 482. In some embodiments, the recorded EEG signals are processed using a mathematical model, for example an electrical finger print (EFP), to generate the indication of activity, for example as described in International Patent Application Publication Number WO2012104853A2, entitled “method and system for use in monitoring neural activity in a subject's brain” incorporated herein as a reference in its entirety.

[0365] According to some exemplary embodiments, the EFP is a mathematical model correlating one or more EEG signals recorded from a subject brain with one or more blood oxygen-level dependent (BOLD) functional magnetic resonance imaging (fMRI) signals from the brain target, thereby allowing to measure activity, for example BOLD activity of the brain target based only on EEG signals and an EFP of the brain target.

[0366] According to some exemplary embodiments, baseline activity level of the at least one brain region and / or network is determined, at block 484. In some embodiments, the baseline activity is determined based on EEG signals recorded while the subject is not engaged with cognitive taskand / or is presented with a neutral sensory interface designed not to affect the activation of the at least one brain region or network. Alternatively or additionally, the subject is instructed to close his eyes when recording EEG signals for establishment of an activity baseline. In some embodiments, the baseline activity is determined based on EEG signals, for example baseline EEG signals, recorded during a baseline portion of the NF treatment session. In some embodiments, the baseline activity is determined according to activity indications generated based on the recorded baseline EEG signals.

[0367] According to some exemplary embodiments, active NF is initiated at block 486. In some embodiments, during active NF, the subject is presented with a sensory interface, and is instructed to try and change the presented sensory interface in a desired way. In some embodiments, the subject is instructed to apply at least one cognitive task, for example a specific or a non-specific cognitive task, that when applied by the subject would change the sensory interface in the desired way. In some embodiments, the presentation of the sensory interface is controlled and modified according to the activity indications generated based on the EEG signals recorded during active NF from the subject. In some embodiments, the sensory interface is modified based on the activity or modulation of activity of the at least one brain region or the at lets one brain network.

[0368] According to some exemplary embodiments, a brain activity indication indicating an activity of the at least one brain region or activity of the at least one brain network during active NF, is generated at block 488. In some embodiments, the brain activity indication is generated by applying a model, optionally a model that is specific to the brain region and / or the network, on EEG signals recorded during active NF. An example of a model, for example an EFP is described in International Patent Application Publication Number WO2012104853A2, entitled “method and system for use in monitoring neural activity in a subject's brain” incorporated herein as a reference in its entirety. In some embodiments, the brain activity indication is at least one signal or at least one measurement.

[0369] According to some exemplary embodiments, the brain activity indication is generated continuously, for example in intervals smaller than 10 seconds, smaller than 5 seconds, smaller than 1 second, smaller than 0.5 second, smaller than 0.1 second, or any intermediate, smaller or larger value, optionally during an active NF session in which an interface, for example a sensory interface is modified according to the generated brain activity indication or changes thereof.

[0370] According to some exemplary embodiments, at least one time window in which activity is modulated, optionally self-modulated, in a desired direction, is identified in the generated activity indication, at block 490. In some embodiments, the at least one time window is identified during the NF session or when completing an active NF session. In some embodiments, during the at least onetime window the activity of the at least one brain region or the at least one network is modulated, for example upregulated or downregulated, relative to a baseline activity previously determined at block 484. In some embodiments, the activity of the at least one brain region or the at least one brain network is self-modulated by the subject during the at least one identified time window, for example by performing at least one task, for example a cognitive or a motor task. In some embodiments, a cognitive task comprises a mental task.

[0371] For example, in some embodiments, in a NF treatment process for treating a subject diagnosed with post-traumatic stress disorder (PTSD), the subject is trained to downregulate an activity of an Amygdala, or an Amygdala-related brain region and / or an Amygdala-related brain network, during the identified time window activity of the amygdala brain region is actively downregulated below a baseline activity of the amygdala brain region, as determined at block 484.

[0372] According to some exemplary embodiments, an activity modulation success score, for example a regulation score is calculated at block 494. In some embodiments, the activity modulation success score is calculated at block 494 based on the activity level of the at least one brain region or the at least one brain network during the identified time window and the duration of the time window.

[0373] According to some exemplary embodiments, a relation between the calculated score and a stored reference value is determined, at block 495. In some embodiments, the stored reference value comprises a measure of central tendency of an activity modulation success score measured in a group of subjects, optionally having similar characteristics as the subject characteristics, for example similar age, gender, clinical condition, mental state, and / or drug regime. Alternatively or additionally, the stored reference value comprises a previously calculated score for the same subject.

[0374] According to some exemplary embodiments, an indication is generated at block 496. In some embodiments, the indication is an indication regarding success of the subject in the active NF session. Alternatively or additionally, the generated indication is an indication regarding performance of the subject. In some embodiments, the indication is generated based on the relation determined at block 495. In some embodiments, the indication is a human detectable indication, for example an audio and / or a visual indication. In some embodiments, the indication is generated based on at least one of, a decrease or increase in a current success score compared to a central tendency measure of a target reference score, optionally measured for a group of subjects. Alternatively or additionally, the indication is generated based on at least one of a drop or a sharp increase in a current success score relative to a success score measured previously for the same subject. In some embodiments, the indication is generated using at least one algorithm, model,formula or a lookup table stored in a memory of the system, for example a memory of a control unit, or a memory of a device in communication with the control unit via a communication circuitry, for example as shown in figs. 2A and 2B. It should be understood that the term memory refers to any type of memory located in a control unit or in a device that is in communication with the control unit, for example as described in figs. 2A and 2B.

[0375] According to some exemplary embodiments, a subject-related observation or an indication thereof, is generated at block 497. In some embodiments, the subject-related observation score is generated based on the activity modulation score calculated at block 494. Alternatively or additionally, the subject-related observation is generated based on the relation between the calculated score and a reference value, determined at block 495. In some embodiments, the subject-related observation comprises information about the subject state, a prediction for an ability of the subject to succeed in at least one session of the NF, information regarding performance of the subject in one or more NF sessions, reasons for subject performance in one or more previously conducted NF sessions and / or for predicted performance in one or more additional NF sessions.

[0376] In some embodiments, the subject-related observation is generated at block 497 using at least one model, formula, and / or algorithm configured to generate the observation or indication thereof based on the calculated activity modulation score and / or based on the determined relation between the calculated score and at least one reference. Alternatively or additionally, the subject-related observation is generated at block 497 using a table, for example a look up table or a hash table mapping the calculated scores to one or more or a plurality of observations. In some embodiments, the table maps ranges of the calculated scores different observations. In some embodiments, each of the different ranges of calculated scores is mapped to a different observation. Alternatively, two or more different ranges of calculated scores are mapped to the same observation. Optionally, a model, for example a machine learning model is used to generate subject-related observations regarding one or more future sessions. For example, observations regarding performance of the subject in one or more following NF sessions.

[0377] Alternatively or additionally, the subject-related observation is optionally generated at block 497 using a lookup table, correlating activity modulation success scores and / or determined relations between a calculated score and a reference, and subject-related observations.

[0378] According to some exemplary embodiments, the subject related observation comprises information about at least one biopsychosocial factor optionally affecting subject performance during the active NF session. Alternatively or additionally, the subject related observation comprises information about the subject experience, for example the subject experience in interacting with the system and / or with the treatment protocol. In some embodiments, theobservation about subject experience comprises information about a mental strategy applied by the subject when trying to modulate a feedback signal, for example a sensory interface, for example whether the mental strategy used by the subject is optimal or sub-optimal. Alternatively or additionally, the observation about the subject experience comprises information about whether or not the subject was able to follow instructions during the NF session, for example instructions provided by the system and / or instructions provided by a HCP. Alternatively or additionally, the subject related observation comprises a prediction of performance or success of the subject in at least one additional NF session or in at least one additional active NF session.

[0379] According to some exemplary embodiments, at least one suggestion or an indication thereof, is produced at block 498. In some embodiments, the suggestion comprises a suggestion for subject-HCP interaction. In some embodiments, the at least on suggestion is produced based on one or more of the observations generated at block 497. In some embodiments, the at least one suggestion comprises information about setting of one or more parameter of an interaction between the subject and a HCP. Alternatively or additionally, the at least one suggestion comprises at least one suggestion for modifying one or more parameter of the interaction. In some embodiments, the one or more parameter comprises at least one of, duration of the interaction, interaction schedule, content of the interaction for example topics to be discussed during the interaction, and / or participants in the interaction.

[0380] Alternatively or additionally, the suggestion comprises a suggestion for a subject action. For example, the suggestion comprises a suggestion for the subject to modify or replace a mental strategy he used in a previous NF session, and / or to perform an exercise before and / or during the NF session. In some embodiments, the exercise comprises a mental or a motoric exercise, optionally configured to increase subject attention and / or focus. Alternatively, the exercise is configured to decrease subject stress and / or anxiety. Optionally, the suggestion comprises a suggestion for the subject to administer at least one drug prior to initiating the NF session.

[0381] Alternatively or additionally, the suggestion comprises a suggestion to discuss with the subject one or more issues related to the observation generated at block 497, related to the subject state, related to at least one of, to the subject performance and / or to the subject experience in the at least one completed active NF session, and / or related to a predicted performance and / or a predicted experience of the subject in at least one additional active NF session or in at least one additional session of the NF treatment.

[0382] In some embodiments, the at least one suggestion is produced at block 498 using at least one model, formula, and / or algorithm configured to generate the at least one suggestion or indicationthereof based on the generated subject-related observation. Alternatively or additionally, the at least one suggestion is produced at block 498 using a table, for example a look up

[0383] Alternatively or additionally, the at least one suggestion is optionally generated at block 498 using a lookup table, correlating subject-related observations, and suggestions.

[0384] According to some exemplary embodiments, the suggestion or an indication thereof is delivered, at block 499. In some embodiments, the suggestion is delivered to the subject and / or to a HCP, for example a supervisor of the NF treatment. Alternatively, the suggestion is delivered and stored in a remote device in communication or that is part of the system. In some embodiments, the suggestion is delivered during an ongoing NF session, at an end of a NF session, prior to initiating an additional NF session and / or in a beginning of an additional NF session.

[0385] Exemplary use case

[0386] According to some exemplary embodiments, a system for delivery of a NF treatment, for example a NF process, to a subject is used for both delivery of the NF treatment and for processing information gathered during the treatment. Optionally, the system comprises two separate systems, a first system for delivery of NF and a second system for generating observations and suggestions. Optionally, the first system is in communication with the second system. Alternatively, the system comprises two different devices, a first device for delivery of NF and a second device for generating observations and for producing suggestions. Optionally, the first device is in communication with the second device.

[0387] In some embodiments, the system processes and analyzed the received information in order to determine performance of the subject with the NF treatment and optionally to determine a state, for example a mental state of the subject. In some embodiments, insights generated by the system with regard to the subject performance and optionally the subject state are provided to a HCP, in the form of an indication, for example a human detectable indication. Optionally, the system also receives information from the HCP following feedback received from the subject, for example during discussions performed with the HCP. In some embodiments, the insights are generated by the system based on the information gathered by the system during the treatment, for example with regard to the performance of the subject, and based on the information received from the HCP.

[0388] Reference is now made to fig. 4D depicting a process for generating indications and a treatment summary by a system based on information collected by the system during at least one NF treatment session, and based on information received from a HCP before, during and / or prior to the at least one NF treatment session, according to some exemplary embodiments of the invention.According to some exemplary embodiments, a subject 401, for example a patient performs a NF treatment 403 using a system 405. In some embodiments, the subject 401 is diagnosed with a mental disorder or suffers from at least one symptom of a mental disorder. In some embodiments, the mental disorder comprises a stress disorder, for example PTSD. In some embodiments, the mental disorder comprises depression, MDD, and SUD. In some embodiments, the subject is diagnosed with the mental disorder according to guidelines of the Diagnostic and Statistical Manual of Mental Disorders, and / or according to guidelines of the American Psychiatric Association.

[0389] According to some exemplary embodiments, data 407 is received during NF treatment. In some embodiments, the data 407 comprises signals recorded from the subject for example by at least one detector, for example an electrode or a sensor, coupled to the subject body, for example at least one EEG electrode coupled to the subject head. Alternatively or additionally, the data 407 comprises signals received from an optic sensor, for example a camera that optionally monitors subject body movement and / or body posture.

[0390] According to some exemplary embodiments, the NF system 405 analyzes the data 407, and generates one or more observations 409, which include observations regarding performance of the subject during at least one session of the NF treatment 403, observations about causes for subject performance during at least one session of the the NF treatment and / or observations regarding a state of the subject 401.

[0391] According to some exemplary embodiments, the system 405 generates at least one indication 411, based on the one or more observations 409. In some embodiments, the indication 411 is a human detectable indication. In some embodiments, the indication 411 reflects the generated one or more observations 409.

[0392] In some embodiments, the indication 411 is optionally delivered to a healthcare professional (HCP). Alternatively or additionally, the generated indication 411 is stored in a database or in a memory of the system 405, and is optionally included in a treatment summary 419.

[0393] According to some exemplary embodiments, the system 405 generates the observations 409 after one or more sessions or after each session of the NF treatment. Alternatively or additionally, the system 405 generates the observations 409 after one or more active NF sessions included in a NF treatment session. Alternatively or additionally, the system 405 generates the indications at an end of the NF treatment 403, for example after completing all planned NF treatment sessions included in a NF treatment 403.

[0394] According to some exemplary embodiments, before, during and / or after a NF treatment 403, or at least one session thereof, a HCP 415, which is optionally a physician or a therapist monitoring the subject during the NF treatment 403 or treats the subject, receives feedback 413 from the subject401. In some embodiments, the feedback 413 is received during discussions with the subject 401 or using one or more questionnaires filled by the subject 401. Alternatively, the HCP 415 receives feedback 413 from the subject by visually observing the subject 401 behavior before, during and / or after the NF treatment 403 or at least one session thereof, for example before, during and / or after an active NF session of the NF treatment 403 performed by the subject 401.

[0395] According to some exemplary embodiments, the HCP 415 determines a subject state 417, for example an emotional state, a cognitive state, and / or a mental state of the subject based on the received feedback 413. Alternatively or additionally, the HCP 415 determines the subject state 417, for example an emotional state, a cognitive state, and / or a mental state of the subject based on observations, for example visual observations of the subject before, during and / or after at least one NF treatment session.

[0396] According to some exemplary embodiments, the HCP 415 provides input to the NF system 405 with information about the subject state 417, optionally using a user interface of a device that is in communication with the system, for example a computer, a mobile device, a cellular device, a terminal. Optionally, the HCP 415 provides an input using a software program, for example an application, stored in a memory of the device, that is in communication with system 405 and is optionally used to deliver indications generated by the system 405 and / or to provide input to the system 405.

[0397] According to some exemplary embodiments, the NF system 405 generates a treatment summary indication 419. In some embodiments, the NF system generates the treatment summary indication 419 based on the observations 409 and / or the subject state 417. In some embodiments, the treatment summary indication 419 is generated based on objective data generated by the system 405, optionally including the observations 409, and subjective data generated by the HCP 415, optionally including the subject state 417.

[0398] According to some exemplary embodiments, the NF system 405 generates the treatment summary indication 419 after and / or during at least one session of the NF treatment 403. Alternatively or additionally, the NF system 405 generates the treatment summary indication 419 after completion of the NF treatment 403, for example after completion of all the planned sessions of the NF treatment 403.

[0399] According to some exemplary embodiments, the treatment summary indication 419 comprises at least one of, information related to at least one session of the NF treatment 403, for example information about a length and / or intensity and / or difficulty level of at least one NF session, information about the observations 409, for example information about possible causes leading to a specific interaction between the subject 401 and the NF system 405, information aboutpossible causes leading to a performance of the subject 401 in the NF treatment 403, suggestions for subject-HCP interaction, for example topics and / or issues for discussion during a meeting between the subject and the HCP, information about the subject state 417, medical and / or clinical history of the subject, and / or results of at least one exam performed by the subject before, during and / or following at least one session of the NF treatment 403, for example results of at least one questionnaire.

[0400] According to some exemplary embodiments, the system 405 generates a human detectable indication 421 with the treatment summary 419, and delivers the indication 421 to the HCP 415, during and / or following at least one NF treatment session of the NF treatment 403, after completion of planned sessions of the NF treatment 403 and / or prior to at least one additional session of the NF treatment 403.

[0401] Exemplary general process for generating observations and suggestions

[0402] Reference is now made to fig. 4E, depicting a general process for generating at least one observation and for producing at least one suggestion for interaction between a subject and a HCP, based on the observation, according to some exemplary embodiments of the invention.

[0403] According to some exemplary embodiments, at least part of the process described in fig. 4E is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0404] According to some exemplary embodiments, a treatment, for example a biofeedback procedure is delivered to a subject at block 425. In some embodiments, at least one session of the biofeedback treatment is delivered to the subject. In some embodiments, during the biofeedback session, the subject is trained to modify a feedback signal indicating activity of the subject body, in a desired direction, for example downregulate the signal or upregulate the signal. In some embodiments, the signal indicates measurable physiological activity of the subject, for example heart activity, heart rate, breathing, blood pressure, brain activity.

[0405] According to some exemplary embodiments, at least one physiological parameter is measured at block 427. In some embodiments, the at least one physiological parameter is measured using at least one detector, for example at least one electrode and / or at least one sensor. In some embodiments, measurements of the at least one physiological parameter or changes thereof are optionally used to generate a feedback signal, for example a feedback signal of body activity presented to the subject. In some embodiments, the feedback signal presented to the subject is modified online, for example with a time difference shorter than 1 minute, shorter than 30 seconds,shorter than 10 seconds, shorter than 1 second, or any intermediate, smaller or larger time duration between measurement of the at least one physiological parameter and modification of the feedback signal, according to measurements of the at least one physiological parameter.

[0406] According to some exemplary embodiments, a score is calculated at block 429. In some embodiments, the score is calculated based on the measurements of the at least one physiological parameter, measured at block 427. In some embodiments, the score indicates a success of the subject to cause a desired, for example a target, change in the feedback signal during at least one session of the biofeedback procedure. Alternatively or additionally, the score indicates a success of the subject to cause a target change in the measurements of the physiological parameter during at least one session of the biofeedback procedure. In some embodiments, a target change comprises a target change in direction of the measurements and / or feedback signal, for example if a goal of the biofeedback procedure is to teach the subject to generate a predetermined increase in the feedback signal and / or the measurements, then the score indicates an ability of the subject to generate the predetermined increase. Alternatively, if a goal of the biofeedback procedure is to teach the subject to generate a predetermined decrease in the feedback signal and / or the measurements, then the score indicates an ability of the subject to generate the predetermined decrease.

[0407] According to some exemplary embodiments, at least one observation is generated at block 431. In some embodiments, the at least one observation is generated based on the measurements measured at block 423 and / or the score calculated at block 429. In some embodiments, generating the at least one observation comprises generating an indication of the at least one observation. In some embodiments, the at least one observation comprises information regarding a state of the subject, for example a state of the subject while performing the biofeedback procedure. Alternatively or additionally, the at least one observation comprises information about an ability of the subject to succeed in achieving a goal of the biofeedback procedure during at least one additional session of the biofeedback procedure, for example an ability of the subject to generate a target modulation of the feedback signal and / or of the measurements of the physiological parameter in at least one additional session of the biofeedback treatment.

[0408] According to some exemplary embodiments, optionally, generating at least one observation comprises generating at least one observation or an indication thereof about the subject mental state, at block 433. In some embodiments, the at least one mental state observation or indication comprises information about a mental state of the subject while performing the biofeedback procedure and / or when the physiological parameter is measured at block 427.

[0409] According to some exemplary embodiments, optionally, generating at least one observation comprises generating at least one observation or an indication thereof about at least onebiopsychosocial factor related to the subject, at block 435. In some embodiments, the at least one biopsychosocial factor comprises at least one of, a subject-related biological factor, a subject-related social factor and / or a subject-related psychological factor. In some embodiments, a subject-related biological factor comprises at least one of, physical health of the subject, genetic vulnerabilities of the subject, and effect of drugs on the subject. In some embodiments, a subject-related social factor comprises at least one of, social interactions of the subject with peers, family circumstances, and / or family relationship. In some embodiments, a subject-related psychological factor comprises at least one of, physical health, mental health, resilience of the subject, coping skills, social skills, family relationships, and / or self-esteem.

[0410] According to some exemplary embodiments, the at least one generated observation, for example an observation regarding subject state (mental state, cognitive state and / or functional state), and / or an observation regarding at least one biopsychosocial factor, includes information that explains subject performance in at least one previous biofeedback session, for example a session in which measurements were taken at block 427 and / or information predicting subject performance in at least one additional session.

[0411] According to some exemplary embodiments, at least one suggestion, for example a suggestion for interaction with the subject, for example a suggestion for interaction between the subject and a HCP, or an indication thereof, is produced at block 437. In some embodiments, the at least one suggestion comprises a suggestion for setting at least one parameter of a subject HCP interaction, for example a meeting between the HCP and the subject, or a suggestion for modifying at least one parameter of the meeting. In some embodiments, the meeting comprises a discussion between the subject and the HCP.

[0412] According to some exemplary embodiments, the at least one suggestion is produced based on the generated observations. Alternatively or additionally, the at least one suggestion is produced based on the score calculated at block 429 and / or the measurements measured at block 427.

[0413] According to some exemplary embodiments, a parameter of a meeting comprises at least one of, a meeting length, when is the meeting going to take place, a meeting content, one or more topics to be discussed during the meeting, participants in the meeting, and / or number of participants in the meeting.

[0414] According to some exemplary embodiments, the at least one suggestion of the indication thereof, is delivered at block 439. In some embodiments, the at least one suggestion is delivered as a human detectable indication to the HCP or to at least one different HCP. In some embodiments, the at least one suggestion is delivered to the HCP at an end of a biofeedback session or between two consecutive biofeedback sessions, optionally to assist the HCP in establishing a strongerconnection with the subject. Optionally or additionally, the at least one suggestion is delivered to the HCP prior to beginning at least one additional biofeedback session or at a beginning of the at least one biofeedback session.

[0415] According to some exemplary embodiments, the process described in fig. 4E is performed by the system 201 shown in fig. 2A. Alternatively, the delivering of the biofeedback procedure is performed by a first system or device, and blocks 427, 429, 431, 433, 435, 437 and 439 are performed by a second different system or device, for example system 201,

[0416] Exemplary general process for generating observations and / or suggestions following NF According to some exemplary embodiments, a subject, for example a subject diagnosed with a mental disorder and / or suffers from at least one symptom of a mental disorder, undergoes a NF treatment. In some embodiments, the subject participates in at least one session of the NF treatment, in which the subject is instructed to modify a feedback signal delivered to the subject to reach a target feedback signal. In some embodiments, the feedback signal is generated based on measurements performed from the subject nervous system, for example from the subject brain. In some embodiments, the measurements indicate activity of at least one brain target, for example activity of at least one brain region, at least one brain network which include at least two brain regions, and / or activity of at least one information flow pathway in the brain between two or more brain regions.

[0417] According to some exemplary embodiments, a goal of the NF treatment session is to reach a target improvement in an ability of the subject to modify the feedback signal towards the target feedback signal, thereby teaching the subject to modulate activity of the at least one brain target towards a target activity level of the brain target. In some embodiments, teaching the subject to modulate activity of the at least one brain target comprises teaching the subject to downregulate activity of the at least one brain target, for example teaching a subject diagnosed with a stress disorder, optionally post-traumatic stress disorder (PTSD) to downregulate activity of an amygdala related brain target. In some embodiments, teaching the subject to modulate activity of the at least one brain target comprises teaching the subject to upregulate activity of the at least one brain target, for example teaching a subject diagnosed with depression, to upregulate activity of one or more brain targets related to the reward system, or to upregulate activity of the reward system.

[0418] According to some exemplary embodiments, the system delivering the NF is configured to process measurements performed during the at least one NF session, and generate at least one observation, for example at least one observation indication with information on the subject, based on the processed measurements. Additionally, the system is configured to produce and deliver oneor more suggestions to a HCP treating the subject how to improve an interaction between the HCP and the subject in order to increase an efficacy of an overall treatment provided to the subject and / or in order to increase an efficacy of the NF delivered to the subject.

[0419] A potential advantage of generating observations and / or suggestions by a system based on measurements, may be that the process for generating the observations and / or suggestions is objective, repetitive and / or is improvable, for example when using for the improvement large datasets, and is not directly affected by the HCP subjective point of view and opinion.

[0420] Reference is now made to fig. 4F depicting a process for generating observations and / or suggestions based on measurements taken during a NF treatment, according to some exemplary embodiments of the invention.

[0421] According to some exemplary embodiments, at least part of the process described in fig. 4F is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0422] According to some exemplary embodiments, NF treatment is delivered to a subject, for example a subject diagnosed with a disorder, at block 447. In some embodiments, the disorder comprises a mental disorder, a cognitive disorder, a behavioral disorder and / or a functional disorder. In some embodiments, a cognitive disorder is a disorder that affects, optionally reduces, one or more cognitive abilities of a subject. In some embodiments, a cognitive disorder comprises dementia, for example Alzheimer’s disease. In some embodiments, a functional disorder is a disorder that affects, optionally reduces, one or more functional abilities of the subject. In some embodiments, a behavioral disorder is a disorder that affects, optionally reduces, one or more behavioral abilities of the subject.

[0423] According to some exemplary embodiments, the NF treatment comprises one or more treatment sessions. In some embodiments, in each NF treatment session, and in the NF treatment, the subject is instructed to modify a feedback signal presented to the subject. In some embodiments, the feedback signal is generated and is modified according to activity and / or changes thereof of at least one brain target, thereby the subject is trained to modify the activity of the at least one brain target, for example in a desired direction.

[0424] According to some exemplary embodiments, at least one goal of the NF treatment, for example at least one goal of the NF treatment session is to modify the activity of the at least one brain target to reach a target activity of the at least one brain target. Optionally, the at least one goal is to modify the activity of the at least one brain target in a desired direction, in a desired leveland / or for a desired duration, optionally relative to a reference activity, for example baseline activity, of the at least one brain target.

[0425] According to some exemplary embodiments, at least one EEG signal is recorded from the subject, at block 449. In some embodiments, the EEG signal is recorded from the subject while the subject is actively engaged in active NF during at least one NF treatment session, in which a feedback signal presented to the subject is modified according to the at least one recorded EEG signal, or a modification thereof. In some embodiments, the at least one EEG signal is recorded by at least one electrode coupled to the subject head.

[0426] According to some exemplary embodiments, at least one signal indicating activity of at least one brain target is measured at block 451. In some embodiments, the at least one signal is measured by applying a model, for example an electrical fingerprint (EFP) indicating activity of the at least one brain target, on the at least one recorded EEG signal, for example to identify in the recorded EEG signal, signal portions indicating activity of the at least one brain target. In some embodiments, the EFP indicates activity of the at least one brain target as measured by functional magnetic resonance activity (fMRI), positron emission tomography (PET) or any other imaging device capable of detecting activity of the at least one brain target over a predetermined time period. In some embodiments, the at least one signal is generated using the EFP as described in WO2012104853A2 titled “method and system for use in monitoring neural activity in a subject's brain”, and in WO2021260697A1 titled “Ventral striatum activity”, both are incorporated herein as a reference in their entirety.

[0427] According to some exemplary embodiments, activity of the at least one brain target during NF is monitored at block 453. In some embodiments, the activity of the at least one brain target is monitored based on the activity indicating signal measured at block 453.

[0428] According to some exemplary embodiments, the monitored activity is analyzed at block 455. In some embodiments, analyzing monitored activity comprises analyzing changes in the activity of the at least one brain target, optionally relative to a reference activity, for example baseline activity of the at least one brain target. In some embodiments, the analysis comprises identifying at least one epoch during the monitored activity in which activity of the at least one brain target is regulated by the subject, for example self-regulated, in a desired direction, for example upregulated or downregulated, according to a goal of the NF treatment. In some embodiments, in the at least one identified epoch the activity indicating signal measured at block 453 indicates regulation of activity of the at least one brain target in the desired direction.

[0429] According to some exemplary embodiments, the at least one epoch has a duration that is shorter or equal to the duration of the at least one NF session in which the subject is requested tomodify the feedback signal. In some embodiments, the at least one epoch has a duration between 0.1 second and 10 minutes, for example between 0.1 second and 2 minutes, between 1 second and 1 minutes, between 1 second and 10 seconds, between 1 second and 1 minutes, or any intermediate, shorter or longer time period.

[0430] According to some exemplary embodiments, at least one activity related score is calculated at block 457. In some embodiments, the at least one activity-related score is calculated based on the analysis results. In some embodiments, the score is calculated based on one or more parameters of the activity indicating signal in the at least one identified epoch. In some embodiments, the one or more parameters comprise AUC, average mean, standard deviation, entropy, Z value, covariance, correlation, granger causality, dynamic time wrapping, synchronization likelihood, spectral centroid and flatness. In some embodiments, the calculated score is a central tendency or a dispersion measure of the one or more parameters for two or more epochs identified during the at least one NF session. In some embodiments, the score is calculated based on a difference between the activity indicating signal and a reference activity value, for example baseline activity, during the at least one identified epoch.

[0431] According to some exemplary embodiments, a relation between the calculated score and a reference value is optionally determined at block 459. In some embodiments, the reference value indicates a target activity modulation of the at least one brain target. In some embodiments, the target activity modulation reference value is an expected goal to be achieved by the subject during the at least one NF session. In some embodiments, the determined relation indicates whether or not the subject is able to achieve the goal of the at least one NF session. In some embodiments, the reference value comprises a value indicating a target performance or a target experience of the same subject in one or more past NF sessions and / or a target performance or target experience of the subject in one or more future NF sessions. In some embodiments, the reference value indicates target performance or target experience of a group of trainees / subjects in one or more past NF sessions and / or target performance or target experience of the trainees / subjects in one or more future NF sessions.

[0432] According to some exemplary embodiments, the system generates at least one observation, for example at least one observation indication regarding performance and / or experience of the subject in the NF treatment, at block 461. In some embodiments, the system generates the observation indication based on the relation determined at block 459, and / or based on the activity related score calculated ay block 457. In some embodiments, the performance and / or experience observation indication includes information about the performance and / or experience of the subject during the NF treatment session, for example whether or not the subject was successful inmodulating the activity of the at least one brain target to reach a desired activity level in at least one previous session, and / or whether the subject experience was a target desired experience. Alternatively or additionally, the performance observation indication includes information about a predicted performance and / or a predicted experience of the subject during at least one planned NF treatment session, for example whether or not the subject will succeed to modulate the activity of the at least one brain target to reach a desired activity level during the at least one planned NF treatment session.

[0433] According to some exemplary embodiments, the system optionally generates at least one observation, for example at least one observation indication, regarding a state of the subject, at block 463. In some embodiments, the state of the subject comprises a mental state, and / or a cognitive state of the subject. In some embodiments, the system generates the state observation indication based on the relation determined at block 459, and / or based on the activity related score calculated ay block 457. In some embodiments, the state observation indication includes information about a state of the subject during and optionally prior to performing the NF session.

[0434] According to some exemplary embodiments, the system optionally generates at least one observation, for example at least one observation indication, regarding at least one biopsychosocial factor, at block 463. Optionally, the at least one biopsychosocial factor comprises a factor, for example, a subject-related biological factor, a subject-related social factor and / or a subject-related psychological factor for example, affecting or suspected to affect the subject state. In some embodiments, the system generates the biopsychosocial factor observation indication based on the relation determined at block 459, and / or based on the activity related score calculated ay block 457. In some embodiments, the at least one biopsychosocial factor observation indication comprises information about at least one of, a subject-related biological factor, a subject-related social factor and / or a subject-related psychological factor. In some embodiments, a subject-related biological factor comprises at least one of, physical health of the subject, genetic vulnerabilities of the subject, and effect of drugs on the subject. In some embodiments, a subject-related social factor comprises at least one of, social interactions of the subject with peers, family circumstances, and / or family relationship. In some embodiments, a subject-related psychological factor comprises at least one of, physical health, mental health, resilience of the subject, coping skills, social skills, family relationships, and / or self-esteem.

[0435] According to some exemplary embodiments, the system comprises a list of predetermined observations, and at least one of, a lookup table, a model, an algorithm configured to correlate a score calculated at block 457, brain target activity measured at block 453 and / or a relation determined at block 49 with at least one observation from the list of predetermined observations. Insome embodiments, generating an observation comprises selecting at least one observation from the list of predetermined observations.

[0436] According to some exemplary embodiments, the system produces at least one suggestion, for example a suggestion indication based on the observations generated at blocks 461, 463 and 465, at block 467. Alternatively or additionally, the at least one suggestion is produced based on the relation determined at block 459 and / or based on the activity -related score calculated at block 457. In some embodiments, the at least one suggestion indication comprises information about modifying a treatment provided to the subject according to the one or more observations, according to the relation determined at block 459 and / or according to the activity -related score calculated at block 457.

[0437] According to some exemplary embodiments, the produced suggestion includes information about a suggested setting or a suggested modification of a HCP-subject interaction, for example a meeting between the HCP and the subject. According to some exemplary embodiments, the information includes at least one suggestion regarding at least one parameter of the meeting, for example meeting duration, topics to be discussed during the meeting, meeting location, meeting schedule, type of participants in the meeting, number of participants, and / or time between the meeting and at least one NF session.

[0438] Alternatively or additionally, the produced suggesting includes information about a suggested setting of at least one treatment or a suggested modification of at least one treatment, for example, a NF treatment, a drug treatment, a CBT treatment, and / or a psychotherapy treatment.

[0439] According to some exemplary embodiments, the system optionally delivers the observation, at block 469. In some embodiments, the system delivers at least one human detectable indication of the at least one observation generated at block 461, 463 and / or 465. In some embodiments, the system optionally delivers the observation, at an end of a NF session, during the NF session, between two NF sessions, prior to a beginning of a NF session and / or at a beginning of the NF session. In some embodiments, the system delivers the observation to a HCP using a user interface of the system, or via a communication circuitry communicating with a remote device of the HCP.

[0440] According to some exemplary embodiments, the system optionally delivers the suggestion, at block 471. In some embodiments, the system delivers at least one human detectable indication of the at least one suggestion produced at block 467. In some embodiments, the system optionally delivers the suggestion, at an end of a NF session, during the NF session, between two NF sessions, prior to a beginning of a NF session and / or at a beginning of the NF session. In some embodiments, the system delivers the suggestion to the HCP using a user interface of the system, or via a communication circuitry communicating with a remote device of the HCP.According to some exemplary embodiments, the one or more observation indications and / or the one or more suggestion indications is generated using at least one large language model (LLM). In some embodiments, the at least one LLM model is used to generate personalized feedback, for example personalized observations and / or suggestions. Optionally, the feedback comprises a cognitive behavioral therapy (CBT) inspired feedback. In some embodiments, additional measures and biomarkers are incorporated to guide massaging personalization, optionally at the end of each treatment session, for example to support the HCP in leading the subject through the treatment, for example training, process.

[0441] According to some exemplary embodiments, the at least one observation indication generated by the system, for example by a control circuitry of the system, comprises information that the subject has performed a sub-optimal cognitive task during the at least one NF treatment session. In some embodiments, performing a sub-optimal cognitive task comprises applying, for example performing at least one cognitive task, that achieved performance of the subject in the neurofeedback that is below an optimal, for example a desired or a target performance. For example, in a case where the subject applies or performs a cognitive task that is not sufficient for achieving self-modulation of at least one brain target in a target direction and in a target level, resulting with a lower performance of the subject in the neurofeedback session compared to a reference or compared to a desired performance. In some embodiments, if the observation indication includes information that the cognitive task performed by the subject is sub-optimal, the system, for example the control circuitry generates a suggestion indication with a suggestion to modify the cognitive task, or to replace the cognitive task with a different cognitive task.

[0442] Exemplary brain activity scores

[0443] Reference is now made to figs. 5A-5F, depicting changes in a brain activity signal during an active NF session that are used for calculation of a brain target activity-related score, according to some exemplary embodiments of the invention.

[0444] According to some exemplary embodiments, figs. 5A-5F showing changes in signal 502 indicating changes in brain activity of at least one brain target, while a subject self-modulates the brain activity, for example during an active neurofeedback session. In some embodiments, the changes in brain activity are measured with respect to a baseline activity 504 of the at least one brain target measured before or after the active neurofeedback session, while the subject is at rest, and is optionally presented with a neutral sensory interface. In some embodiments, a neutral sensory interface comprises an audio and / or visual interface designed or selected not to affect activity of the at least one brain region and / or the activity of the at least one brain network. In someembodiments, the neutral sensory interface is a passive interface, that does not provide feedback regarding an activity of the at least one brain target.

[0445] According to some exemplary embodiments, figs. 5A-5C show changes in a brain activity signal, where an aim of the NF treatment is to teach the subject to self-downregulate activity of the at least one brain target. In some embodiments, during the active neurofeedback session, the subject is instructed to apply a task or a strategy while receiving online a feedback signal in order to modify the feedback signal in a way indicating downregulation of the brain target.

[0446] According to some exemplary embodiments, as described at block 455, the activity of the brain signal is analyzed, in order to calculate a brain activity score which represents downregulation of the bran target. In some embodiments, for example as shown in figs. 5A-5C, the brain activity signal measured during the active NF session, between TO and T9, is divided into epochs which indicate down-regulation of brain activity. In some embodiments, for example as shown in fig. 5A, an epoch between T1 and T3, and an epoch between T5 and T7, indicate time periods in which the activity signal 502 is downregulated from a maximal activity level (at Tl, T5) to a minimal activity level (at T3 and T7), relative to baseline activity 504 . In some embodiments, a regulation score is calculated based on values of at least one parameter calculated for a relative difference between the activity signal and the baseline activity in these epochs in which the activity signal is downregulated from the maximal activity level to the minimal activity level. In some embodiments, the parameter comprises at least one of, Pearson correlation coefficient, Granger causality, Dynamic Time Warping, NF spectral centroid, First Peak to peak score, NF Kurtosis, and / or NF entropy. In some embodiments, the regulation score indicates an ability of the subject to regulate an activity of the brain target according to a goal of the NF treatment, for example to downregulate or upregulate the activity of the brain target.

[0447] According to some exemplary embodiments, for example as shown in fig. 5B, epochs in which the activity signal 502 is lower than baseline 504 are used for calculating the regulation score, for example an epoch between T2 and T4 and an epoch between T6 and T8.

[0448] According to some exemplary embodiments, for example as shown in fig. 5C, epochs in which the activity signal is lower than baseline 504 and is downregulated between baseline activity level, at T2 and T6 and a minimal activity level at T3 and T7, are used for calculating the regulation score.

[0449] According to some exemplary embodiments, for example as shown in figs. 5D-5F, in case a goal of the NF is to teach a subject to upregulate activity of a brain target, the regulation score is based on epochs in which the activity signal 502 is higher than baseline activity and / or is increased from a minimal activity level.According to some exemplary embodiments, for example as shown in fig. 5D, the activity score is calculated based on epochs in which the activity signal 502 is higher than baseline activity 504, for example an epoch between TO and T2, an epoch between T4 and T6, and an epoch between T8 and T9. In some embodiments, for example as shown in fig. 5E, the regulation score is calculated based on epochs in which the activity signal increases between a minimal point of activity level and up to a point of maximal activity, for example an epoch between TO and Tl, and epoch between T3 and T5, and an epoch between T7 and T9. In some embodiments, for example as shown in fig. 5F, a regulation score is calculated based on epochs in which the activity 502 is higher than baseline and is upregulated between the baseline activity and a maximal activity level, for example an epoch between TO and Tl, an epoch between T4 and T5, and an epoch between T8 and T9.

[0450] Exemplary predicting performance

[0451] According to some exemplary embodiments, the system is configured to predict performance of a subject currently performing active NF or that completed an active NF session, in a following active NF session. In some embodiments, the system predicts performance or experience of a subject completed a NF treatment session, in at least one additional NF treatment session, for example in the following NF treatment session.

[0452] According to some exemplary embodiments, predicting performance or experience in a following NF treatment session comprises predicting an ability of the subject to self-modulate activity of at least one brain target in a desired direction, and / or in a desired modulation level.

[0453] According to some exemplary embodiments, during a first NF treatment session, for example during a first active NF session, the subject applies at least one mental task to selfmodulate activity of at least one first brain target. In some embodiments, the system predicts an ability of the subject to self-modulate the activity of the at least one first brain target in a second NF treatment session, for example in a second active NF of the same NF session or in at least one additional NF session. In some embodiments, the system predicts the ability of the subject to self-modulate the activity of at least one brain target in a second NF treatment session, based on the performance of the subject in the first NF treatment session.

[0454] According to some exemplary embodiments, the system prediction is based on measured changes in activity of a brain target during the first NF session, for example while a subject applies at least one mental strategy. In some embodiments, the prediction comprises a prediction whether or not the subject will be able to self-modulate the activity of the brain target during a second consecutive NF treatment session in a similar way to the self-modulation during the first NFtreatment session, in a better way indicating an increase in a performance of the subject, or in a worst way indicating a decrease in the subject performance.

[0455] Reference is now made to fig. 5G, depicting predicting subject performance in a future NF session, for example in a future NF treatment or training session, and / or in a future active NF session, according to some exemplary embodiments of the invention.

[0456] According to some exemplary embodiments, at least part of the process described in fig. 5G is optionally performed by the system shown in figs. 2A or 2B, or one or more of the system components, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0457] According to some exemplary embodiments, EEG is recorded during a first NF session, at block 520. In some embodiments, the EEG is recorded by one or more electrodes positioned on a subject scalp. In some embodiments, EEG is recorded, for example as described at block 449 in fig.

[0458] 4F. In some embodiments, the EEG is recorded from a subject while the subject undergoes active NF to try and modify a feedback signal delivered to the subject. In some embodiments, the feedback signal indicates activity of at least one brain target, for example a brain region, a subcortical brain region, a network, an amygdala brain region, a network associated or comprising the amygdala brain region, a salience network, a network of the reward system and / or a brain region of the reward system.

[0459] According to some exemplary embodiments, an indicator of activity of the at least one brain target is measured at block 522. In some embodiments, the activity indicator is measured from the EEG signals recorded at block 520 using a model, for example a signature for the activity of the brain region. In some embodiments, the model is a mathematical model correlating EEG signals having specific parameters with activity of the brain target, for example with BOLD activity of the at least one brain target as measured in functional MRI. In some embodiments, an example of an activity indicator is signal 502 shown in figs. 5A-5F.

[0460] According to some exemplary embodiments, the system determines modulation of brain target activity in first NF session, at block 524. In some embodiments, the system determines the modulation in activity of the brain target based on the indicator measured in block 522. In some embodiments, determining activity modulation comprises determining ability of the subject to modulate the activity of the brain target in a desired direction and optionally in a desired level, based on the indicator measured in block 522.

[0461] According to some exemplary embodiments, the system optionally predicts changes in the brain target activity during a future NF session, at block 526. In some embodiments, the systempredicts future changes in a following NF session based on the determined modulation of target activity in a previous NF session, for example in a first session.

[0462] According to some exemplary embodiments, the system predicts performance of the subject in a future NF session, at block 528. In some embodiments, predicting performance comprises predicting ability of the subject to self-modulate activity of the brain target in a future session, for example in a consecutive NF session.

[0463] According to some exemplary embodiments, the system generates an observation about the performance prediction, at block 530. In some embodiments, the observation comprises at least one reason for the predicted performance. For example, the observation includes information about at least one biopsychosocial factor affecting the predicted performance. Alternatively or additionally, the observation includes information about a state of the subject, for example a mental and / or a cognitive state of the subject that may lead to the predicted performance.

[0464] According to some exemplary embodiments, the observation is generated at bock 530 using a lookup table, correlating predicted performance with one or more observations from a list of predetermined observations.

[0465] According to some exemplary embodiments, the generated observation is optionally delivered to a HCP and / or to the subject performing the NF.

[0466] According to some exemplary embodiments, the system produces at least one suggestion at block 532. In some embodiments, the system produces at least one suggestion based on the observation generated at block 530 and / or based on the performance of the subject predicted at block 528. In some embodiments, the suggestion includes information on one or more ways to maintain or improve subject performance in the future NF session. For example, ways to maintain or increase an ability of the subject to self-modulate activity of the brain target in the future session. In some embodiments, the suggestion includes suggestion of one or more topics to discuss with the subject prior to initiating the future NF session, for example a consecutive NF session. Alternatively or additionally, the suggestion includes a suggestion for the subject to perform a mental, cognitive and / or a motoric activity of the body, prior to initiating the future NF session.

[0467] According to some exemplary embodiments, the suggestion is generated at bock 532 using a lookup table, correlating predicted performance and / or at least one observation with one or more suggestions from a list of predetermined suggestions.

[0468] Reference is now made to fig. 5H depicting applying a prediction model to predict subject performance in a future NF session, according to some exemplary embodiments of the invention.

[0469] According to some exemplary embodiments, at least part of the process described in fig. 5H is optionally performed by the system shown in figs. 2A or 2B, or one or more of the systemcomponents, for example the control circuitry 205 or the control circuitry 206, the memory 207 or memory 208, and the user interface 209 or user interface 210.

[0470] According to some exemplary embodiments, an activity indicator of a brain target is provided at block 534. In some embodiments, the activity indicator is stored in a memory of a control unit or in a memory of device in communication with the control unit. In some embodiments, the activity indicator is a signal indicating activity or changes thereof of at least one specific brain target, for example signal 502 shown in figs. 5A-5F. In some embodiments, the activity indicator is generated, for example as described at block 522 of fig. 5G. In some embodiments, the activity indicator comprises an EFP signal or changes thereof.

[0471] In some embodiments, the activity indicator is a signal having a time duration of at least 1 millisecond, for example at least 1 second, at least 1 minute, at least 2 minutes, at least 5 minutes, at least 10 minutes, at least 30 minutes, at least 40 minutes, or any intermediate, shorter or longer time period. In some embodiments, the signal indicates an activity of at least one brain target or changes thereof, during a baseline portion of a NF treatment session, where the subject is not exposed to a sensory interface or to a dynamic feedback signal that changes according to activity of the brain target. Alternatively or additionally, the signal indicates the activity of the brain target when the subject is exposed to a sensory interface and / or when delivering a dynamic feedback signal that changes according to brain target activity, to the subject.

[0472] According to some exemplary embodiments, the provided indicator is divided into epochs, at block 536. In some embodiments, the indicator signal provided at block 534 is divided into one or more epochs, each of at least 1 seconds, for example epochs of at least 40 seconds, at least 1 minute, at least 90 seconds, at least 2 minutes, or any intermediate, shorter or longer epochs time. In some embodiments, a length of the epochs is identical. Alternatively, the length of at least some of the epochs varies.

[0473] In some embodiments, the provided indicator is divided into selected epochs, selected based on a trend of the indicator signal that is according to a target of the NF treatment. For example, in case the NF treatment is configured to teach a subject to downregulate activity of the brain target, the provided signal is divided into epochs in which the activity signal indicates absolute downregulation of the brain target activity or relative downregulation of the brain target activity that is relative to a predetermined baseline or reference activity of the brain target. Alternatively, in case the NF treatment is configured to teach a subject to upregulate activity of the brain target, the provided signal is divided into epochs in which the activity signal indicates absolute upregulation of the brain target activity or upregulation of the brain target activity that is relative to a predetermined baseline or reference activity of the brain target.According to some exemplary embodiments, one or more selected parameters of the activity indicator signal are measured at block 538. In some embodiments, the one or more selected parameters are measured in each of the epochs. In some embodiments, the one or more selected parameters are parameters used in a prediction model for predicting subject performance in a future session.

[0474] According to some exemplary embodiments, the one or more parameters comprise at least one of, Pearson correlation coefficient, Granger causality, Dynamic Time Warping, NF spectral centroid, First Peak to peak score, NF Kurtosis, and / or NF entropy.

[0475] Optionally, one or more additional parameters are measured. In some embodiments, the one or more additional parameters comprise parameters not related to the activity indicator, for example heart rate, heart rate variability, skin conductance, and Electromyography (EMG). In some embodiments, the one or more additional parameters are measured during the NF session, optionally simultaneously with EEG measurements.

[0476] According to some exemplary embodiments, a prediction model is applied at block 540. In some embodiments, the parameters measured at block 538 are used as input data for the prediction model.

[0477] In some embodiments, the model is applied on the values of the measured parameters and optionally in addition on values of the additional parameters, for example on values of collected parameters. Optionally, the model is adjusted for a specific subject or a specific group of subjects, for example a specific patient or group of patients.

[0478] According to some exemplary embodiments, the prediction model comprises weights of one or more of the parameters. In some embodiments, the model is used to calculate a relation between two or more extracted parameters values. Alternatively or additionally, the model is used to calculate a relation between values of at least one parameter and a reference value.

[0479] According to some exemplary embodiments, a prediction score is calculated at block 542. In some embodiments, the prediction score is an output of the model, applied at block 540 using the measured parameter values. In some embodiments, the prediction score is calculated based on a calculated relation between at least two parameter values or based on a calculated relation between values of at least one parameter and a reference value. Alternatively or additionally, the prediction score is calculated based on the different weights of the one or more parameters.

[0480] According to some exemplary embodiments, the prediction score is a score predicting subject ability to self-modulate activity of a brain target in a future NF session, as described at block 528 of fig. 5G. Alternatively, the predicted subject ability to self-modulate activity of brain target in a future NF session is determined based on a relation between the prediction scorecalculated at block 542 and a reference value, for example a reference value indicating a target or a desired modulation level.

[0481] According to some exemplary embodiments, a target modulation level comprises a reduction of the brain target activity in the next NF session, in at least 5%, in at least 10%, in at least 25%, in at least 30%, in at least 50% or any intermediate, smaller or larger percentage value when the subject is exposed to a sensory stimulus, relative to the reduction of the brain target activity achieved in a previous NF session or in a current NF session, achieved by the subject.

[0482] According to some exemplary embodiments, if the overall goal of the NF treatment is to teach the subject how to upregulate activity of the brain target, then a target modulation level comprises an increase in brain target activity in at least 5%, in at least 10%, in at least 25%, in at least 30%, in at least 50% or any intermediate, smaller or larger percentage value when the subject is exposed to a sensory stimulus, relative to the increase of the brain target activity achieved in a previous NF session or in a current NF session, achieved by the subject.

[0483] According to some exemplary embodiments, a goal of the overall NF treatment is to reach an increase in self-modulation performance of the subject, of at least 1%, of at least 5%, of at least 10%, or any intermediate, smaller or larger percentage value, when comparing self-modulation performance of the subject in a NF treatment session to a previous NF treatment session.

[0484] According to some exemplary embodiments, if the self-modulation performance of the subject in the next NF treatment session is predicted to be lower than a desired performance, the system generates at least one observation, for example an indication, regarding the predicted low performance. In some embodiments, the observation comprises one or more reasons for the predicted low performance. In some embodiments, the system generates the at least one observation by selecting the observation from a predetermined list of observations, optionally using a lookup table. In some embodiments, the lookup table correlates a predicted level of low performance with one or more observations from the list of observations.

[0485] Alternatively, the system is configured to generate at least one observation if the selfmodulation performance of the subject in the next NF treatment session is predicted to be higher than a desired performance. In some embodiments, the generated observation comprises information regarding the expected increase in performance in the next NF treatment session.

[0486] According to some exemplary embodiments, the system produces at least one suggestion according to the generated observation, for example by selecting the at least one suggestion from a list of predetermined suggestions, optionally using a lookup table. In some embodiments, the lookup table correlated one or more observations with one or more suggestions.According to some exemplary embodiments, if the observation indicates that the subject performance in the next NF treatment session is expected to be lower than a desired performance, then the suggestions includes information on how to increase subject performance, for example by discussing with the subject one or more topics, by modifying one or more parameters of the NF treatment and / or by requesting the subject to perform at least one task.

[0487] According to some exemplary embodiments, if the observation indicates that the subject performance in the next NF session is expected to be similar or higher than a desired performance, then the suggestion includes information on how to maintain subject performance and / or how to give positive feedback to the subject.

[0488] In some embodiments, the system delivers the generated observation and / or suggestion to a HCP and / or to the subject, optionally using a user interface of a control unit and / or a user interface of a device, for example a remote device in communication with the control unit or is part of the system.

[0489] Exemplary NF process

[0490] Reference is now made to fig. 6, depicting a NF process, for example a NF training process, according to some exemplary embodiments of the invention.

[0491] According to some exemplary embodiments, a NF process 602, for example a NF treatment, also termed herein as NF training, comprises a plurality of spaced-apart periodic NF sessions 604, optionally followed by one or more booster session delivered to the subject after completion of the NF sessions 604. Optionally, the NF process 602 is divided into a beginning portion 606 of the NF process which includes up to the first 5 sessions, for example the first 1 to 5 sessions, the MID portion 608 of the NF process which includes up to 11 sessions, for example sessions 5-11, and an END portion 610 of a NF process, which includes up to 5 of the last NF sessions of the NF process 602.

[0492] According to some exemplary embodiments, after completion of the END portion 610, which includes the last one or more sessions of the NF process 602, the subject is optionally invited to one or more boosters sessions 612. In some embodiments, the boosters 612 are performed in a facility, for example a medical or a therapy facility, for example a clinic. Alternatively or additionally, one or more of the boosters 612 are performed at the subject home. In some embodiments, during a single booster session, the subject performs an active NF session, in which an interface presented to the subject changes according to the subject brain activity. In some embodiments, a single booster session that can have a similar duration length, a shorter durationlength or a longer duration length compared to one or more of the sessions performed during the beginning 606, mid 608 or end 610 phases.

[0493]

[0494] Reference is now made to fig. 7 A, depicting generation of an EFP signal, according to some exemplary embodiments of the invention. In some embodiments, the EFP signal is an indicator of brain target activity or changes thereof. In some embodiments, the generated EFP signal indicates, for example predicts, activity of a specific brain target. It should be noted that although fig. 7A depicts generation of an Amygdala-EFP signal predicting BOLD activity of the Amygdala, using an Amygdala- EFP model, generation of other signals predicting BOLD activity of other brain regions, for example deeply located brain regions, is performed in a similar way using an EFP model that is specific to the brain region.

[0495] According to some exemplary embodiments, during active NF sessions, for example session 482, an interface, for example a dynamic audio / visual interface 704 is displayed to the subject 706. Optionally, the subject 706 is instructed to try and modify dynamic audio / visual interface 704, for example by applying at least one strategy, for example by self-performing at least one cognitive and / or mental task.

[0496] According to some exemplary embodiments, electrical signals are recorded by one or more electrodes 708 positioned on the subject head, optionally, during the display of the dynamic audio / visual interface 704 to the subject 706. In some embodiments, the electrodes, comprise EEG electrodes.

[0497] According to some exemplary embodiments, the NF device measures at least one EEG signal, for example a raw EEG signal 610, from the recorded electrical signals.

[0498] According to some exemplary embodiments, EEG features 712 are extracted from the raw EEG signal 710. In some embodiments, the EEG features comprise frequency bands, and time delays for each electrode. Optionally, the features and intensities are arranged in a matrix.

[0499] According to some exemplary embodiments, the EEG features and their intensities are multiplied by the weights of the EFP model 702, to calculate an EFP signal 714 which indicates a prediction of BOLD-activity of the specific brain region or a specific network. Optionally, the specific brain region is part of the specific brain network.

[0500] According to some exemplary embodiments, the NF device, for example a control circuitry of the NF device is configured to modify at least one parameter of the interface 704 according to changes in the calculated EFP signal 714 In some embodiments, a feedback regarding the activity of the at least one brain region or the at least one brain network is delivered to the subject 706 by the interface 704 modifications. Alternatively or additionally, a feedback regarding the ability of the subject to modulatethe activity of the at least one brain region or the activity of the at least one brain network is delivered to the subject 706 by the interface 704 modifications.

[0501] Exemplary active NF cycle

[0502] Reference is now made to fig. 7B, depicting an active NF cycle process, according to some exemplary embodiments of the invention.

[0503] According to some exemplary embodiments, one or more active NF cycles are performed during a NF treatment session, for example an active NF cycle 482 described in figs. 4C and 4D.

[0504] According to some exemplary embodiments, a global baseline is measured in each active NF cycle or at least one time during a NF treatment session. In some embodiments, in a global baseline measurement stage 720, EEG data is recorded during rest, for example while the subject is presented with a black screen with a white asterisk. Alternatively, the subject is presented with a non-dynamic interface and / or with an interface that is not relevant to the subject mental disorder and / or that cannot trigger one or more symptoms of the mental disorder. In some embodiments, the EEG is then preprocessed to remove noise artifacts. In some embodiments, following noise artifacts removal, a Stockwell transform is applied and its output is resampled, in both the time and frequency domains (to 4 Hz up to 250Hz and 9 to 10 pre-defined frequency bands). In some embodiments, a central tendency measure, for example an average value for each frequency band is calculated and stored for the rest of the NF treatment session, where optionally they are used to center the time-frequency transformed EEG signals during the EFP signal computation.

[0505] According to some exemplary embodiments, after measurements of the global baseline, the subject is presented with a dynamic feedback interface, for example an animated feedback interface, for N times, for example for at least two times. In some embodiments, the subject is presented with the dynamic feedback interface for 3 times, for 4 times, for 5 times, for 6 times, for 7 times, for 8 times, or any larger number of times, repeating cycles of “rest”, when the subject is instructed not to try and modulate the dynamic feedback interface, and “regulate,” where the subject is instructed to try and modulate the dynamic feedback interface, optionally by applying a mental or a cognitive strategy.

[0506] According to some exemplary embodiments, during “rest” phases, for example phase 722, 724 and 728, EEG data is recorded while the subject watches a dynamic feedback interface, which in this phase does not respond or being modified according to changes in the EEG signal, for example EFP signal (i.e. no feedback). Optionally, a local baseline is measured, for example calculated during “rest” phase 722. In some embodiments, the EFP values are computed for this phase by calculating the resampled Stockwell transform, subtracting the average values calculated from the signal acquired during the Global Baseline phase, and multiplying the result by weights of the EFP model, for example EFPmodel 702.

[0507] According to some exemplary embodiments, EFP values are computed in the same way, as described above with respect to “rest” phase 722, during the active feedback phase 726, termed “regulate”. In some embodiments, a change in the calculated EFP signal between “regulate” and “rest” is then calculated using a summary statistics (mean and standard deviation) of the EFP values calculated during “rest” (Local Baseline). In some embodiments, this calculated change in the EFP signal is then reflected to the subject as a change in the dynamic feedback interface, for example the animated audiovisual interface.

[0508] According to some exemplary embodiments, a duration of a global baseline measurement phase 720 is within a range between 5 seconds and 5 minutes, for example in a range between 1 minute and 5 minutes, in a range between 2 minutes and 4 minutes, or any intermediate, shorter or longer time period.

[0509] According to some exemplary embodiments, a duration of a local baseline measurement phase 722, for example “rest” phase 722, is within a range between 5 seconds and 5 minutes, for example in a range between 1 minute and 5 minutes, in a range between 30 seconds and 2 minutes, or any intermediate, shorter or longer time period.

[0510] According to some exemplary embodiments, a duration of an active NF phase 726, is within a range between 5 seconds and 5 minutes, for example in a range between 1 minute and 5 minutes, in a range between 30 seconds and 2 minutes, or any intermediate, shorter or longer time period.

[0511] According to some exemplary embodiments, a duration of a “rest” phase 728, at an end of NF phase 726, is within a range between 5 seconds and 2 minutes, for example in a range between 1 minute and 5 minutes, in a range between 30 seconds and 2 minutes, or any intermediate, shorter or longer time period.

[0512] Reference is now made to fig. 8, depicting exemplary relation between changes in performance scores, for example regulation score, calculated for a subject during a NF session, and observations regarding state of the subject and cause thereof, according to some exemplary embodiments of the invention.

[0513] For example, reasons for a low regulation score, for example success score 802, relative to a reference value, optionally relative to a central tendency measure of scores measured from subjects completing the same number of NF treatment sessions, may be caused due to at least one of, a negative external biopsychosocial trigger affecting the subject (also termed herein as a client in some embodiments), inability of the subject to understand the NF treatment instructions, inability of the subject to find a working mental strategy that when applied modulates the NF sensory interface and / or a specific brain target in a desired direction (upregulate / downregulate), and / or inability of the subject to focus during the NF treatment session. In some embodiments, a low regulation score may indicate a negativeemotional state, for example depression, frustration, and / or apathy. In some embodiments, a negative external biopsychosocial trigger comprises at least one of, sound, sensation, or visual trigger.

[0514] For example, a drop 804 in regulation score relative to a previous regulation score measured for the same subject, optionally in more than 25%, for example more than 30%, more than 50%, or any intermediate, smaller or larger percentage value, may be caused due to a negative external biopsychosocial trigger affecting the subject, inability of the subject to find a working mental strategy that when applied modulates the NF sensory interface and / or a specific brain target in a desired direction (upregulate / downregulate), and / or inability of the subject to focus during the NF treatment session. In some embodiments, a drop 804 in regulation score may indicate a negative emotional state, for example apathy and / or restless.

[0515] For example, a decline 806 in regulation score over two or more NF sessions, may be caused due to inability of the subject to find a working mental strategy that when applied modulates the NF sensory interface and / or a specific brain target in a desired direction (upregulate / downregulate), and / or inability of the subject to focus during the NF treatment session. In some embodiments, a decline 806 in regulation score may indicate a negative emotional state, for example depression of the subject.

[0516] For example, an unstable 808 regulation score during the last 3 or more NF sessions, may be caused due to inability of the subject to focus during the NF treatment session. In some embodiments, the unstable 808 regulation score may indicate a negative emotional state, for example apathy of the subject.

[0517] For example, a stable regulation score with no change (810) during the last 3 or more NF sessions, may be caused due to inability of the subject to find a working mental strategy that when applied modulates the NF sensory interface and / or a specific brain target in a desired direction (upregulate / downregulate). In some embodiments, the stable regulation score may indicate a negative emotional state, for example a useless feeling of the subject.

[0518] For example, an improvement 812 in the regulation score during the last 3 or more NF sessions, may be caused by the ability of the subject to find a working mental strategy, and may indicate a positive mental state of the subject, for example the subject feels hopeful and successful.

[0519] For example, a jump 814 in the regulation score during the last 2 or more NF sessions or a score that is higher 816 relative to a central tendency measure of scores measured from subjects completing the same number of NF treatment sessions, may be caused due to the ability of the subject to find a working mental strategy and / or because the subject received a positive external biopsychological trigger. In some embodiments, the jump in the regulation score may indicate a positive mental state of the subject, for example the subject feels hopeful and successful.

[0520] Exemplary visual display or regulation score

[0521] Reference is now made to figs. 9A depicting a visual display for presenting performance of asubject during NF treatment sessions, according to some exemplary embodiments of the invention.

[0522] According to some exemplary embodiments, a performance of the subject is presented in a graph 902 describing an active regulation score (y-axis), optionally normalized, as measured during one or more NF sessions (x-axis) of a NF treatment. In some embodiments, normalized active regulation scores per each session are presented in the graph. In some embodiments, the graph displays subject progress over time in modifying a sensory interface, for example a dynamic visual interface in a desired way compared to the performance of a group of subjects that performed a similar NF treatment, for example a population of PTSD patients that underwent the same procedure.

[0523] In some embodiments, upper portion 904 of the graph 902 indicates high performance levels, and lower portion 906 indicates low performance levels among a population of subjects having similar characteristics as the subject, for example if the subject is a PTSD patient the population of subjects are PTSD patients. In some embodiments, a middle portion 905 indicates an average performance level of the population.

[0524] In some embodiments, each score of a session is presented as a dot 908 on the graph 902. In some embodiments, a best-fit line of the dots 908 is presented to the subject as an indicator for continues change in the score during the NF treatment. Alternatively an average score of at least 3 last consecutive sessions is calculated and displayed, for example as dot 910, and a change trend connecting dots 910 is displayed as an indicator to the change in the score during the NF treatment. Optionally, a score of the last session is also presented, for example as dot 912.

[0525] A potential advantage of graph 902 displayed to a HCP may be that it allows to present a progress in a subject performance during a NF treatment compared to a performance of a population having similar characteristics, for example clinical characteristics that are similar to the characteristics of the subject.

[0526] Fig. 9B is a visual representation, for example a graph showing overall quality of the way by which a subject performing NF was able to modulate an activity indicator of a brain target, according to some exemplary embodiments of the invention. In some embodiments, the modulation of brain target activity is an indicator for the overall treatment quality delivered to the subject. In some embodiments, the graph is delivered to the subject as an indication, for example a human detectable indication. In some embodiments, the graph shows a likelihood that the treatment is having a desired effect, for example a target effect, on an outcome of the subject.

[0527] According to some exemplary embodiments, the visual representation of the treatment quality is normalized and presented on a scale between 0 and 1, where 0.5 represents a 50% likelihood that the treatment is having an effect, optionally a positive effect, on a subject outcome.The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0528] The term “consisting of’ means “including and limited to”.

[0529] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0530] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0531] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0532] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0533] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0534] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques andprocedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0535] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition

[0536] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0537] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0538] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A system, comprising:a memory, wherein said memory stores measurements or changes thereof of at least one physiological parameter measured during at least one session of a treatment and / or following the at least one treatment session, wherein said measurements indicate a response or changes thereof of the subject body to at least one sensory interface presented to the subject during said at least one treatment session;a user interface configured to generate and deliver at least one human detectable indication; a control circuitry, wherein said control circuitry is configured to:process said measurements to determine performance of said subject in said at least one treatment session;produce at least one suggestion indication according to said determined performance, wherein said at least one suggestion indication comprises information about one or more ways to maintain or improve performance of said subject in at least one additional session of said treatment compared to said determined performance in said at least one treatment session;signal said user interface to generate and deliver at least one human detectable indication with said at least one suggestion indication.

2. A system according to claim 1, wherein said memory stores a group of predetermined suggestion indications, and wherein said control circuitry is configured to produce said at least one suggestion indication by selecting said at least one suggestion indication from said group of predetermined suggestion indications stored in said memory according to said determined performance.

3. A system according to claim 2, wherein said memory stores at least one lookup table, algorithm or formula correlating performance of said subject and at least one suggestion indication of said group of predetermined suggestion indications, and wherein said control circuitry produces said at least one suggestion indication using said at least one lookup table, said algorithm or said formula.

4. A system according to any one of the previous claims, wherein said memory stores at least one large language model (LLM), and wherein said control circuitry produces said at least one suggestion indication using said at least one LLM model.

5. A system according to any one of the previous claims, wherein said control circuitry is configured to generate at least one observation indication with information about performance of said subject in said at least one session and / or with information about predicted performance of the subject in at least one additional NF session, based on said determined performance of said subject, and to produce said at least one suggestion indication based on said generated at least one observation indication.

6. A system according to claim 5, wherein said memory stores a group of predetermined observation indications, and wherein said control circuitry is configured to generate said at least one observation indication by selecting said at least one observation indication from said group of said predetermined observation indications stored in said memory based on said determined performance of said subject.

7. A system according to claim 6, wherein said memory stores at least one lookup table, algorithm or formula correlating determined performance of said subject with at least one observation indication, and wherein said control circuitry is configured to select said at least one observation indication using said at least one lookup table, algorithm or formula.

8. A system according to claim 6, wherein said memory stores at least one large language model (LLM), and wherein said control circuitry generates said at least one observation indication using said at least one LLM model.

9. A system according to any one of claims 5 to 8, wherein said at least one observation indication generated by said control circuitry comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

10. A system according to claim 9, wherein said control circuitry is configured to determine that said performance is lower than a target performance, and to generate said at least one observation indication with information about at least one biopsychosocial factor associated with said determined lower performance.

11. A system according to any one of the previous claims, wherein said measurements comprise measurements of signals from a brain of said subject indicating activity of at least one brain target during said at least one treatment session.

12. A system according to claim 11, wherein said at least one brain target comprises at least one of, at least one brain region, at least one sub-cortical brain region, at least one brain network, an amygdala brain region, at least one brain network including the amygdala brain region, a salience network, a reward system and / or at least one brain region of the reward system.

13. A system according to any one of claims 11 or 12, wherein said control circuitry is configured to process said measurements by dividing said measurements into epochs in which said activity is lower or higher that a reference value, and to determine said performance of said subject based on at least one parameter of said measurements during said epochs.

14. A system according to any one of claims 11 to 13, wherein said treatment comprises a neurofeedback (NF) treatment in which said subject is trained to modify activity of said at least one brain target, wherein said measurements comprise measurements of signals from a subject brain indicating activity of the at least one brain target.

15. A system according to claim 14, wherein said signals comprise electroencephalogram (EEG) signals.

16. A system according to any one of claims 14 or 15, wherein during said NF treatment said subject is trained to modulate activity of said at least one brain target in a target direction by performing at least one cognitive task during said at least one treatment session, and wherein said control circuitry is configured to process said measurements to determine performance of said subject in said at least one treatment session by determining an ability of said subject to modulate said activity of said at least one brain target in said target direction by performing said at least one cognitive task;wherein said control circuitry is configured to calculate a performance score based on said determined ability, and wherein said control circuitry is configured to produce said at least one suggestion based on said calculated performance score.

17. A system according to claim 16, wherein said control circuitry produces said at least one suggestion indication with a suggestion to modify the at least one cognitive task performed by the subject or to perform a different cognitive task, if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

18. A system according to any one of claims 16 or 17, wherein said memory stores information about said at least one cognitive task performed by the subject.

19. A system according to any one of claims 16 to 18, wherein said control circuitry produces said at least one suggestion indication with a suggestion to stop or modify the NF treatment if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

20. A system according to any one of claims 16 to 19, wherein said control circuitry produces said at least one suggestion indication with a suggestion to replace or combine said NF treatment with at least one additional treatment if the calculated performance score indicates that the performance of the subject during the at least one treatment session was lower than a target performance level.

21. A system according to claim 20, wherein said at least one additional treatment comprises at least one of, psychotherapy, cognitive behavioral treatment (CBT) and at least one drug treatment.

22. A system according to any one of claims 14 to 21, wherein said memory stores at least one protocol of said NF treatment, and wherein said system is used to deliver said NF treatment to said subject according to said at least one protocol stored in said memory.

23. A method, comprising:measuring at least one signal indicating activity of at least one brain target during at least one session of a neurofeedback (NF) treatment in which a subject is instructed to modify a sensory interface presented to the subject towards a target sensory interface by performing at least one cognitive task, wherein changes in said sensory interface indicate changes in activity of the at least one brain target;processing said at least one signal;determining performance of said subject during said at least one session based on said processing results;generating based on said determined performance, at least one observation indication with information about performance of said subject in said at least one session and / or with information about expected performance of the subject in at least one additional NF session;producing according to said generated at least one observation indication, at least one suggestion indication with information about one or more ways to improve or to maintain performance of said subject in said at least one additional NF treatment session.

24. A method according to claim 23, wherein said generating comprises generating based on said determined performance, at least one treatment-related observation indication with information about an interaction between the subject and the NF treatment, and wherein said producing comprises producing at least one suggestion indication with information about one or more ways to improve interaction between the subject and the NF treatment.

25. A method according to claim 24, wherein said at least one treatment-related observation comprises information that the subject did not follow instructions of said NF treatment, and wherein said suggestion comprises a suggestion to modify said instructions and / or to repeat delivery of said instructions, before and / or during, said at least one session, or said at least one additional NF session.

26. A method according to any one of claims 24 or 25, wherein said at least one observation indication comprises information that the subject has performed a sub-optimal cognitive task during the at least one NF treatment session, and wherein said at least one suggestion indication comprises a suggestion to modify said cognitive task, or to replace said cognitive task with a different cognitive task.

27. A method according to any one of claims 23 to 26, wherein said at least one observation indication comprises information that the subject performance during the at least one NF treatment session was sub-optimal, and wherein said at least one suggestion indication comprises a suggestion to stop or modify the NF treatment.

28. A method according to any one of claims 23 to 27, wherein said at least one observation indication comprises information that the subject performance during the at least one NF treatment session was sub-optimal, and wherein said at least one suggestion indication comprises a suggestion to replace or to combine said NF treatment with at least one different treatment.

29. A method according to claim 28, wherein said at least one different treatment comprises at least one of, a drug treatment, psychotherapy, and cognitive behavioral treatment (CBT).

30. A method according to any one of claims 23 to 26, wherein said at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

31. The method of any one of claims 23 to 30, wherein said processing comprises identifying in said at least one signal one or more epochs in which the signal indicates a target change in activity of said at least one brain target relative to a reference activity level, measuring one or more parameters of said at least one signal during said one or more epochs, and calculating an activity score of said at least one brain target based on said measurements, wherein said determining performance comprises determining performance of said subject by determining a relation between said calculated activity score and a reference value indicating target activity of said at least one brain target, and wherein said generating at least one observation comprises generating said at least one observation based on said determined relation.

32. The method of any one of claims 23 to 31, wherein said generating at least one observation comprises selecting said at least one observation indication from a group of predetermined observations based on said determined performance.

33. The method of any one of claims 23 to 32, wherein said producing said at least one suggestion indication comprises selecting said at least one suggestion indication from a group of predetermined suggestions.

34. The method of any one of claims 23 to 33, wherein said generating comprises generating said at least one observation using at least one large language model (LLM) based on said determined performance, and / or wherein said producing comprises producing said at least one suggestion indication using at least one large language model (LLM), according to said generated at least one observation indication.

35. The method of any one of claims 23 to 34, comprising delivering said produced at least one suggestion indication to a healthcare provider (HCP) monitoring said treatment and / or to the subject, prior to at least one additional treatment session of said NF and / or in a beginning of said at least one additional treatment session.

36. The method of claim 35, comprising receiving a feedback signal from said healthcare provider and / or from said subject with information about said delivered suggestion following said delivering, and generating at least one different suggestion indication based on said feedback information.

37. The method of any one of claims 23 to 36, comprising:receiving signals recorded from a brain of said subject by at least one electrode; wherein said measuring comprises measuring at least one EEG signal indicating activity of said at least one brain target by processing said received signals using at least one model correlating EEG signals with activity of said at least one brain target.

38. The method of any one of claims 23 to 37, wherein said subject is diagnosed with at least one mental disorder or suffers from at least one symptom of said mental disorder.

39. The method of claim 38, wherein said at least one mental disorder comprises post-traumatic stress disorder (PTSD).

40. The method of any one of claims 38 or 39, wherein said at least one mental disorder comprises at least one of, attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD), depression and / or major depressive disorder (MDD).

41. A method, comprising:receiving measurements of at least one physiological parameter, wherein said measurements indicate a response or changes thereof of the subject body during at least one session of a treatment in which the subject is presented with at least one sensory interface;processing the measurements to determine performance of said subject in said treatment; generating at least one observation indication regarding performance of said subject in said at least one session of said treatment and / or regarding performance of said subject in at least one additional session of said treatment, wherein said at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined performance of said subject or with predicted performance of the subject in at least one additional session of the treatment, wherein said at least one biopsychosocial factor comprises at least one of, a biological factor, a psychological factor, and / or a social factor.

42. The method of claim 41, wherein said generating said at least one observation indication comprises selecting said at least one observation indication from a group of predetermined observation indications using at least one of, a lookup table, an algorithm, a mathematical model, and / or a formula correlating a determined performance with at least one observation indication from said group of predetermined observation indications.

43. The method of any one of claims 41 or 42, wherein said determining comprises determining that said performance is lower relative to a target performance, and wherein said generated at least one observation indication comprises information about at least one biopsychosocial factor associated with said determined lower performance.

44. The method of claim 43, comprising producing at least one suggestion indication with information about one or more ways to improve or maintain performance of said subject in at least one additional session of said treatment, according to said generated at least one observation indication.

45. The method of claim 44, comprising:delivering said at least one suggestion indication to a healthcare provider (HCP) monitoring said treatment prior to at least one additional treatment session of said treatment and / or in a beginning of said at least one additional treatment session.

46. The method of claim 45, wherein said at least one suggestion indication comprises a suggestion of at least one topic for a discussion with the subject.

47. The method of any one of claims 45 or 46, wherein said at least one suggestion indication comprises a suggestion to replace said treatment or to combine said treatment with at least one additional treatment, wherein said at least one additional treatment comprises at least one of, a drug treatment, a neurofeedback treatment, psychotherapy and cognitive behavioral treatment (CBT).

48. The method of any one of claims 45 to 47, wherein said at least one suggestion indication comprises a suggestion for the subject to perform at least one cognitive task prior to or during at least one additional session of said treatment.

49. The method of any one of claims 45 to 48, wherein said at least one suggestion indication comprises a suggestion to administer at least one drug to the subject prior to at least one additional treatment session of said treatment and / or during the at least one additional treatment session.

50. The method of any one of claims 45 to 49, comprising receiving a feedback signal from said HCP and / or from said subject with feedback information about said delivered suggestion following said delivering, and generating at least one different suggestion indication based on said feedback information.

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