Treatment of mental disorders

Abstract

A method for administering a neurofeedback (NF) process to a subject, comprising: educating the subject to modify the activity of at least one specific brain region by administering at least one NF session of therapy, wherein administering at least one NF session of therapy includes presenting the subject with a sensory index, instructing the subject to modify the sensory index by performing a specific activity, monitoring changes in the activity of at least one brain region during the presentation, and providing the subject with feedback signals indicating the monitored changes during the presentation; and administering a maintenance session of the NF process to the subject after the completion of the NF session, wherein the maintenance session includes presenting the subject with a trigger selected to evoke a sensory index used during the NF process session, and instructing the subject to perform a specific activity used during the NF process session in response to the presentation.

Description

Technical Field

[0001] Related Applications This application claims the benefit of priority under 35 USC§119(e) of U.S. Provisional Patent Application No. 63 / 451,015, filed on March 9, 2023, the content of which is hereby incorporated by reference in its entirety.

Background Art

[0002] In some embodiments, the present invention relates to the treatment of mental disorders, and more specifically, to the treatment of mental disorders using biofeedback, such as neurofeedback (NF).

Summary of the Invention

[0003] Examples of some embodiments of the present invention are listed below (one embodiment of the present invention may include features of two or more examples and / or may not include all features of one example).

[0004] Example 1. A method of performing neurofeedback (NF) treatment on a subject, comprising: educating the subject to modify the activity of at least one specific brain region by performing an NF session of the treatment, the performing comprising: presenting a sensory indicator to the subject; instructing the subject to modify the sensory indicator by performing a specific activity; monitoring changes in the activity of the at least one brain region during the presenting; and providing a feedback signal indicating the monitored changes to the subject during the presenting. including educating; The procedure involves administering a maintenance session of the treatment to the subject at least two hours after the education, wherein the maintenance session is configured to induce at least a portion of the NF session in the subject, and the procedure is to administer the treatment. Presenting to the subject an index configured to evoke the sensory index used during the aforementioned education, and In response to the aforementioned presentation, instruct the subject to perform the specific activity used during the aforementioned education, This includes implementing, Methods that include...

[0005] Example 2. The aforementioned education is conducted at the treatment center, and the aforementioned implementation is conducted outside the said center. The method described in Example 1.

[0006] Example 3. The aforementioned treatment center includes a clinic, The method described in Example 2.

[0007] Example 4. The education includes measuring electrical signals from the subject's brain during the education, and the monitoring includes monitoring the changes in the activity of the at least one brain region based on the measured electrical signals. The method described in any one of Examples 1 to 3.

[0008] Example 5. Performing the aforementioned maintenance session does not involve measuring electrical signals from the subject's brain. The method described in any one of Examples 1 to 4.

[0009] Example 6. The aforementioned electrical signals include electroencephalogram (EEG) signals. The method described in Example 4 or 5.

[0010] Example 7. Said educating includes selecting the specific activity from two or more activities used during said education. The method according to any one of Examples 1 to 6.

[0011] Example 8. Said implementing is carried out according to a predetermined schedule of said treatment. The method according to any one of Examples 1 to 7.

[0012] Example 9. including receiving input from the subject after said education, Said implementing is carried out in response to the received input. The method according to any one of Examples 1 to 7.

[0013] Example 10. The input includes information regarding at least one of cognitive difficulties, behavioral difficulties, and / or mental difficulties that the subject is currently experiencing or expects to experience. The method according to Example 9.

[0014] Example 11. including repeating said executing in at least one additional NF session, and said implementing is carried out during an interval period between said at least one NF session and said at least one additional NF session. The method according to any one of Examples 1 to 10.

[0015] Example 12. including transmitting an indicator to a supervisor of the treatment after said implementing of the maintenance session is completed. The method according to any one of Examples 1 to 11.

[0016] Example 13. including diagnosing that the subject has a mental disorder or a brain disorder before said education, and / or identifying that the subject exhibits at least one symptom of said mental disorder or brain disorder before said education. The method according to any one of Examples 1 to 13.

[0017] Example 14. The mental disorder or brain disorder includes stress disorder, post-traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, autism, The method according to Example 13.

[0018] Example 15. Adjusting the timing of performing the educating and / or the performing according to the mental disorder or brain disorder or according to the at least one symptom. The method according to Example 14.

[0019] Example 16. Including modulating the sensory index and / or the specific activity performed by the subject according to the mental disorder or brain disorder or according to the at least one symptom. The method according to Example 14 or 15.

[0020] Example 17. The sensory index includes an auditory index and / or a visual index. The method according to any one of Examples 1 to 16.

[0021] Example 18. A method of performing neurofeedback (NF) treatment on a subject, Educating the subject to modify the activity of at least one specific brain region by performing at least one NF session of the treatment, and the performing is Presenting a sensory index to the subject, Instructing the subject to modify the sensory index by performing a specific activity. During the presentation, monitor the changes in activity of at least one brain region, and During the presentation, provide the subject with a feedback signal indicating the monitored change. This includes educating, Determining the subject's condition at least one hour after the completion of at least one NF session, wherein the subject's condition includes at least one of the subject's mental state, behavioral state, and / or cognitive state. Methods that include...

[0022] Example 19. Depending on the status of the person determined, this includes scheduling at least one additional NF session to repeat the education, The method described in Example 18.

[0023] Example 20. This includes modifying at least one of the sensory indicators, the specific activity, the instructions provided to the subject during the education, and / or the specific activity applied by the subject, in accordance with the determined state. The method described in Example 19.

[0024] Example 21. This includes performing or scheduling maintenance sessions of the NF treatment according to the determined state, The maintenance session includes presenting the subject with indicators configured to evoke the sensory indicators used during the education, and instructing the subject to perform the specific activity used during the education. The method described in any one of Examples 18-20.

[0025] Example 22. This includes sending alert indicators along with information about the status of the person identified, to an expert or remote server. The method described in any one of Examples 18-21.

[0026] Example 23. Depending on the condition of the person determined, the process includes sending a suggestion to the person or a specialist monitoring the treatment, the suggestion including a suggestion to initiate, discontinue, or modify at least one additional treatment. The method described in any one of Examples 18-22.

[0027] Example 24. The aforementioned at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and behavioral therapy. The method described in Example 23.

[0028] Example 25. The aforementioned determination is made based on the results of at least one evaluation questionnaire to determine the status of the subject. The method described in any one of Examples 18-24.

[0029] Example 26. The aforementioned at least one assessment questionnaire may be the Clinical-Administered PTSD Scale for DSM-5 (CAPS-5) and / or a parameter, domain, or derivative of CAPS-5, the PTSD Checklist for DSM-5 (PCL-5) or a derivative thereof, the Patient Health Questionnaire-9 (PHQ-9) or a derivative thereof, the Hamilton Depression Rating Scale or a derivative thereof, the Snaith-Hamilton Pleasure Scale (SHAPS) or a derivative thereof, or the Montgomery-Asberg Depression Rating Scale (MADRS). The following are included: a scale) or a derivative thereof, the Patient Health Questionnaire (PHQ) or a derivative thereof, the Clinical Global Impression (CGI) or a derivative thereof, the ADHD Investigator Symptom Rating Scale (AISRS) or a derivative thereof, the Adult ADHD Self-Report Scale (ASRS) or a derivative thereof, the Attention Variable Test (TOVA) or a derivative thereof, the Patient Health Questionnaire (PHQ) or a derivative thereof, the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) or a derivative thereof, the Mini-Mental State Examination (MMSE) or the Folstein Test or at least one of the following derivatives: The method described in Example 25.

[0030] Example 27. The determination includes determining the subject's condition based on the measurement of at least one physiological parameter, including at least one of heart rate, blood pressure, skin conductivity, eye movement, and pupil dilation. The method described in any one of Examples 18-26.

[0031] Example 28. This includes diagnosing the subject having a mental disorder or brain disorder prior to the education, and / or identifying that the subject exhibits at least one symptom of the mental disorder or brain disorder prior to the education, The method described in any one of the examples 18-27.

[0032] Example 29. The aforementioned mental or brain disorder includes at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The method described in Example 28.

[0033] Example 30. This includes adjusting the timing of the execution of the at least one NF session or the timing of the execution of the at least one additional NF session in accordance with the diagnosed mental disorder or brain disorder, or in accordance with the at least one symptom. The method described in Example 29.

[0034] Example 31. This includes adjusting the sensory indicators and / or the specific activities performed by the subject in accordance with the mental disorder or brain disorder or in accordance with at least one symptom, The method described in Example 29 or 30.

[0035] Example 32. A method of administering neurofeedback (NF) therapy to a subject, Administering the NF therapy to educate the subject to modulate the activity of at least one specific brain region, wherein the administration includes administering two or more sessions of the NF therapy with at least one day interval between them. During the administration of the NF treatment, progress indicators relating to the progress of the subject's ability to modulate activity in at least one specific brain region, and subject status indicators relating to the subject's mental and / or behavioral state, Displaying the aforementioned progress indicator and the aforementioned subject status indicator, Methods that include...

[0036] Example 33. This includes modifying the NF treatment administered to the subject based on the generated progress indicators and / or subject status indicators. The method described in Example 32.

[0037] Example 34. To determine the relationship between the aforementioned progress indicator and the aforementioned subject status indicator, This includes modifying the NF treatment administered to the subject based on the relationship determined above, The method described in Example 32.

[0038] Example 35. Modifying the NF treatment includes at least one of the following: lengthening the NF treatment, shortening the NF treatment, discontinuing the NF treatment, modifying the sensory indicators presented to the subject during the NF treatment, and modifying the instructions provided to the subject during the NF treatment. The method described in Example 33 or 34.

[0039] Example 36. This includes receiving information regarding the mental and / or behavioral state of the subject, The subject status index is generated based on the received information. The method described in any one of Examples 32 to 35.

[0040] Example 37. The received information includes the results of the evaluation questionnaire. The method described in Example 36.

[0041] Example 38. The aforementioned information includes input received from the subject and / or expert, The method described in Example 36 or 37.

[0042] Example 39. The above generation includes generating trends in the progress indicator and trends in the subject status indicator over a specific time period, and the above display includes displaying trends in the progress indicator and trends in the subject status indicator. The method described in any one of Examples 32-38.

[0043] Example 40. The above generation includes generating a predicted progress indicator and a predicted subject status indicator, and the above display includes displaying the trend of the predicted progress indicator and the predicted subject status indicator. The method described in any one of Examples 32 to 39.

[0044] Example 41. The display described above includes displaying the progress indicators and the subject status indicators on a shared visual interface. The method described in any one of the examples 32-40.

[0045] Example 42. A method for identifying electrodes having a target signal quality, The method involves recording electrical signals using at least two electrodes positioned on the subject's body, Identifying the electrode among the at least two electrodes that generates an electrical signal having a selected intensity value, Setting a target range for the selected intensity value, and Identifying at least one additional electrode among the at least two electrodes that generates a signal having an intensity value within the target range of the aforementioned values, Determining that the intensity value of the signal from the identified at least one additional electrode is higher than a predetermined value, Based on the aforementioned determination, the objective is to provide an indicator that can be detected by a human, Methods that include...

[0046] Example 43. If the determination indicates that the intensity value is lower than the predetermined value, the determination includes providing instructions for a method to improve the signal quality from the identified at least one additional electrode. The method described in Example 42.

[0047] Example 44. An NF system for administering NF therapy to a subject, comprising at least one neurofeedback (NF) therapy session and at least one maintenance session, (a) An NF device configured to administer to the subject at least one NF therapy session to educate the subject to modulate the activity of at least one specific brain region, wherein the NF device A memory storing at least one protocol including at least one sensory index and instructions provided to the subject by the NF device, User interface and The control circuit comprises, and the control circuit is To provide the subject with at least one sensory indicator using the user interface, The subject is instructed to adjust the provided at least one visual interface and / or auditory interface by performing at least one activity. Receiving electrical signals from one or more electrodes positioned on the body of the subject, Using the aforementioned electrical signals, measure an indicator of activity in at least one specific brain region or a change in such activity. Providing the subject with a feedback signal during the provision of the at least one first visual interface and / or auditory interface, according to the measured indicators, It is configured to perform NF devices and, (b) A personal device of the subject that communicates directly or indirectly with the NF device and is configured to administer at least one maintenance session of the NF treatment, and is configured to trigger at least a portion of the at least one NF treatment session in the subject, wherein the personal device is A memory storing a maintenance protocol which includes at least one index configured to evoke the sensory index provided by the NF device during the at least one NF treatment session, User interface and A personal device comprising a control circuit, the control circuit being configured to provide, using the user interface, the at least one indicator and instructions to perform the at least one activity to be performed in the at least one NF treatment session, NF system, including

[0048] Example 45. The personal device and the NF device each include a communication circuit, and the personal device communicates directly or indirectly with the NF device using the communication circuit. The system described in Example 44.

[0049] Example 46. The memory of the NF device includes information regarding the status of the subject, The system described in Example 44 or 45.

[0050] Example 47. The control circuit of the NF device generates, selects and / or modifies the at least one sensory index according to the information stored in the memory of the NF device. The system described in Example 46.

[0051] Example 48. The control circuit of the NF device selects or replaces the at least one protocol for training the subject to modulate different specific brain regions according to the stored information. The system described in Example 46 or 47.

[0052] Example 49. The aforementioned information includes information regarding whether the subject has been diagnosed with a mental disorder or brain disorder, or whether he / she is exhibiting symptoms of a mental disorder or brain disorder. The system described in any one of Examples 45-48.

[0053] Example 50. The aforementioned mental or brain disorder includes at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The system described in Example 49.

[0054] Example 51. The at least one index is a modification of the at least one sensory index. The system described in any one of Examples 46-50.

[0055] Example 52. A system comprising a server that communicates with the NF device and the personal device, wherein the server is The NF device has a memory that stores at least one NF treatment protocol, and the at least one protocol stored in the memory of the NF device and the maintenance protocol stored in the memory of the personal device are part of the NF treatment protocol. The system described in Example 44 or 45.

[0056] Example 53. The server stores information regarding the subject's condition and / or information regarding the expectation that the subject will have difficulty with daily activities. The system described in Example 52.

[0057] Example 54. The information relating to the aforementioned condition of the subject includes at least one piece of information relating to mental state, cognitive state, or behavioral state. The system described in Example 53.

[0058] Example 55. The information stored in the server includes information indicating that the subject has been diagnosed with a mental disorder or brain disorder, or is exhibiting symptoms of a mental disorder or brain disorder. The system described in Example 53 or 54.

[0059] Example 56. The aforementioned mental or brain disorder includes at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The system described in Example 55.

[0060] Example 57. The server is configured to perform at least one of the following in accordance with the stored information: rescheduling the at least one NF treatment session and / or the at least one maintenance session; scheduling a meeting with the specialist; and / or providing instructions to the subject via the personal device. The system described in any one of Examples 53-56.

[0061] Example 58. The instructions include performing at least one maintenance session. The system described in Example 57.

[0062] Example 59. The aforementioned instructions include instructions to initiate, modify, or discontinue at least one additional treatment. The system described in Example 57 or 58.

[0063] Example 60. The aforementioned at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and / or behavioral therapy. The system described in Example 59.

[0064] Example 61. The server modifies at least one parameter of the NF treatment session according to the stored information. The system described in any one of Examples 53-60.

[0065] Example 62. The at least one parameter includes the duration of at least one NF session administered by the NF device, the duration of a maintenance session administered by the personal device, the time between the at least one NF session and the at least one maintenance session, the time between two consecutive NF sessions, the number of NF sessions administered to the subject, the number of maintenance sessions administered to the subject, the content of the at least one maintenance session, and the content of the at least one NF session. The system described in Example 61.

[0066] Example 63. The aforementioned information is received from the NF device and / or the personal device. The system described in any one of Examples 53-62.

[0067] Example 64. A system comprising a device for performing neurofeedback (NF) therapy to train the subject to modulate the activity of at least one specific brain region, The device described above, A memory that stores at least one protocol including at least one sensory index and instructions provided to the subject by the NF device, and further includes information about the subject's mental state, User interface and The control circuit comprises, and the control circuit is Using the user interface, the subject is provided with at least one visual interface and / or auditory interface. The subject is instructed to adjust the provided at least one visual and / or auditory interface by performing at least one activity, Receiving electrical signals from one or more electrodes positioned on the body of the subject, Using the aforementioned electrical signals, an indicator relating to the activity of at least one specific brain region or a change in such activity is measured. Depending on the measured indicator, it is configured to provide feedback signals to the subject while providing the at least one first visual interface and / or auditory interface, The control circuit is further configured to generate a progress indicator indicating progress in regulating the activity of at least one brain region of the subject based on the received electrical signal, and a subject state indicator based on the information stored in the memory. system.

[0068] Example 65. The device comprises a supervisor interface functionally coupled to the device and configured to generate human-detectable indicators, the control circuit sending signals to the supervisor interface to display the progress indicators and the subject status indicators. The system described in Example 64.

[0069] Example 66. The control circuit is configured to determine the relationship between the progress indicator and the subject status indicator, and to send a signal to the supervisor interface to display the determined relationship. The system described in Example 65.

[0070] Example 67. The control circuit is configured to generate trends in the changes of the progress indicators and the subject status indicators over a specific period, and / or to predict them, and to send signals to the supervisor interface to display the generated trends in the changes of the progress indicators and the subject mental status indicators, and / or to predict them. The system described in Example 65 or 66.

[0071] Some embodiments of the present invention are shown below (one embodiment of the present invention may include features of two or more examples, or may not include all features of one example).

[0072] Example 1. A method for administering a neurofeedback (NF) process to a subject, The treatment involves educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least one NF session of treatment, and the performance of such treatment is To present sensory indicators to the aforementioned subjects, Instructing the subject to modify the sensory indicators by performing a specific activity, During the presentation, monitor changes in the activity of the at least one brain region or the at least one brain network, and During the presentation, provide the subject with a feedback signal indicating the monitored change. This includes educating, After the completion of the aforementioned NF session, a maintenance session for the aforementioned NF process is conducted for the aforementioned subject, wherein the maintenance session is: Presenting the subject to a trigger selected to evoke the sensory indicator used during the NF process session, and In response to the aforementioned presentation, instruct the subject to perform the specific activity used during the NF process session, This includes implementing, Methods that include...

[0073] Example 2. The aforementioned education is conducted at the treatment center, and the aforementioned implementation is conducted outside the treatment center, and the treatment center includes a clinic. The method described in Example 1.

[0074] Example 3. The education includes measuring electrical signals from the subject's brain during the education, and the monitoring includes monitoring the changes in the activity of the at least one brain region or the at least one brain network based on the measured electrical signals. The method described in Example 1 or 2.

[0075] Example 4. Performing the aforementioned maintenance session does not involve measuring electrical signals from the subject's brain. The method described in Example 3.

[0076] Example 5. The aforementioned electrical signals include electroencephalogram (EEG) signals. The method described in Example 3 or 4.

[0077] Example 6. The educating includes educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least two NF sessions of the NF process with at least a 24-hour interval between them, and the implementing includes implementing the maintenance session on the subject during the interval. The method described in any one of Examples 1 to 5.

[0078] Example 7. This includes receiving input from the subject after the education, The aforementioned actions are performed in response to the received input. The method described in any one of Examples 1 to 5.

[0079] Example 8. The input includes information relating to at least one of the cognitive, behavioral, and / or mental difficulties that the subject is currently experiencing or is expected to experience. The method described in Example 7.

[0080] Example 9. This includes diagnosing the subject having a mental disorder or brain disorder prior to the education, and / or identifying that the subject exhibits at least one symptom of the mental disorder or brain disorder prior to the education. The method described in any one of Examples 1 to 8.

[0081] Example 10. The aforementioned mental or brain disorders include stress disorders, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorders (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The method described in Example 9.

[0082] Example 11. This includes adjusting the timing of the education and / or the implementation of the education, depending on the severity of the mental disorder or the severity of at least one symptom. The method described in Example 10.

[0083] Example 12. The trigger is at least partially similar to the sensory index presented to the subject during the NF session. The method described in any one of Examples 1 to 11.

[0084] Example 13. The aforementioned at least one specific brain region includes the amygdala and / or ventral striatum. The method described in any one of Examples 1 to 12.

[0085] Example 14. The aforementioned at least one specific brain network includes a limbic system network and / or a reward network. The method described in any one of Examples 1 to 13.

[0086] Example 15. A method for administering a neurofeedback (NF) process to a subject, The method involves educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least one NF session of the NF process, wherein the performance is To present sensory indicators to the aforementioned subjects, Instructing the subject to modify the sensory indicators by performing a specific activity, During the presentation, monitor changes in the activity of the at least one brain region or the at least one brain network, and During the presentation, provide the subject with a feedback signal indicating the monitored change. This includes educating, Determining the subject's condition after completing at least one NF session, wherein the subject's condition includes at least one of the subject's mental state, behavioral state, and / or cognitive state. Methods that include...

[0087] Example 16. This includes receiving information regarding the subject's condition after completing at least one NF session, The aforementioned information includes the results of at least one assessment questionnaire, self-reported information, and / or expert input regarding the subject's condition. The method described in Example 15.

[0088] Example 17. The aforementioned at least one assessment questionnaire may be the DSM-5 Clinical Diagnostic Interview Scale for PTSD (CAPS-5) and / or parameters or domains of CAPS-5 or a derivative of CAPS-5, the DSM-5 PTSD Checklist (PCL-5) or a derivative thereof, the Patient Health Questionnaire-9 (PHQ-9) or a derivative thereof, the Hamilton Depression Rating Scale or a derivative thereof, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative thereof, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative thereof, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical General Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Rating Scale (AISRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variable Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Minimal Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The method described in Example 16.

[0089] Example 18. If the determined condition of the subject is worse than the target condition, the arrangement includes scheduling at least one additional NF session to repeat the education. The method described in any one of Examples 15-17.

[0090] Example 19. If the determined condition of the subject is worse than the target condition, the modification of at least one of the sensory indicators, the specific activity, the instructions provided to the subject during the education, and / or the specific activity applied by the subject, according to the determined condition, The method described in any one of Examples 15-18.

[0091] Example 20. This includes performing or scheduling maintenance sessions of the NF treatment according to the determined state, The maintenance session includes presenting the subject with indicators configured to evoke the sensory indicators used during the education, and instructing the subject to perform the specific activity used during the education. The method described in any one of Examples 15-19.

[0092] Example 21. This includes sending a suggestion to the person or a specialist who monitors the treatment, depending on the condition of the person determined above. The aforementioned proposal includes a proposal to initiate, discontinue, or modify at least one additional treatment, wherein the at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and behavioral therapy. The method described in any one of Examples 15-20.

[0093] Example 22. Prior to the education, the subject is diagnosed with a mental disorder or at least one symptom of the mental disorder, The aforementioned mental disorders include at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The method described in any one of Examples 15-21.

[0094] Example 23. A method of administering neurofeedback (NF) therapy to a subject, Administering the NF therapy to educate the subject to modulate the activity of at least one specific brain region, wherein the administration includes administering two or more sessions of the NF therapy with at least one day interval between them. During the administration of the NF treatment, progress indicators relating to the progress of the subject's ability to modulate activity in at least one specific brain region, and subject status indicators relating to the subject's mental and / or behavioral state, Displaying the aforementioned progress indicator and the aforementioned subject status indicator on a shared visual interface, Methods that include...

[0095] Example 24. The aforementioned progress indicators and the aforementioned subject status indicators are displayed side by side in the shared visual interface. The method described in Example 23.

[0096] Example 25. This includes modifying the NF treatment administered to the subject based on the generated progress indicators and / or subject status indicators. The method described in Example 23 or 24.

[0097] Example 26. To determine the correlation between the aforementioned progress indicator and the aforementioned subject status indicator, This includes modifying the NF treatment administered to the subject based on the determined correlation, The method described in any one of Examples 23 to 25.

[0098] Example 27. Generating the progress indicators includes calculating a progress score indicating the progress of the subject and at least one subject status score indicating the status of the subject, and displaying includes displaying the progress score and the at least one subject status score on the shared visual interface. The method described in any one of Examples 23 to 26.

[0099] Example 28. The display includes displaying the changes in the progress score and the changes in the subject status score on the shared visual interface. The method described in Example 27.

[0100] Example 29. The subject's condition includes at least one of the subject's mental state, cognitive state, and functional state. The method described in any one of Examples 23 to 28.

[0101] Example 30. This includes receiving information regarding the status of the subject, The subject status index is generated based on the received information. The method described in any one of Examples 23 to 29.

[0102] Example 31. The received information includes the results of at least one evaluation questionnaire, input received from the subject, and / or input received from the expert. The method described in Example 30.

[0103] Example 32. The above generation includes generating a predicted progress indicator and a predicted subject status indicator, and the above display includes displaying the trend of the predicted progress indicator and the predicted subject status indicator. The method described in any one of Examples 23 to 31.

[0104] Example 33. A method for determining whether an electrode has a target signal quality, The method involves recording electrical signals using at least two electrodes attached to the subject's body, The recorded electrical signals, Identifying at least one of the two electrodes that generates an electrical signal with a target peak-to-peak value, Setting a target range for the identified peak-to-peak values, and If the signal recorded by at least one additional electrode among the at least two electrodes has a peak-to-peak value within the target range of the set value, and the amplitude of the signal is within a predetermined range or higher than a predetermined amplitude value, then it is determined that the signal has the target signal quality. To process by, Based on the aforementioned determination, the objective is to provide an indicator that can be detected by a human, Methods that include...

[0105] Example 34. The recording, processing, determination, and provision are performed before and / or during biofeedback therapy. The method described in Example 33.

[0106] Example 35. An NF system for administering NF therapy to a subject, comprising at least one neurofeedback (NF) therapy session and at least one maintenance session, (a) An NF device configured to administer the subject at least one NF therapy session, wherein the subject is provided with the at least one sensory index along with instructions to adjust the at least one sensory index by performing at least one specific activity during the at least one NF therapy session, (b) A personal device of the subject configured to communicate with the NF device and to administer at least one maintenance session of the NF treatment, wherein the at least one maintenance session is configured to trigger at least a portion of the at least one NF treatment session in the subject, Equipped with, The aforementioned personal device is A memory storing a maintenance protocol which includes at least one trigger configured to evoke the sensory indicators provided by the NF device during the at least one NF treatment session, User interface and A control circuit is provided, wherein the control circuit is configured to provide, using the user interface, the at least one trigger and instructions to perform the at least one specific activity used during the at least one NF therapy session. NF system.

[0107] Example 36. The sensory indicator includes a visual interface and / or an auditory interface, and the trigger is at least partially similar to the visual interface and / or auditory interface. The system described in Example 35.

[0108] Example 37. The memory of the personal device includes a timing schedule for executing the at least one maintenance session, and the control circuit of the personal device is configured to execute the at least one maintenance session according to the timing schedule. The system described in Example 35 or 36.

[0109] Example 38. The NF device is A memory storing at least one NF treatment protocol including at least one sensory index and instructions provided to the subject by the NF device, User interface and The control circuit comprises, and the control circuit is To provide the subject with at least one sensory indicator using the user interface, The subject is instructed to adjust the provided at least one sensory index by performing at least one activity. During the provision of the aforementioned at least one sensory index, electrical signals are received from one or more electrodes attached to the subject's body, Using the aforementioned electrical signals, measure an indicator of the activity of at least one specific brain region or at least one specific brain network, or a change in such activity. By continuously or intermittently modifying the at least one sensory index according to the measured index, a feedback signal indicating the activity of the at least one brain region or the at least one brain network, or a change in such activity, is provided to the subject. It is configured to perform A system described in any one of Examples 35-37.

[0110] Example 39. The control circuit is configured to measure an electroencephalogram (EEG) signal based on the received electrical signal, and the EEG signal indicates the activity or change in the activity of at least one specific brain region or at least one specific brain network. The system described in Example 38.

[0111] Example 40. The aforementioned at least one specific brain region includes at least one subcortical brain region, optionally the at least one subcortical brain region includes the amygdala, ventral striatum, subcortical brain region of the limbic system, and / or subcortical brain region of the reward system. The system described in Example 39.

[0112] Example 41. The memory of the personal device and / or the memory of the NF device stores information about the subject's mental state, and the control circuit of the personal device determines whether to initiate the at least one maintenance session or to determine a timing schedule for initiating the at least one maintenance session based on the information about the mental state. A system described in any one of the examples 38-40.

[0113] Example 42. The control circuit of the personal device is configured to modify the at least one NF maintenance session in accordance with the information relating to the mental state of the subject. The system described in Example 41.

[0114] Example 43. The aforementioned information includes information regarding whether the subject has been diagnosed with a mental disorder or brain disorder, or whether he / she is exhibiting symptoms of a mental disorder or brain disorder. The system described in Example 41 or 42.

[0115] Example 44. The aforementioned mental or brain disorder includes at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The system described in Example 43.

[0116] Example 45. The system includes the aforementioned NF device and a remote device that communicates with the aforementioned personal device, The remote device is A memory having subject-related information including information about the subject's mental state and / or information about the subject's daily activities, A communication circuit configured to communicate with the NF device and the personal device, and The device comprises a control circuit, the control circuit being configured to determine the schedule for at least one additional maintenance session and / or at least one additional NF therapy session according to the stored mental state information, and to signal the communication circuit to provide the schedule to the NF device and / or the personal device. A system described in any one of Examples 41-44.

[0117] Example 46. The control circuit of the remote device determines the schedule, which includes bringing forward the at least one additional maintenance session and / or the at least one additional NF treatment session if the subject-related information indicates that the subject is expected to have difficulty with the daily activities. The system described in Example 45.

[0118] Example 47. The control circuit's determination of the schedule includes delaying the at least one additional maintenance session and / or the at least one additional NF treatment session if the subject-related information indicates a deterioration in the subject's mental state. The system described in Example 45 or 46.

[0119] Example 48. The instructions provided to the subject by the personal device include instructions to apply at least one cognitive activity, which is shown to modulate the provided at least one sensory index when applied by the subject during at least one NF therapy session. A system described in any one of Examples 35-47.

[0120] Example 49. An NF device for administering neurofeedback (NF) therapy to a subject to train the subject to modulate the activity of at least one specific brain region or at least one specific brain network, A memory storing at least one NF protocol, progress indicators indicating the progress of the subject's ability to modulate the activity of at least one specific brain region or at least one specific brain network, and mental state indicators having information about the subject's mental state during NF treatment, A supervisor interface that communicates with the NF device, comprising a supervisor interface that generates and displays at least one visual interface, The NF device is configured to send signals to the supervisor interface to generate and provide the at least one visual interface having the progress indicator and the mental state indicator. system.

[0121] Example 50. The at least one protocol stored in the memory includes at least one sensory indicator and instruction provided to the subject by the NF device, the NF device further comprises a user interface and a control circuit, the control circuit is To provide the subject with at least one sensory indicator using the user interface, Instructing the subject to adjust the provided at least one sensory index by performing at least one activity, Receiving electrical signals from one or more electrodes attached to the head of the subject, Using the aforementioned electrical signals, measure an indicator of the activity of at least one specific brain region or at least one specific brain network, or an indicator of changes in such activity. Providing a feedback signal to the subject during the provision of the at least one sensory index according to the measured index, It is configured to perform the following actions: The control circuit is further configured to generate the progress indicator based on the received electrical signal and to generate the mental state indicator based on the received information relating to the mental state of the subject. The system described in Example 49.

[0122] Example 51. The control circuit is configured to receive an input signal having the information relating to the mental state of the subject, the input signal including the results of at least one assessment questionnaire, self-reported information, and / or input from a professional or supervisor regarding the subject's condition. The system described in Example 50.

[0123] Example 52. The aforementioned at least one assessment questionnaire may be the DSM-5 Clinical Diagnostic Interview Scale for PTSD (CAPS-5) and / or parameters or domains of CAPS-5 or a derivative of CAPS-5, the DSM-5 PTSD Checklist (PCL-5) or a derivative thereof, the Patient Health Questionnaire-9 (PHQ-9) or a derivative thereof, the Hamilton Depression Rating Scale or a derivative thereof, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative thereof, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative thereof, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical General Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Rating Scale (AISRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variable Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Minimal Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The system described in Example 51.

[0124] Example 53. The control circuit is configured to determine the correlation between the progress indicator and the subject's mental state indicator, and to send a signal to the supervisor interface to display the determined correlation. A system described in any one of Examples 50-52.

[0125] Example 54. The control circuit is configured to generate trends in the changes of the progress indicators and the changes in the subject's mental state indicators over a selected period of the NF treatment, and / or to predict them, and to send signals to the supervisor interface to display the generated trends in the changes of the progress indicators and the changes in the subject's mental state indicators, and / or to predict them. A system described in any one of Examples 50-53.

[0126] Example 55. The supervisor interface is configured to display the progress indicator and the mental state indicator side by side in at least one visual interface. A system described in any one of the examples 49-54.

[0127] Example 56. A system comprising an NF device for administering neurofeedback (NF) therapy to a subject to train the subject to modulate the activity of at least one specific brain region or at least one specific brain network, The NF device is A memory storing mental state indices including at least one NF protocol and information about the mental state of the subject during NF treatment, A supervisor interface that communicates with the NF device, comprising a supervisor interface configured to generate and provide indicators detectable by at least one person, The NF device is configured to send signals to the supervisor interface to generate and provide the mental state index along with the index detectable by at least one person. system.

[0128] Example 57. The NF device includes a control circuit, The control circuit is configured to receive an input signal having the information relating to the mental state of the subject, and to generate the mental state index based on the received input signal. The input signal includes the results of at least one assessment questionnaire, self-reported information, and / or input from a professional or supervisor regarding the mental state of the subject. The system described in Example 56.

[0129] Example 58. The aforementioned at least one assessment questionnaire may be the DSM-5 Clinical Diagnostic Interview Scale for PTSD (CAPS-5) and / or parameters or domains of CAPS-5 or a derivative of CAPS-5, the DSM-5 PTSD Checklist (PCL-5) or a derivative thereof, the Patient Health Questionnaire-9 (PHQ-9) or a derivative thereof, the Hamilton Depression Rating Scale or a derivative thereof, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative thereof, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative thereof, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical General Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Rating Scale (AISRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variable Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Minimal Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The system described in Example 57.

[0130] Example 59. The perceptible indicators relating to the mental state of the subject include at least one of the following: a suggestion to reschedule at least one additional NF treatment session, a suggestion to discontinue the NF treatment, and / or a suggestion to modify at least one parameter of the NF treatment protocol. A system described in any one of Examples 56-58.

[0131] Example 60. The perceptible indicators relating to the mental state of the subject include at least one of the following: a proposal to combine the NF treatment with at least one additional treatment, or a proposal to modify the at least one additional treatment. A system described in any one of Examples 56-59.

[0132] Example 61. The aforementioned at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and / or behavioral therapy. The system described in Example 60.

[0133] Example 62. A user interface that generates human-detectable metrics, A memory that stores a predetermined absolute range of signal amplitude values ​​or a threshold value for signal amplitude values, Control circuit and A biofeedback device comprising, The control circuit receives at least one first electrical signal recorded by at least one first electrode and at least one second electrical signal recorded by at least one second electrode. Processing the at least one first electrical signal and the at least one second electrical signal, Following the above process, it is determined that the at least one first electrical signal and the at least one second electrical signal are within the stored predetermined absolute range of peak-to-peak values. Based on the minimum peak-to-peak value of at least one first electrical signal, a relative threshold or relative minimum threshold peak-to-peak value is set. The determination that the at least one second electrical signal has the desired signal quality is made if the peak-to-peak average value of the at least one second electrical signal is within a relative threshold of the peak-to-peak value, or exceeds the relative minimum threshold peak-to-peak value. Based on the result of the determination, a signal is sent to the user interface to generate and provide a human-detectable index, along with information on whether or not the at least one second electrical signal has the desired signal quality. It is configured to perform Biofeedback device.

[0134] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the invention pertains. Similar or equivalent methods and materials to those described herein may be used in the practice or testing of embodiments of the invention, but exemplary methods and / or materials are described below. In case of any conflict, the patent specification, including definitions, shall prevail. In addition, materials, methods, and examples are illustrative and not necessarily intended to be limiting.

[0135] As will be understood by those skilled in the art, some embodiments of the present invention may be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present invention may take the form of complete hardware embodiments, complete software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects commonly referred herein as “circuits,” “modules,” or “systems.” Furthermore, some embodiments of the present invention may take the form of one or more computer program products embodied in a computer-readable medium, having computer-readable program code embodied on the medium. Implementation of some embodiments of the methods and / or systems of the present invention may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. Furthermore, according to the actual equipment and devices of some embodiments of the methods and / or systems of the present invention, some selected tasks may be performed by hardware, software, firmware, and / or in combination thereof (e.g., using an operating system).

[0136] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a set of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to some exemplary embodiments of the method and / or system described herein are performed by a data processor, such as a computing platform for executing a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage devices such as magnetic hard disks and / or removable media for storing instructions and / or data. Network connectivity is also provided as an option. A display device and user input devices such as a keyboard and mouse are also provided as options.

[0137] In some embodiments of the present invention, any combination of one or more computer-readable media may be used. The computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or a suitable combination thereof. More specific examples of computer-readable storage media (non-exclusive list) include an electrical connection with one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or a suitable combination thereof. In this specification, computer-readable storage medium means any tangible medium that may contain or store a program used by or in connection with an instruction execution system, instruction execution apparatus, or instruction execution device.

[0138] A computer-readable signal medium may include, for example, a propagated data signal incorporating computer-readable program code, either in the baseband or as part of a carrier wave. Such propagated signals can take any of a variety of forms, including electromagnetic, optical, or a suitable combination thereof. A computer-readable signal medium may be any computer-readable medium, not a computer-readable storage medium, that can communicate, propagate, or transport programs used by or connected to an instruction execution system, instruction execution unit, or instruction execution device.

[0139] Program code and / or data embodied in a computer-readable medium may be transmitted using an appropriate medium, such as wireless, wire, fiber optic cable, RF, or any combination thereof.

[0140] Computer program code for performing the operation of some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, and C++, and conventional procedural programming languages ​​such as the "C" programming language. The program code may be executed entirely on the user's computer as a standalone software package, partially on the user's computer, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or wide area network (WAN), or it may be connected to an external computer (for example, via the Internet using an Internet service provider).

[0141] Some embodiments of the present invention may be described below with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It should be understood that each block in a flowchart and / or block diagram, and each combination of blocks in a flowchart and / or block diagram, are executable by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device and executed as instructions executed via the processor of the computer or other programmable data processing device to form means for realizing the functions / operations specified in the flowchart and / or block diagram or blocks.

[0142] These computer program instructions may be stored on a computer-readable medium that can notify a computer, other programmable data processing device, or other device to perform a specific action, and the instructions stored on the computer-readable medium may result in a product containing instructions that perform a specific function / action of a flowchart and / or block diagram.

[0143] Computer program instructions may be loaded into a computer, other programmable data processing device, or other device, and a computer implementation process may be generated by causing a series of action steps to be executed in the computer, other programmable device, or other device. This ensures that notifications executed in the computer or other programmable device provide the processing necessary to implement specific functions / actions of flowcharts and / or block diagrams.

[0144] Some of the methods described herein are generally designed for use by computers only and may not be feasible or practical to perform purely manually by a human expert. A human expert who wishes to manually perform similar tasks, such as detecting activity in at least one brain region (e.g., a deep brain region, and optionally, a subcortical brain region and / or brain network), or changes in such activity, may be expected to use entirely different methods (e.g., methods that leverage expertise and / or the pattern recognition capabilities of the human brain) that are far more efficient than manually performing the steps of the methods described herein.

[0145] Several embodiments of the present invention are described herein with reference to the accompanying drawings for illustrative purposes only. Details shown here with particular detail in reference to the drawings are for illustrative purposes only and are intended to provide a detailed description of embodiments of the present invention. Similarly, by examining the description together with the drawings, it will be clear to those skilled in the art how embodiments of the present invention can be put into practice. [Brief explanation of the drawing]

[0146] [Figure 1] This is a flowchart of a process for monitoring the condition of a subject receiving NF treatment during and / or after treatment, according to some exemplary embodiments of the present invention. [Figure 2] This is a schematic diagram illustrating the interactions between components of an NF system according to some exemplary embodiments of the present invention. [Figure 3A] This is a block diagram of an NF device according to several exemplary embodiments of the present invention. [Figure 3B] This is a schematic diagram illustrating the interaction between a person receiving NF therapy and a personal device according to some exemplary embodiments of the present invention. [Figure 3C] This flowchart illustrates the activities performed by a subject during NF treatment administered to them, using systems and methods according to some exemplary embodiments of the present invention. [Figure 3D] This is a flowchart illustrating the activities of a subject after completing NF therapy or after at least one treatment, according to some exemplary embodiments of the present invention. [Figure 3E] This is a flowchart illustrating the activities performed by a system for administering NF therapy according to some exemplary embodiments of the present invention. [Figure 4A] This is a schematic diagram of NF treatment according to some exemplary embodiments of the present invention. [Figure 4B] This is a flowchart of a typical NF treatment process according to some exemplary embodiments of the present invention. [Figure 4C] This is a flowchart of the process for performing an NF treatment session according to some exemplary embodiments of the present invention. [Figure 4D] This is a flowchart of the process for performing an NF training cycle according to some exemplary embodiments of the present invention. [Figure 5] This is a flowchart of the process for performing an NF maintenance session according to some exemplary embodiments of the present invention; [Figure 6A] This is a schematic diagram illustrating the generation of EFP signals or electroencephalogram (EEG) signals indicating the activity of at least one brain region and / or at least one brain network according to some exemplary embodiments of the present invention. [Figure 6B] This is a schematic diagram illustrating several exemplary embodiments of the activated NF treatment cycle of the present invention. [Figure 7A] This is a general flowchart of the signal quality determination process according to some exemplary embodiments of the present invention. [Figure 7B] This is a flowchart of a process for determining signal quality according to some exemplary embodiments of the present invention. [Figure 7C] This is a schematic diagram of a user interface for displaying signal quality according to some exemplary embodiments of the present invention. [Figure 7D] This is a general flowchart of an additional process for determining signal quality according to some exemplary embodiments of the present invention. [Figure 7E] This is a flowchart of an additional process for determining signal quality according to some exemplary embodiments of the present invention. [Figure 7F] This is a schematic diagram showing signals recorded on three electrodes according to some exemplary embodiments of the present invention. [Figure 8A] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8B] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8C] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8D] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8E] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8F] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 8G] This diagram shows a schematic representation of an NF system according to some exemplary embodiments of the present invention, specifically an NF supervisor interface displayed to specialists such as NF treatment supervisors. [Figure 9A] This is a flowchart of a process for determining the relationship between the progress of a subject in NF treatment and the subject's condition, according to some exemplary embodiments of the present invention. [Figure 9B] A schematic diagram of an NF supervisor interface according to some exemplary embodiments of the present invention, which shows a graphical representation of the relationship between a score indicating the status of a subject during NF treatment and a treatment progress score. [Figure 9C] A schematic diagram of a visual interface showing the expression of a treatment progress score during NF treatment and the score of a mental state evaluation questionnaire measured during NF treatment according to some exemplary embodiments of the present invention.

Mode for Carrying Out the Invention

[0147] In some embodiments, the present invention relates to the treatment of mental disorders, and more specifically, to the treatment of mental disorders using neurofeedback.

[0148] One aspect of some embodiments relates to performing biofeedback processing, such as administering neurofeedback (NF) treatment to a subject, while monitoring the state of the subject during and / or after NF treatment and modifying the NF treatment in response to the monitoring. In some embodiments, the NF treatment is modified based on the received information regarding the treatment after the treatment, for example, between two consecutive treatment sessions or after the final scheduled treatment session. In some embodiments, at least one new NF treatment session is scheduled based on the state of the subject after NF treatment. Alternatively or additionally, at least one new treatment is initiated or canceled based on the state of the subject after NF treatment.

[0149] According to some embodiments, information about the subject's condition is obtained using one or more questionnaires completed by the subject themselves. Alternatively, one or more questionnaires are completed by a third party who is trained and / or qualified to complete such questionnaires, such as a nurse, caregiver, physician, therapist, social worker, mental health professional, or any other person. In some embodiments, one or more questionnaires include the DSM-5 Clinical Diagnostic Interview Scale for PTSD (CAPS-5) and / or parameters or domains of CAPS-5, the DSM-5 PTSD Checklist (PCL-5), and the Patient Health Questionnaire-9 (PHQ-9). Alternatively or additionally, the Hamilton Depression Rating Scale or its derivatives, the Snays-Hamilton Pleasure Scale (SHAPS) or its derivatives, the Montgomery-Asberg Depression Rating Scale (MADRS) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, and the Clinical Global Impression Scale (CGI). Alternatively or additionally, this may include the Adult Attention-Deficit / Hyperactivity Disorder (ADHD) Investigator's Symptom Rating Scale (AISRS) or its derivative, the Adult ADHD Self-Report Scale (ASRS) or its derivative, the Attention Variable Test (TOVA), or the Patient Health Questionnaire (PHQ).

[0150] In some embodiments, one or more questionnaires are stored in the memory of a device and / or mobile device (e.g., a cellular communication device or tablet) used to administer NF therapy. Alternatively or additionally, one or more questionnaires are stored in the memory of a remote device, such as a remote computer, server device, cloud memory storage and / or processing device. In some embodiments, after a subject completes one or more questionnaires, the completed questionnaires, and / or the subject's responses and / or questionnaire scores, are stored in at least one of the memory of the remote device, the mobile device, and / or the NF device.

[0151] According to some exemplary embodiments, one or more questionnaires are completed using a user interface of a device or mobile device, for example, using software stored in the memory of the device or mobile device. Optionally, one or more questionnaires can be processed and / or analyzed by a control circuit of the device, for example, the control circuit of the device can calculate an overall score for one or more questionnaires, and optionally, the analysis results, for example, the calculated score, can be used to determine the subject's condition, for example, their mental state.

[0152] Alternatively or additionally, the subject's mental state is optionally determined based on information, e.g., signals, received by one or more sensors of the device, e.g., one or more sensors of the device and / or one or more external sensors communicating with the device. In some embodiments, one or more external sensors include wearable sensors and / or sensors coupled to the subject's body. In some embodiments, one or more sensors and / or one or more external sensors include at least one of optical sensors such as a camera, a heart rate sensor, a blood pressure sensor, a skin conductivity sensor, and an electromyography (EMG) sensor. In some embodiments, the subject's mental state is determined based on signals received from at least one electrode configured to record electrical signals (e.g., EEG signals) from the subject's brain.

[0153] One aspect of several embodiments relates to generating a progress score indicating the subject's ability to self-regulate the activity of at least one specific brain region during and / or at the end of an NF therapy session. In some embodiments, a subject state score, e.g., a mental state score, is calculated during NF therapy and presented on a shared interface along with the progress score. In this specification, at least one specific brain region includes at least one specific neural network in some embodiments. In some embodiments, at least one specific brain region is a subcortical brain region.

[0154] In some embodiments, the progress score is based on EEG signals, optionally a subset of EEG signals, recorded from the subject's brain, indicating activity in at least one specific brain region. In some embodiments, the progress score is based on the difference between an EEG signal, or the central trend of said measured EEG signal, that indicates activity in at least one specific brain region during NF, measured while the subject is engaged in active neurofeedback, and a reference index stored in memory. In some embodiments, the reference index is a baseline EEG signal, or a measure of its central trend, measured prior to active NF, indicating a baseline activity level in at least one specific brain region.

[0155] In some embodiments, the progress score is calculated by standardizing the mean EFP difference between the NF cycle and the local baseline median EFP using the local baseline interquantile range (IQR) or other statistical grouping.

[0156] In some embodiments, the system provides a progress score or an indicator thereof to the supervisor of NF treatment and / or the person receiving NF treatment, e.g., the person being trained. In some embodiments, the system presents a correlation, e.g., a graphic correlation, between the calculated progress score and a calculated state score indicating the person's condition, e.g., the person's mental and / or cognitive and / or functional state.

[0157] In some embodiments, the status score is calculated based on scores from a specific questionnaire stored in the system's memory, and / or based on scores assigned to the subject by a professional such as a physician, healthcare professional (HCP), and / or supervisor of NF treatment, and / or based on measurements of at least one physiological parameter performed on the subject. In some embodiments, the score is determined by comparing the patient's questionnaire score, or a derivation thereof, with descriptive statistics of at least one cohort to which the patient may be associated. The patient may be associated with multiple such cohorts, in which case multiple comparisons may be performed and / or presented. Similar presentations could be made for EFP and adjusted performance scores.

[0158] According to some embodiments, the system determines the correlation between the progress score and the mental state score, generates an index with a correlation score, and provides it as an option. In some embodiments, the system provides the correlation score to the supervisor and / or subject.

[0159] One aspect of several embodiments relates to maintaining the effects of NF therapy when a subject with a mental disorder is outside the clinic and, optionally, while engaged in daily activities. In some embodiments, maintenance is achieved by providing the subject with an indicator, e.g., a sensory indicator or trigger (e.g., a sensory trigger), that evokes at least a portion of the NF therapy sessions administered to the subject. Optionally, the sensory indicator comprises at least one trigger selected to evoke at least a portion of the NF therapy sessions administered to the subject.

[0160] In some embodiments, the effect of NF therapy includes the ability of a subject trained by NF therapy to apply, for example, strategies (e.g., mental strategies or cognitive strategies) to control the activity of at least one specific brain region or specific brain network. Optionally, the specific brain network includes a specific brain region.

[0161] According to some embodiments, triggers provided during a maintenance session are selected to evoke at least a portion of an NF session administered to a subject in, for example, a healthcare facility or treatment center. In some embodiments, the triggers are selected and / or configured to evoke at least a portion of an NF session, e.g., sensory markers, feedback signals, instructions, or specific activities (e.g., mental or cognitive strategies) used during the NF session. In some embodiments, the trigger or at least a portion of the triggers are at least partially similar to, for example, at least a portion of an NF therapy session performed during the NF session, e.g., sensory markers, feedback signals, instructions, or specific activities (e.g., mental or cognitive strategies). In some embodiments, the similarity between the trigger and at least a portion of the NF therapy session is due to the similarity of one or more visual and / or acoustic parameters shared between the trigger and at least a portion of the NF therapy session.

[0162] In some embodiments, the similarity between at least one trigger used in a maintenance session and at least a portion of an NF therapy session is at least 1%, for example, at least 10%, at least 20%, at least 40%, at least 50%, at least 70%, at least 80%, or any intermediate percentage, a smaller percentage, or a larger percentage. In some embodiments, the trigger is identical to at least a portion of an NF therapy session, for example, the same sensory indicator, feedback signal, visual interface, auditory interface, and / or instruction used in an NF therapy session.

[0163] In some embodiments, the effect is maintained by presenting the subject with a sensory index that optionally includes scenarios presented during at least one NF therapy session in the clinic, and by optionally instructing the subject to apply mental strategies previously used in at least one NF therapy session. In some embodiments, the subject is instructed to attempt to suppress mental and / or emotional responses to the scenario by applying the mental strategies. Optionally, the presented scenario is a new scenario that was not presented to the subject during the therapy session. Additionally or optionally, the new scenario is a variation of a scenario presented to the subject during the NF therapy session.

[0164] According to some embodiments, maintenance is performed during one or more maintenance sessions. In some embodiments, one or more maintenance sessions are performed according to a predetermined schedule. In some embodiments, the predetermined schedule may be modified based on the subject's mental state. Alternatively or additionally, one or more maintenance sessions may be scheduled or performed if the subject's mental state is determined not to be a target mental state, e.g., a desired mental state, e.g., if the subject's mental state is determined to be lower or higher than a predetermined value. Alternatively or additionally, at least one maintenance session may be scheduled or performed based on the subject's expected mental state.

[0165] According to some embodiments, at least one maintenance session is performed or scheduled based on input received from the subject. Optionally, at least one additional NF treatment session is performed or scheduled based on input received from the subject and input received from at least one of the specialist, NF treatment supervisor, and / or caregiver. Alternatively or additionally, input is received from at least one device or sensor that measures at least one physiological parameter, such as heart rate, EFP signal, blood pressure, skin conductivity, or pupil dilation. In some embodiments, the input includes information or indicators of difficulties the subject is currently experiencing or expects to have (e.g., mental difficulties, cognitive difficulties, and / or behavioral difficulties). In some embodiments, the input includes the results of one or more assessment tests (e.g., one or more questionnaires).

[0166] According to several exemplary embodiments, a system for administering NF therapy assesses the subject's condition during NF therapy before, during, and after active engagement with an NF session. In some embodiments, the assessment is based on input received from the subject or a professional. Alternatively or additionally, the assessment is based on input generated or measured by the system, for example, on changes in EFP signals generated by the system or any other indicator signals indicating activity or changes in activity of at least one specific brain region or brain network. In some embodiments, based on the results of the subject condition assessment, the system modifies or suggests that the NF therapy administered to the subject should be modified. Alternatively, the system suggests modifying the entire therapy administered to the subject, for example, by adding, changing, or discontinuing psychotherapy or pharmacotherapy.

[0167] According to some embodiments, the evaluation of the subject state includes an evaluation of the current subject state with respect to a desired, for example, target or reference state. Alternatively or additionally, the evaluation of the subject state includes an evaluation of the deterioration or improvement of the subject state. In some embodiments, deterioration or improvement, or other indicators regarding the current state of the subject are identified as an input to the system for determining whether to change or modify the treatment for the subject and / or an input to the system for determining whether to perform additional examinations.

[0168] One aspect of some embodiments relates to determining the quality of a signal measured by electrodes attached to the body. In some embodiments, an indicator regarding the quality of the signal is generated. Optionally, the indicator is an indicator detectable by a person, and optionally includes an indicator for improving the abutment and / or contact of the electrode to the body when the determined signal quality is lower than a desired, for example, target quality level. In some embodiments, the signal quality is determined before starting a biofeedback process (for example, a biofeedback treatment or training process) when one or more electrodes are attached to the body of the subject and / or during the biofeedback process (for example, before and / or during a neurofeedback process).

[0169] According to some exemplary embodiments, the quality of the signal is determined by comparing the parameters of the signal recorded within an epoch selected optionally (for example, the peak-to-peak value) with a predetermined absolute value threshold (this threshold is optionally a range of values) or a relative threshold. In some embodiments, the relative threshold is defined with respect to the peak-to-peak value of the selected electrode. In some embodiments, the selected electrode is the electrode that records the signal with the minimum peak-to-peak value. Optionally, if the relative threshold is too close to the minimum value of the absolute threshold, a narrower partial range is defined within the absolute value range or a second absolute threshold with a larger lower limit of the absolute threshold is used.

[0170] Before describing in detail at least one embodiment of the present invention, it should be understood that the applications of the present invention are not necessarily limited to the configuration details and arrangement of elements and / or methods shown in the following description and / or illustrated in the drawings and / or embodiments. Other embodiments of the present invention are possible and can be carried out or implemented by various means.

[0171] Examples of general processes for monitoring patient condition According to some exemplary embodiments, subjects diagnosed with a mental disorder and / or suffering from one or more symptoms of a mental disorder are treated with NF therapy (e.g., NF training). In some embodiments, NF therapy is used to train subjects to control activity, for example, to up-modulate or down-modulate the activity of at least one brain region or at least one brain network. In some embodiments, the brain region and / or brain network is associated with the mental disorder. Alternatively or additionally, the brain region and / or brain network is associated with one or more symptoms. In some embodiments, modifying the activity of a brain region or brain network in a desired direction (e.g., information modulation or down-modulation) suppresses the manifestation of one or more symptoms.

[0172] According to some exemplary embodiments, NF therapy, e.g., NF training, educates the subject to control the activity of at least one brain region and / or at least one brain network, or biomarkers associated with these regions or networks, by instructing the subject to apply a specific strategy (e.g., a task or cognitive task) and providing the subject with feedback on the activity of at least one brain region and / or at least one brain network while applying the strategy. In some embodiments, the feedback provided may also allow the subject to personalize the strategy and select from two or more strategies a particular strategy that is more likely to induce the activity of the brain region or brain network in a desired direction when applied.

[0173] According to some exemplary embodiments, during NF therapy, the subject's condition is determined by receiving subjective or objective input. In some embodiments, the subject's condition is determined during NF therapy, and the NF therapy can be individualized for the subject by modifying the NF therapy as an option, for example, before and / or during the NF therapy session, in accordance with the subject's condition. The overall treatment plan, which may optionally include other treatments besides NF therapy, is modified in accordance with the subject's condition.

[0174] According to some exemplary embodiments, the system providing NF therapy delivers therapy both within and outside the therapy center, for example, at the home of the person receiving therapy, such as a patient or trainee. In some embodiments, the system monitors the person's response to therapy during therapy. Alternatively or additionally, the system monitors the person's state between therapy sessions, for example, their mental and / or cognitive and / or functional state. Alternatively or additionally, the system responds to input from the person, for example, optionally, if the person is unwell or is expected to become unwell in the future due to exposure to a mental state trigger and / or a planned situation.

[0175] According to some exemplary embodiments, the system provides NF therapy (e.g., therapy sessions that provide feedback signals to the patient or trainee) both within and outside the therapy center. Optionally, the system provides NF therapy (e.g., therapy sessions that provide feedback signals to the patient or trainee outside the therapy center and optionally invite the patient to one or more consultations with a specialist within the therapy center).

[0176] According to some exemplary embodiments, the system automatically modifies or suggests modifications to the NF treatment provided to the subject at the treatment center and / or at home, depending on at least one of the subject's monitored state during NF treatment, the subject's state between treatment sessions, and / or inputs received from the subject. In some embodiments, the system suggests modifying, discontinuing, or initiating at least one additional treatment, such as medication, psychotherapy, or behavioral therapy, depending on the subject's monitored state during NF treatment, the subject's state between treatment sessions, and / or inputs received from the subject. Alternatively or additionally, depending on the subject's monitored state during NF treatment, the subject's state between treatment sessions, and / or inputs received from the subject, the system invites the subject to a consultation with a professional, such as a physician or therapist.

[0177] Refer to Figure 1, which illustrates a general process for monitoring the condition of a subject during and / or after NF treatment, according to some exemplary embodiments of the present invention.

[0178] According to some exemplary embodiments, NF therapy is performed in block 102. In some embodiments, NF therapy is performed in one or more (e.g., two or more) therapy sessions. In some embodiments, the NF therapy sessions are performed in a therapy center, e.g., an office or clinic. Alternatively, the NF therapy sessions are performed at home, e.g., using a device that measures EEG signals. In some embodiments, a scenario is presented to the subject during the NF therapy session. In some embodiments, the scenario is individualized for the subject. Alternatively, the scenario is not individualized. In some embodiments, the presented scenario is selected according to the subject's mental disorder and / or according to one or more symptoms.

[0179] According to some exemplary embodiments, a scenario is presented to the subject while providing the subject with feedback signals indicating the activity or biomarker of at least one brain region or brain network, or changes therein. Optionally, the scenario, for example, at least one parameter of the scenario, is modified in response to the indicated activity or changes therein. In some embodiments, the subject is instructed to attempt to modulate the activity or biomarker of at least one brain region or brain network by applying at least one mental strategy, for example, a cognitive task. In some embodiments, by modifying the activity of at least one brain region or brain network, the presented scenario is modified, and implicit (covert) feedback can be provided to the subject regarding the success in modifying the activity of the subject's brain region or brain network in the desired direction. In some embodiments, neurofeedback is implemented as described in International Patent Application Publication No. WO2020121299A1, International Patent Application Publication No. WO2020100144A1, and International Patent Application Publication No. WO2021260697A1, which are incorporated herein by reference in their entirety.

[0180] According to several exemplary embodiments, block 103 receives information about the subject's condition during a treatment session. In some embodiments, the information is received at the start of the treatment session, between neurofeedback blocks in each session, and / or at the end of the treatment session. In some embodiments, the information is received using one or more questionnaires and completed by the subject (e.g., the person being trained in NF training) or the therapist (e.g., a nurse, caregiver, or optionally a qualified professional). Alternatively or additionally, the information is received using one or more sensors configured to sense, for example, at least one physiological parameter such as heart rate, blood pressure, skin conductivity, and / or oxygen saturation. Optionally, the information is received using a camera.

[0181] According to some exemplary embodiments, in block 104, the NF treatment session is optionally modified. In some embodiments, in block 104, at least one parameter of the NF treatment is modified based on the information received in block 103. In some embodiments, the at least one parameter includes at least one of the following: the timing of the NF treatment session, the duration of one or more treatment sessions, the duration of the interval between treatment sessions, and an interface displayed to the subject.

[0182] In some embodiments, the NF session is modified based on information received during at least one NF session and / or based on information received between treatment sessions.

[0183] According to some exemplary embodiments, a maintenance session is administered in block 105. In some embodiments, the maintenance session is administered to the subject without providing feedback signals to the subject. In some embodiments, the maintenance session is administered when the subject is outside the medical center, for example, when the subject is at home and / or at work.

[0184] According to some exemplary embodiments, the subject's state is determined in block 106. In some embodiments, the subject's state, for example, their mental state, is determined in block 106 based on information received in block 104. In some embodiments, the subject's mental state is determined in block 106 during a training session. Alternatively or additionally, for example, when the subject is at home and / or going about their daily life, for example, between therapy sessions, outside of therapy sessions, based on information received from the subject outside the therapy center.

[0185] According to several exemplary embodiments, in block 110, the NF treatment is optionally modified. In some embodiments, in block 110, the NF treatment is optionally modified based on the subject's determined mental state. In some embodiments, if the patient's determined mental state during an NF treatment session indicates a worsening of at least one symptom of the mental state and / or a deterioration of the mental state, the NF treatment session is discontinued or shortened. Alternatively or additionally, a series of NF treatment sessions are modified, for example, by changing the timing of one or more blocks or parts of the treatment session and / or modifying the order of the blocks or parts of the treatment session. Alternatively or additionally, at least one parameter of an NF treatment session is modified, for example, the duration of each NF block, the interval between two consecutive NF blocks, the type of scenario presented to the subject in each NF block, the response rate of the interface, e.g., the visual interface and / or auditory interface, the type of interface, the complexity of the interface, the color of the interface, and / or other natural behavior of the interface, and / or the type of strategy used by the subject. For example, if a patient's assessed mental state during an NF treatment session indicates a worsening of at least one symptom of the mental state and / or a deterioration of the mental state, the subject is instructed to do at least one of the following: apply a different mental strategy, modify an existing mental strategy, and / or select a different mental strategy from the group of mental strategies provided to the subject.

[0186] According to some exemplary embodiments, if the patient's assessed mental state between NF therapy sessions indicates a worsening of at least one symptom of mental state and / or a deterioration of mental state, the subject is instructed to schedule and arrive at an appointment with a therapist, schedule and arrive at an NF therapy session, and / or initiate a maintenance NF session outside the therapy center.

[0187] According to some exemplary embodiments, if the patient's assessed mental state during an NF treatment session indicates a decrease in the severity of at least one symptom of the mental state and / or an improvement in the mental state, the NF treatment session is shortened. Alternatively, the NF treatment session proceeds as scheduled.

[0188] According to some exemplary embodiments, in block 112, the overall treatment administered to the subject is optionally modified based on the determination of the subject's condition during and / or between treatment sessions.

[0189] According to some exemplary embodiments, if the patient's assessed mental state between or during NF treatment sessions indicates a worsening of at least one symptom of the mental state and / or a deterioration of the mental state, the subject is instructed to schedule and / or attend a meeting with the therapist, and / or modify at least one medication regimen, for example, at least one of increasing the dosage of at least one medication.

[0190] According to some exemplary embodiments, if the patient's assessed mental state between or during NF treatment sessions indicates a decrease in the severity of at least one symptom of the mental state and / or an improvement in the mental state, the subject is instructed to reduce the dosage of at least one medication.

[0191] Exemplary NF system According to some exemplary embodiments, the NF system is configured for use in the treatment of subjects diagnosed, for example, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM), and / or subjects suffering from one or more symptoms of a mental disorder. In some embodiments, the NF system is configured to provide a holistic therapeutic environment for the subject, optionally offering treatment, monitoring, data-driven decision support, and guidance for the patient and therapist. In some embodiments, the system is configured to provide personalized telemedicine and monitoring.

[0192] Refer to Figure 2, which illustrates the interactions between components of an NF therapeutic system according to some exemplary embodiments of the present invention.

[0193] According to some exemplary embodiments, an NF system, e.g., system 202, comprises an NF device 204 configured to administer NF therapy to a subject, e.g., patient 206. In some embodiments, the NF device 204 is fixed and installed in a treatment center. Alternatively, the NF device 204 is portable. Optionally, the NF device 204 comprises a pod that is sized and shaped to allow a subject to be positioned inside and receive NF therapy. In some embodiments, the pod is configured to create, for example, an acoustically isolated environment. In some embodiments, the pod includes a door configured to be closed when the subject is inside the pod, e.g., during an NF therapy session.

[0194] According to some exemplary embodiments, the NF device 204 includes at least one user interface for interacting with the patient 206 during an NF therapy session. In some embodiments, the user interface presents patient information relating to NF training and / or presents the patient, for example, at least one scenario or stimulus, during NF training. Alternatively or additionally, or / or, before, during, and / or after NF training, the patient interface provides instructions to the patient 206. In some embodiments, the user interface receives input from the patient 206, for example, the patient 206 can stop NF training and / or ask for help during NF training. According to some exemplary embodiments, the NF device 204 optionally includes at least one expert interface, for example, a supervisor interface, for interacting with an expert 208. In some embodiments, interacting with the expert 208, for example, engaging in dialogue, includes providing information about the patient 206 before, during, and / or after an NF therapy session. Alternatively or additionally, interaction with the expert 208 includes providing information regarding the progress of the NF treatment session and / or the patient 206's performance during the NF treatment session. In some embodiments, the expert interface receives input from the expert 208. In some embodiments, the expert 208 uses the expert interface to modify one or more parameters of the NF treatment or to discontinue the NF treatment.

[0195] According to some exemplary embodiments, the system 202 includes a remote device 210, for example, a server, a remote computer, or a cloud, for example, cloud data storage and / or cloud data processing. In some embodiments, the remote device is optionally located outside the treatment center where the NF device is located, for example, at home. In some embodiments, the remote device 210 communicates with the NF device by wireless and / or wired communication. The remote device 210 also optionally communicates with multiple NF devices located in different treatment centers. In some embodiments, the remote device 210 generates and / or stores one or more databases in the memory of the remote device. In some embodiments, the databases are generated based on information received from the specialist and / or the patient 206. In some embodiments, the remote device stores at least one of formulas, algorithms, and / or lookup tables for processing information received from the patient and / or from the specialist 208.

[0196] According to some exemplary embodiments, the remote device 210 stores one or more NF treatment protocols and / or one or more overall treatment procedures for treating one or more mental disorders, such as psychotherapy and / or drug-related treatments. Optionally, a professional, such as a healthcare worker, inserts protocols into the device's memory, such as a base protocol that can be modified during NF treatment. Alternatively, the remote device stores a base protocol or model of a protocol, optionally modified into at least one valid protocol, based on information received from the user and / or the NF device and / or a professional (e.g., a healthcare worker). Optionally, information is collected when performing at least a portion of the NF treatment. In some embodiments, the remote device 210 uses one or more formulas, algorithms and / or lookup tables to generate new NF treatment protocols, such as an NF treatment protocol personalized for a particular patient or group of patients, based on the information stored in the remote device 210. Alternatively, the remote device 210 may use one or more formulas, algorithms, and / or lookup tables to modify an existing NF treatment protocol, for example, based on information stored in the remote device 210, and personalize the NF treatment protocol for a specific patient or group of patients.

[0197] According to some exemplary embodiments, the remote device 210 uses one or more formulas, algorithms, and / or lookup tables to generate a new overall treatment plan tailored to a specific patient or group of patients, based on information stored in the remote device 210, for example, an NF treatment protocol and at least one additional treatment. Alternatively, the remote device 210 uses one or more formulas, algorithms, and / or lookup tables to modify an existing treatment plan based on information stored in the remote device 210, for example, to personalize an existing treatment plan for a specific patient or group of patients. In some embodiments, the at least one additional treatment includes at least one of psychotherapy, cognitive behavioral therapy (CBT), and pharmacotherapy.

[0198] According to some exemplary embodiments, the remote device 210 uses one or more formulas, algorithms, and / or lookup tables to generate at least one NF treatment protocol and / or at least one treatment plan, e.g., a suggestion or recommendation for an overall treatment plan, based on information stored in the remote device 210. In some embodiments, the remote device 210 can remotely modify and / or replace an existing protocol stored in the NF device, e.g., an NF protocol.

[0199] According to some exemplary embodiments, the remote device 210 communicates with the expert 208. In some embodiments, the expert 208 receives information from and / or provides information to the remote device 210. Optionally, the remote device 210 also communicates with the expert 208 via the expert's personal device, such as the expert's mobile device or personal computer.

[0200] According to some exemplary embodiments, the system 202 further comprises a software program, such as application software or a software suite, installed on the patient's personal device 214. In some embodiments, the personal device 214 comprises a computer, a cellular communication device, a mobile device, a tablet, and / or a wearable device. In some embodiments, the personal device 214 is configured to use a software program installed in the memory of the personal device 214 to receive information from and / or provide information to the patient 206, for example. Optionally, the personal device 214 is configured to detect or measure at least one parameter relating to the patient 206's behavior, such as the patient 206's posture, the patient 206's sleep duration, content created, visualized, engaged with, and / or retrieved by the patient 206 using the personal device, and the patient's operating habits of the device 214. Optionally, or additionally, the personal device 214 measures at least one physiological parameter of the patient 206 using one or more sensors of the device and / or one or more sensors of a device that communicates with the personal device 214.

[0201] In some embodiments, the personal device 214 stores one or more questionnaires (e.g., assessment questionnaires). In some embodiments, the patient completes at least one questionnaire stored in the memory of the personal device 214 according to a scheduled schedule and / or upon request, for example, when requested by a remote device 210 and / or a specialist to complete a questionnaire or to change the questionnaire completion schedule.

[0202] According to some exemplary embodiments, the personal device 214 measures and / or collects data related to the patient's behavior or state when the patient 206 is staying at the treatment center and / or when the patient 206 is outside the treatment center, for example, when the patient 206 is at home, at work, and / or when the patient 206 is engaged in daily life. In some embodiments, the personal device collects information from the patient using an artificial intelligence-driven software application stored in the memory of the personal device 214, which is configured to generate a discussion with the patient 206 on general topics and / or topics related to mental disorder, analyze the patient 206's responses during the discussion, and determine the patient's state based on the analysis results. In some embodiments, the application software analyzes the patient's responses by identifying specific states of the patient, such as words or phrases that indicate the patient's mental state. In some embodiments, the application software also calculates whether the frequency of occurrence of a word or phrase exceeds a predetermined threshold to indicate the severity of the patient's mental state.

[0203] According to some exemplary embodiments, optionally using a software program, measurements taken or collected by the personal device 214 are optionally anonymized and transmitted to the remote device 210. In some embodiments, the remote device 210 uses the information received from the personal device 214 and / or the NF device 204 to determine and / or predict the patient's condition, e.g., mental state. In some embodiments, the remote device 210 uses the information received from the personal device 214 and / or the NF device 204 to determine whether an NF treatment protocol is suitable for the patient's current or predicted condition, whether the overall treatment to be administered to the patient is suitable for the patient's current or predicted condition, propose modifications to an existing NF treatment protocol and / or the overall treatment, propose a new NF treatment protocol and / or the overall treatment, and / or generate a new NF treatment protocol and / or the overall treatment.

[0204] According to some exemplary embodiments, the remote device 210 is configured to provide the professional 208 and / or the patient with indicators regarding the patient 206's current and / or predicted condition, via application software installed on the personal device 214 or on the professional 208's personal device. In some embodiments, the indicators include suggestions on how to modify the patient's NF treatment and / or how to modify the patient 206's overall treatment. Alternatively or additionally, the indicators include predictions of the patient's future condition if the existing NF treatment and / or overall treatment plan is advanced. If the existing NF treatment and / or overall treatment is modified according to the provided suggestions, the indicators include predictions of the patient's future condition.

[0205] Alternatively or additionally, the indicators include predictions of the patient's future condition if existing NF treatments and / or the entire existing treatment are replaced with a new treatment plan based on the proposed solutions.

[0206] According to some exemplary embodiments, a personal device is configured to monitor and determine the subject's state (optionally, mental state) by collecting and / or analyzing data relating to the use of one or more applications and software programs installed in the personal device's memory. Examples include social media applications, mental health applications, and / or applications related to NF treatment. In some embodiments, one or more parameters include timing parameters relating to content inserted or posted and / or input by the subject, and / or the use of applications and / or software programs used by the subject.

[0207] According to some exemplary embodiments, the remote device 210 communicates with one or more external resources 212, such as healthcare providers, health maintenance organizations (HMOs), insurance companies, hospitals, and clinics. In some embodiments, the remote device 210 provides information to one or more external resources regarding the progress of a patient receiving NF therapy, the progress of NF therapy (e.g., the number of sessions performed and / or the number of sessions scheduled), suggesting to the patient discontinue, delay, or start NF therapy, suggesting to the patient additional or different treatment (e.g., discontinuation, delay, or start of drug therapy), or at least one of any suggestions or recommendations generated by the system 202 and / or the remote device with respect to a patient or group of patients.

[0208] Herein, we refer to Figure 3A, which shows an NF device or NF system according to some exemplary embodiments of the present invention.

[0209] According to some exemplary embodiments, the NF system 302, for example the NF device 204 shown in Figure 2, comprises a control unit 304, a patient interface 306, and a supervisor interface 308. In some embodiments, the patient interface 306 and the supervisor interface 308 are functionally connected to a control circuit 310 of the control unit 304. In some embodiments, the control unit 304 comprises a memory 312 that stores at least one algorithm and / or lookup table, for example, an algorithm and / or lookup table used to determine the activity level of at least one brain region among the limbic system brain regions, mesolimbic system brain regions, reward system brain regions, positive valence system brain regions, and negative valence system brain regions. Alternatively or additionally, memory 618 may include at least one EFP, for example, an EFP model of at least one mesolimbic brain region (e.g., the EFP model described in International Patent Application Publication No. 2021260697, which is incorporated herein by whole reference), or an EFP model of at least one limbic brain region (e.g., the amygdala, which is incorporated herein by whole reference). In other embodiments, the EFP model is stored on the EEG or on a computer. In some embodiments, the EFP model enables correlation between EEG signals having a specific frequency band or set of frequency bands, recorded from a specific set of electrodes within a specific time window, and functional magnetic resonance imaging-blood oxygenation level-dependent (fMRI-BOLD) activity of at least one specific brain region or at least one specific network.

[0210] According to some exemplary embodiments, the control unit 304 includes an EEG recording unit 314 functionally connected to the control circuit 310. In some embodiments, the EEG recording unit 314 provides the control circuit 310 with signals from one or more electrodes coupled to the subject's head (e.g., electrodes attached to the skull, implanted in a cortical region of the brain, or implanted in a subcortical region of the brain), thereby processing the received signals and analyzing the processed signals to determine the activity level of at least one brain region, and / or the relationship between the determined activity and at least one reference value or index stored in the memory 312. In some embodiments, as described, for example, in International Patent Application Publication No. 202126697A1 and International Patent Application Publication No. 2012104853A2, whose contents are incorporated as a whole as references, the control circuit 310 uses at least one algorithm, lookup table, and EFP stored in the memory 312 to determine the activity level or the relationship between the activity level and at least one reference value or index.

[0211] According to some exemplary embodiments, the EEG recording unit is functionally coupled to at least one electrode, for example, a plurality of electrodes 316 and 318 positioned on the head 612 of patient 206. In some embodiments, the plurality of electrodes includes any number of positioned electrodes, such as two, three, four, five, six, seven, eight, nine, ten, or more, and is optionally mounted on the head 320 of patient 206. Optionally, the plurality of electrodes are arranged in an array. In some embodiments, the electrodes are positioned at one or more specific locations on the subject's head, for example, at C3, C4, Cz, FCZ, P3, Pz, P4 in the extended 10-20 coordinate system. Alternatively, the electrodes are positioned at any location or combination of locations in the extended 10-20 coordinate system. In some embodiments, the control unit 304 is connectable to at least one speaker or earphone 324 configured to provide audio signals to patient 206. In some embodiments, audio signals are provided to patient 206 using a patient interface 306.

[0212] According to some exemplary embodiments, the control unit includes a communication circuit 326 configured to receive and / or transmit signals, for example, to a remote device 210 located outside the supervisor's clinic, such as a remote computer, remote server, remote cloud, remote storage cloud, or remote processing cloud, which transmits radio signals. In some embodiments, the remote device 210 stores at least one algorithm, lookup table, and / or EFP. In some embodiments, the control unit 304 transmits electrical signals or processed electrical signals to the remote device 210 via the communication circuit 326 and receives signals via the communication circuit 326 indicating the activity level of a brain region and / or the relationship between the activity level of a brain region and a reference value indicating a target activation level of the brain region.

[0213] According to some exemplary embodiments, the control circuit 310 signals the patient interface 306 to display a visual interface on a screen and / or generate an auditory interface, and / or a tactile interface, and / or an olfactory interface, which changes continuously in response to the activation level of a brain region or in response to a change in the activation level relative to a baseline. In some embodiments, the interfaces are updated, for example, every 0.1 seconds, 0.5 seconds, 1 second, 2 seconds, 5 seconds, every 10 seconds, 15 seconds, 20 seconds, 25 seconds, or every intermediate, smaller, or larger value, based on signals received from electrodes 316 and 318. In some embodiments, the patient interface 306 modifies the visual interface presented to the patient with a delay of approximately 5 seconds, approximately 10 seconds, approximately 15 seconds, approximately 20 seconds, approximately 25 seconds, or any intermediate, smaller, or larger value relative to the timing of electrical signals received from electrodes 316 and 318. In some embodiments, the patient interface includes a display and / or a speaker.

[0214] According to some exemplary embodiments, the sensory indicators for the patient, e.g., the patient interface, are provided in two dimensions (2D) or three dimensions (3D), with or without an auditory interface. Alternatively, the interface is an auditory interface only. In some embodiments, the patient interface is provided using virtual reality, augmented reality, and may or may not include at least one of auditory, olfactory, and tactile feedback.

[0215] According to some exemplary embodiments, the control circuit 310 signals the supervisor interface 308 to provide the treatment supervisor with visual and / or auditory indicators. In some embodiments, the visual and / or auditory indicators indicate the patient's progress during treatment, the activity level of a brain region (e.g., the amygdala) or its biomarkers, changes in the activity level of a brain region, the difference between a baseline and the activity level of a brain region, the stage of the NF session, the operation of the system, and at least one of the indicators or cues provided to the patient. Optionally, the supervisor interface 308 is the supervisor's personal device connected to the control unit 304 and / or remote device 210 via a communication circuit 326. In some embodiments, the control unit 304 transmits at least one of the data collected from the patient, the data transmitted to or displayed to the supervisor, to the remote device, for example, to generate a database. In some embodiments, the dataset includes information collected from multiple systems and / or multiple patients.

[0216] According to some exemplary embodiments, the system 302 comprises one or more sensors 325 coupled to the patient's body (e.g., head 320) during NF treatment. In some embodiments, one or more sensors 325 are configured to detect at least one physiological parameter of the patient 206, such as heart rate, blood pressure, and / or skin conductivity, from the patient in the treatment center before, during, and / or after the treatment session. In some embodiments, the system comprises at least one camera 327, which is configured to capture a visual appearance of the patient 206 in the treatment center before, during, and / or after the treatment session.

[0217] According to some exemplary embodiments, the control circuit 310 and / or remote device 210 determine the patient's condition when the patient is in the treatment center before, during, and / or after a treatment session, based on signals received from one or more sensors 325, signals received from a camera 327, and / or reference EEG signals measured using electrodes 316 and 318.

[0218] According to some exemplary embodiments, signals received from one or more sensors 316, 318, camera 327, and / or electrodes 316, 318 are used to determine whether patient 206 is in a suitable condition to initiate active NF or whether the patient's condition is unsuitable for initiating active NF. Alternatively or additionally, the received signals are used to determine whether it is appropriate to continue active NF while the patient is receiving it, or whether the patient's condition indicates that active NF should be discontinued or shortened.

[0219] Here, we refer to Figure 3B, which shows how a patient interacts with a personal device while receiving treatment for a mental disorder, for example, according to some exemplary embodiments of the present invention.

[0220] According to some exemplary embodiments, for example, at least one application software stored in the memory of a personal device 214 is used to collect information from a patient using one or more sensors coupled to the patient's body 206. In some embodiments, one or more sensors are sensors of at least one wearable device, such as a smartwatch 340, a band, a bracelet, and / or a headband 342. In some embodiments, the wearable device is coupled to, for example, the patient's body, e.g., attached, and communicates with, e.g., the personal device 214 wirelessly. In some embodiments, one or more sensors of the wearable device include at least one gyroscope and / or accelerometer and are configured to sense the position, posture, and / or orientation of the patient's body. Alternatively or additionally, the wearable device is configured to sense at least one physiological parameter, such as heart rate, blood pressure, and / or skin conductivity.

[0221] According to some exemplary embodiments, the wearable device is configured to receive signals from one or more sensors and / or transmit signals to a personal device 214 while the patient 206 is in a treatment center, optionally receiving NF treatment, and / or while the patient is outside the treatment center, for example, at home, and / or during daily activities. In some embodiments, one or more sensors of the personal device 214 are used to sense at least one physiological parameter of the patient 206's body and / or position, posture, and / or orientation. In some embodiments, the personal device 214 transmits signals or indicators received from the sensors of the wearable device and / or personal device to a remote device 210. In some embodiments, the remote device 210 and / or personal device 214 are configured to determine the patient's condition based on the received signals or indicators. In some embodiments, the remote device 210 and / or personal device 214 are configured to determine, based on the received signals, the degree of patient 206's involvement in treatment with NF therapy, for example, by optionally identifying the patient's daily habits, such as sleep, exercise, outdoor activities, time spent outdoors, and social interaction habits.

[0222] According to some exemplary embodiments, at least one of the control circuit 310, memory 312, communication circuit 326, EEG recording unit 314, supervisor interface 308, and / or patient interface 306 is a component of system 302 or system 202 shown in Figure 2.

[0223] Example flow of activities for the target group According to several exemplary embodiments, the system for administering NF therapy is used as a treatment for subjects diagnosed with stress disorders, e.g., human subjects. Alternatively or additionally, the system is used to treat subjects with behavioral, cognitive, and / or social difficulties. In some embodiments, the system is used to manage NF therapy and, as an option, additional treatments administered to a subject. The system is also used to monitor the subject's condition during NF therapy sessions and / or in their daily life. Alternatively or additionally, the system is used to provide suggestions and / or recommendations to subjects when they are experiencing or anticipate experiencing mental, social, and / or behavioral difficulties.

[0224] Here, we refer to Figure 3C, which shows the flow of activities performed by a subject using a system according to some exemplary embodiments of the present invention.

[0225] According to some exemplary embodiments, in block 350, the subject is optionally diagnosed with a mental disorder. In some embodiments, the subject is diagnosed with a mental disorder according to the DSM. In some embodiments, the subject is diagnosed, for example, by a physician or psychiatrist. In some embodiments, the subject's diagnosis includes characterizing the type, stage, and / or severity of the mental disorder.

[0226] In some exemplary embodiments, NF therapy is prescribed to the subject as an option in block 352. In some embodiments, NF therapy is prescribed to the subject based on the diagnosis made in block 350. In some embodiments, the prescribed NF therapy is adjusted according to the type, stage, and / or severity of the subject's mental disorder. In some embodiments, prescribing NF therapy to a subject includes suggesting or advising the subject to undergo NF therapy, which may be done optionally without a prior diagnosis of mental disorder in the subject. In some embodiments, a social worker and / or therapist recommends that the subject undergo NF therapy, for example, as treatment for the subject's mental, social, behavioral, and / or cognitive difficulties.

[0227] According to some exemplary embodiments, in block 354, the subject receives an NF therapy session. In some embodiments, the subject performs the NF therapy session within and / or outside the therapy center, for example, at home. In some embodiments, the NF therapy comprises one or more (e.g., two, four, six, ten, twelve, fourteen, twenty, or any other intermediate number of fewer or more) therapy sessions. In some embodiments, the interval between therapy sessions is at least one hour, for example, at least six hours, at least twelve hours, at least twenty-four hours, at least forty-eight hours, or an intermediate shorter or longer time interval between two consecutive NF therapy sessions. In some embodiments, during an NF therapy session, the subject optionally receives online feedback signals indicating the activity level of at least one specific brain region or at least one specific brain network.

[0228] According to some exemplary embodiments, the subject undergoes, optionally, one or more NF therapy maintenance sessions in block 356. In some embodiments, the subject performs an NF therapy maintenance session (also referred to herein as a maintenance session) between NF therapy sessions. In some embodiments, during a maintenance session, the subject is instructed to modulate the activity of at least one brain region or brain network as instructed and trained during an NF therapy session. In some embodiments, during a maintenance session, the subject does not receive feedback signals regarding the activity of at least one specific brain region or brain network. Alternatively, the subject receives feedback during a maintenance session based on a measurement of at least one physiological parameter (e.g., heart rate, blood pressure, or any physiological parameter directly or indirectly affected by the activation level of at least one brain region and / or brain network).

[0229] According to some exemplary embodiments, the subject engages in daily activities, for example, between two NF treatment sessions and / or upon completion of an NF treatment session.

[0230] According to some exemplary embodiments, in block 358, the subject is optionally unwell. In some embodiments, the subject experiences an increase or exacerbation of one or more symptoms associated with a mental disorder, and / or experiences distress.

[0231] Alternatively, in block 360, the subject anticipates difficulties as an option. In some embodiments, the subject anticipates future difficulties due to events that are expected to occur in the future. In some embodiments, the anticipated difficulties include behavioral, social, mental, and / or cognitive difficulties.

[0232] According to several exemplary embodiments, the subject may optionally provide a report (block 362). In some embodiments, the subject provides a report on their current mood and / or current condition. Alternatively or additionally, the subject provides a report on anticipated difficulties. In some embodiments, the subject reports to the system via a user interface, for example, using a remote device 210 shown in Figure 3A, or a personal device communicating with the remote device 210, for example, a personal device 214 shown in Figure 3B. In some embodiments, the subject optionally provides a report using application software that functions as the user interface of the system. In some embodiments, providing a report optionally includes, using a user interface, at least one of completing one or more questionnaires, measuring at least one physiological parameter, and performing at least one assessment.

[0233] According to some exemplary embodiments, in block 364, the subject optionally receives instructions. In some embodiments, the instructions include recommendations or suggestions. In some embodiments, the subject receives instructions from the system via a user interface (e.g., via the user interface of a remote device 210 or personal device 214).

[0234] According to some exemplary embodiments, the instructions include instructions in block 366 to perform one or more maintenance sessions. In some embodiments, the instructions include instructions to modify one or more parameters of the maintenance session depending on the current mood or current state, or the expected difficulty. In some embodiments, one or more parameters include, for example, the duration of the maintenance session or part thereof, the timing of the maintenance session, for example, when to perform the maintenance session, and / or the content of the maintenance session.

[0235] According to some exemplary embodiments, in block 368, the instructions include prompting the subject to arrive at an NF therapy session. In some embodiments, the NF therapy session is rescheduled according to the subject's current mood, current condition, or anticipated difficulties.

[0236] According to some exemplary embodiments, the instructions include instructions to initiate a different treatment, such as pharmacotherapy, in block 370. In some embodiments, the instructions include instructions to administer a pre-prescribed medication to the subject as an option. Alternatively or additionally, the instructions include instructions to perform at least one of the following: psychotherapy, behavioral therapy, mental exercises, cognitive exercises, and motor exercises. Alternatively or additionally, the instructions include instructions to arrive at an appointment with a professional or therapist. Optionally, the system schedules an appointment with a professional or therapist, and the instructions include instructions to arrive at the scheduled appointment.

[0237] According to some exemplary embodiments, the subject optionally reports their subject status in block 372, for example, periodically. In some embodiments, the subject reports according to a reporting schedule determined by the system and / or optionally by a specialist or therapist monitoring the NF treatment. In some embodiments, the subject provides reports on their subject status during the interval between NF treatment sessions. In some embodiments, if the subject's report indicates a subject status or change that is not a desired state or change, the subject receives instructions, for example, as described in block 364.

[0238] In some exemplary embodiments, in block 372, the subject provides a report using the user interface of a remote device (e.g., remote device 210 shown in Figure 3A) or via a personal device (e.g., personal device 214 communicating with remote device 210, shown in Figure 3B), as described in block 362. In some embodiments, the subject provides the report using application software that optionally functions as the system's user interface. In some embodiments, the provision of the report comprises at least one of completing one or more questionnaires, measuring at least one physiological parameter, and performing at least one assessment, and is optionally done using the user interface.

[0239] Here, we refer to Figure 3D, which shows the flow of activities of a subject after the completion of NF treatment using a system according to some exemplary embodiments of the present invention.

[0240] According to some exemplary embodiments, after NF treatment is completed in block 374, the subject optionally provides the system with a report on their condition. In some embodiments, the subject submits the report as part of a planned routine, for example, at least once a day, at least once a week, at least once every two weeks, at least once a month, or at shorter, intermediate, or longer time intervals. In some embodiments, the subject provides the report as described in block 372.

[0241] According to some exemplary embodiments, after NF therapy is completed in block 374, the subject optionally undergoes one or more maintenance sessions in block 378. In some embodiments, the maintenance sessions are performed as described in block 356. In some embodiments, the maintenance sessions are optionally performed according to a predetermined routine or plan, e.g., a post-treatment plan. In some embodiments, the post-treatment plan is determined by the system and / or a specialist or therapist. In some embodiments, the post-treatment plan includes actions that the subject should take after NF therapy is completed, for example, when the subject is at home and / or going about their daily life.

[0242] According to some exemplary embodiments, if the subject is optionally feeling unwell (block 382) or anticipates difficulties (block 380), the subject provides a report in block 384. In some embodiments, the subject provides a report in block 384, for example, as described in block 362.

[0243] According to some exemplary embodiments, instructions are given to the subject in block 386 based on a report provided by the subject in block 384. In some embodiments, instructions are given in block 392 to perform at least one maintenance session, and / or in block 390 to attend a booster NF treatment session, and / or in block 388 to take medication, perform another treatment, and / or perform exercise (as also described in block 370, for example). Alternatively and / or additionally, instructions are given in block 394 to attend a consultation with a specialist or therapist. Optionally, the meeting is scheduled by or using the system.

[0244] Example Flow of System Activities According to some exemplary embodiments, the system is configured to perform at least one of the following actions within and / or outside of a treatment center: administer NF therapy to a subject; monitor the subject's condition during NF therapy; monitor the subject's progress during NF therapy; modify NF therapy as necessary; administer on-demand therapy to a subject; respond to input from the subject; and / or make suggestions and / or recommendations to the subject based on input received from the subject and / or other input collected by the system.

[0245] Refer to Figure 3E, which shows a sequence of operations performed by the system according to some exemplary embodiments of the present invention.

[0246] In some exemplary embodiments, the system optionally checks the subject's suitability for NF treatment in block 353. In some embodiments, the system checks the subject's suitability for NF treatment by reading signals such as EEG signals from the subject's brain while the subject performs at least a portion of an NF training session (e.g., NF training).

[0247] According to some exemplary embodiments, the system administers NF therapy to the subject in block 355. In some embodiments, the system administers one or more NF training sessions to the subject.

[0248] According to some exemplary embodiments, the system monitors the subject's performance during an NF therapy session in block 357. In some embodiments, the system monitors the subject's ability to modulate the activity of at least one specific brain region or at least one specific brain network in a desired direction, optionally based on EEG signals measured from the subject's brain.

[0249] According to some exemplary embodiments, the system monitors the subject's condition during NF therapy in block 359. In some embodiments, the system monitors the subject's condition, e.g., mental, cognitive, and / or physiological state, during at least one NF training session or during each NF training session. In some embodiments, the system monitors the subject's condition based on inputs received from, for example, questionnaires completed by the subject, measurements of electrical signals from the subject's body, e.g., EEG signals, and / or measurements of at least one physiological parameter. Alternatively or additionally, the system monitors the subject's condition based on information received by at least one optical sensor, such as a camera. Alternatively or additionally, the system monitors the subject's condition based on information received from professionals, therapists, caregivers, and / or the subject's family.

[0250] According to some exemplary embodiments, the system optionally modifies at least one parameter of the NF treatment, e.g., NF treatment, in block 361. In some embodiments, the system modifies the NF treatment, for example, by modifying the duration of one or more treatment sessions, the number of treatment sessions, the content of one or more treatment sessions, the duration between treatment sessions, the duration and / or content of maintenance sessions, and / or the order of one or more blocks of treatment sessions and / or the duration of at least one block, e.g., at least one of the block order and / or duration shown in Figures 4C and 4D, and / or by shortening or discontinuing at least one treatment session or the entire NF treatment, for example.

[0251] According to some exemplary embodiments, the system administers one or more maintenance sessions (block 363). In some embodiments, the system administers one or more maintenance sessions to a subject when the subject is outside the treatment center, for example, when the subject is at home. In some embodiments, the maintenance session includes one or more elements, for example, features shared with the NF treatment administered to the subject (e.g., an audio interface and / or a visual interface presented to the subject). In some embodiments, the system provides the subject with indicators before the start of a maintenance session and / or before the end of a maintenance session.

[0252] According to some exemplary embodiments, when the system receives information that a subject is unable to attend a scheduled maintenance session, it reschedules the maintenance session and provides an indicator to the subject and / or the supervisor of NF treatment, such as a specialist or therapist.

[0253] According to some exemplary embodiments, the system optionally receives indicators regarding the subject's condition in block 365. In some embodiments, the indicators are based on information received directly from the subject, for example, as described in blocks 362, 372, and 384 of Figures 3C and 3D. Alternatively or additionally, the system receives indicators regarding the subject's condition, for example, as described in block 376. In some embodiments, the system receives indicators when the subject is outside the treatment center, for example, after being discharged home or when the subject is at home or at work.

[0254] According to some exemplary embodiments, the system optionally sends instructions to the subject in block 367. In some embodiments, the system sends instructions to the subject based on indicators received in block 365.

[0255] In some exemplary embodiments, block 369 includes instructions to perform at least one maintenance session. In some embodiments, block 371 optionally includes instructions to visit a clinic specialist or therapist. In some embodiments, block 373 includes taking medication and / or performing at least one additional treatment. In some embodiments, block 377 includes instructions to modify the maintenance session and / or additional treatment. In some embodiments, the instructions include instructions to perform at least one additional NF session, such as an NF booster session.

[0256] Example of NF treatment According to some exemplary embodiments, NF therapy administered to a patient is designed to train the patient to self-regulate, for example, the activity of a specific brain region, or a brain network including said brain region, or a brain network associated with said brain region. In some embodiments, self-regulation of activity, such as up-modulating or down-modulating activity, can alleviate or prevent, for example, at least one symptom of a mental disorder.

[0257] According to some exemplary embodiments, NF therapy includes one or more NF sessions instructing a patient on at least one strategy, such as a cognitive task, while receiving feedback on the activity of at least one brain region and / or at least one brain network during the application of the strategy. In some embodiments, the received feedback can help the patient find the best strategy to modulate the activity of the brain region and / or brain network in a desired direction. In some embodiments, the feedback on the activity of the brain region or brain network is received by measuring EEG signals only, and optionally can be done using an Electrical Fingerprint (EFP) of the brain region or brain network generated by correlating the blood oxygenation level-dependent (BOLD) activity of the brain region or brain network with a specific set of EEG signals.

[0258] Herein, we refer to Figure 4A, which shows a general overview of NF therapy according to some exemplary embodiments of the present invention.

[0259] According to some exemplary embodiments, NF therapy 402 includes an NF therapy period 404 followed by an NF therapy maintenance period 406. In some embodiments, the NF therapy period 404 includes two or more treatment sessions, e.g., treatment sessions 408, 410, and 412, over a period of time of, for example, at least one week, at least two weeks, at least four weeks, at least one month, at least two months, at least four months, or any intermediate, shorter, or longer period. In some embodiments, the above treatment sessions are administered at a frequency of one treatment session per week, two treatment sessions per week, three treatment sessions per week, four treatment sessions per week, one treatment session per day, or any intermediate, fewer, or more treatment sessions per week. In some embodiments, the length of the NF therapy period and / or the number of treatment sessions during this period are individualized for a particular subject, for example, based on the subject's condition before the initiation of NF therapy, and / or based on the subject's condition during the NF therapy period 404, and / or based on the subject's condition during one or more treatment sessions 408, and / or based on the subject's condition between treatment sessions.

[0260] According to some exemplary embodiments, during the NF therapy period 412, a subject's personal device, for example, the personal device 214 shown in Figures 2 and 3B, is used to receive input, such as feedback, from the subject during the treatment session (e.g., in 414) and / or between treatment sessions (e.g., in 416). In some embodiments, the personal device 214 also receives information from the subject using a software program installed in the memory of the personal device 214. In some embodiments, the personal device 214 receives information explicitly and / or implicitly, such as information about the subject's condition. In some embodiments, the personal device 214 explicitly receives information from the subject, for example, by having the subject complete one or more questionnaires stored in the memory of the device 214. In some embodiments, the personal device 214 implicitly receives information from the subject by using signals from one or more sensors of the personal device or one or more sensors of a device coupled to the personal device, using signals from the camera of the personal device or a camera directly or indirectly coupled to the personal device, monitoring the subject's habits of using the personal device 214, identifying words and / or phrases in conversations via the device 214, monitoring written discussions, conversations, and / or voice calls conducted by the personal device 214, and / or using one or more sensors of the personal device 214.

[0261] According to some exemplary embodiments, the personal device 214 is used to receive information from the subject when the subject is at the treatment center during an NF treatment session, and / or when the subject is outside the treatment center, for example, at home, and / or going about their daily life.

[0262] According to some exemplary embodiments, after completing NF therapy period 404, the subject optionally enters NF therapy maintenance period 406. In some embodiments, during period 406, the subject is at home and / or carrying out daily activities. In some embodiments, during period 406, at least one software application stored in the memory of the personal device 214 is used to expose the subject to scenarios similar to or identical to those conducted during sessions 408, 410, and 412, for example, and to instruct the subject to apply the strategies used by the subject during sessions 408, 410, and 412, thereby maintaining the effects of NF therapy, such as NF training performed in 404, in one or more maintenance sessions, such as sessions 418 and 420.

[0263] According to some exemplary embodiments, maintenance sessions 418, 420 are enforced according to a scheduled schedule, for example, twice a day, once a day, twice a week, three times a week, or fewer or more times per week. Alternatively, the sessions to be maintained are enforced on request or in accordance with information or signals transmitted from a remote device, for example, the remote device 210 shown in Figures 2, 3A, and 3B, to the personal device 214.

[0264] According to some exemplary embodiments, during the maintenance period 406, the personal device 214 is used to receive information from the subject, for example, as described with respect to the treatment period 404, in order to determine the subject's condition. In some embodiments, the personal device 214 receives information from the subject before, during, and / or after the maintenance session.

[0265] According to some exemplary embodiments, during period 406, the subject's condition is determined based on information received by the personal device. Alternatively or additionally, the NF therapy effect size during period 406 is determined based on information received by the personal device. In some embodiments, if the determined NF therapy effect size is lower and / or higher than a predetermined level, the subject is invited to one or more additional NF therapy sessions, e.g., booster NF sessions 422 and 424. In some embodiments, during booster sessions 422 and 424, the subject receives an NF therapy session either within the treatment center or outside the treatment center, e.g., using a portable NF device.

[0266] According to some exemplary embodiments, the personal device 214 is used to monitor the subject's condition after an NF therapy period 404 and to instruct the subject to, optionally based on the subject's condition and / or determined NF effect size, to participate in one or more NF booster sessions, to schedule an appointment with a therapist such as a psychologist or psychiatrist, to discontinue at least one medication, or to initiate at least one medication.

[0267] Refer to Figure 4B, which shows a general NF treatment process according to some exemplary embodiments of the present invention.

[0268] In some exemplary embodiments, in block 440, the subject is diagnosed. In some embodiments, the subject is diagnosed with a mental disorder according to a standard classification of mental disorders used by mental health professionals, such as the Diagnostic and Statistical Manual of Mental Disorders (DSM).

[0269] According to some exemplary embodiments, in block 442, at least one first treatment is optionally initiated. In some embodiments, at least one first treatment includes at least one of pharmacotherapy, psychotherapy, cognitive behavioral therapy (CBT) or dialectical behavior therapy (DBT), and electroconvulsive therapy (ECT). In some embodiments, the first treatment is selected and initiated depending on the diagnosed mental disorder.

[0270] In some exemplary embodiments, in block 444, the expert determines whether to initiate NF therapy in the subject. In some embodiments, the expert determines whether to initiate NF therapy based on the diagnosis made in block 440 and / or based on the diagnosed mental disorder. Optionally, the expert determines whether to initiate NF therapy as a complementary treatment to at least one first treatment, for example, if the desired results are not obtained with the first treatment alone. Optionally, the expert determines whether to initiate NF therapy in place of at least one first treatment.

[0271] According to some exemplary embodiments, during NF treatment 446, the subject participates in one or more treatment sessions in block 448, for example, two, three, four, five, ten, fifteen, twenty, or any intermediate number, fewer, or more treatment sessions. In some embodiments, the NF treatment sessions are conducted at a treatment center, as shown, for example, in Figures 1 and 4A.

[0272] According to some exemplary embodiments, in block 450, the subject's state, e.g., mental state, behavioral state, and / or cognitive state, is monitored during NF therapy 446 and / or during NF therapy session 448. In some embodiments, the subject's state is monitored using information and / or feedback received from the subject. Alternatively or additionally, the subject's state is monitored based on signals and / or measurements recorded or received from the subject. In some embodiments, the subject's state is monitored as described, for example, in Figures 1, 3A, and 3B.

[0273] According to some exemplary embodiments, at least one second treatment is optionally initiated in block 462. Optionally, at least one second treatment is initiated based on the results of monitoring performed in block 450. In some embodiments, at least one second treatment includes at least one of pharmacotherapy, psychotherapy, CBT therapy, and electroconvulsive therapy (ECT). In some embodiments, a first treatment is selected and initiated depending on the diagnosed mental disorder.

[0274] According to some exemplary embodiments, in block 464, at least one first treatment is optionally modified. In some embodiments, at least one first treatment is modified based on the results of monitoring performed in block 450. In some embodiments, at least one parameter relating to the first treatment, such as the drug administration schedule, drug dosage, drug type, and / or the number of first treatments, is modified.

[0275] According to some exemplary embodiments, in block 452, one or more parameters of the NF treatment session are optionally modified based on the results of monitoring. In some embodiments, one or more parameters of the NF treatment session are modified based on the state of the monitored subject. In some embodiments, one or more NF treatment parameters include at least one of the following: the length of at least one treatment session, the difficulty level at the start of at least one treatment session, the length of the interval between two treatment sessions, the number of treatment sessions, the scheduling details of at least one treatment session, the type of interface presented to the subject in the treatment session, the number, timing, and / or sequence of blocks within the treatment session, the number and / or location of electrodes used in at least one treatment session, the number and / or type of electrical fingerprints (EFPs), and / or the number and / or type of NF treatment protocols.

[0276] According to some exemplary embodiments, modifying an NF treatment session includes discontinuing at least one treatment session or discontinuing all treatment.

[0277] According to some exemplary embodiments, the NF treatment session ends in block 454. In some embodiments, the NF therapy period, for example, the therapy period 404 shown in Figure 4A, ends in block 454. The length of the NF therapy period 404 is determined in block 444. Optionally, the length of the NF therapy period is modified, for example, during the NF treatment 446, based on the subject's condition monitored, for example, in block 450.

[0278] In some exemplary embodiments, in block 456, the subject's condition is monitored after the completion of NF treatment. In some embodiments, the subject's condition is monitored as described in block 450. In some embodiments, the subject's condition is monitored according to a specific monitoring schedule. Alternatively, monitoring of the subject's condition is performed on demand, such as when a signal is received from a remote device, for example, the remote device 210 shown in Figures 2, 3A, and 3B. In some embodiments, in block 456, the subject's condition is monitored using a personal device, for example, personal device 214. In some embodiments, the subject's condition is monitored in block 456 when the subject is outside the treatment center, for example, when the subject is at home or going about their daily life.

[0279] According to some exemplary embodiments, in block 458, the patient's condition is determined to be an undesirable condition. In some embodiments, an undesirable condition is a condition that is not a target condition, e.g., a target condition according to a treatment plan, and / or a target condition according to known standards in the field of treatment and / or diagnosis of mental disorders. In some embodiments, an undesirable condition is an unusual condition according to standards known in the field of treatment and / or diagnosis of mental disorders.

[0280] According to some exemplary embodiments, if the subject state is not a target state, or if the subject state indicates a deterioration of the subject state relative to a baseline state, at least one NF maintenance session is optionally administered to the subject (block 460). In some embodiments, at least one NF maintenance session includes a session in which the subject is presented with an interface (e.g., a visual interface and / or an auditory interface) and instructed to apply a mental strategy. In some embodiments, the mental strategy is a strategy that has been shown to modulate the activity of at least one brain region or at least one brain network in the subject or in other subjects during an active neurofeedback session. Alternatively or additionally, an interface presented to the subject during NF maintenance is an interface presented to the subject during an active neurofeedback session.

[0281] According to some exemplary embodiments, if the subject's condition is not the target condition, at least one first therapy in block 464 is optionally modified, for example, as described above.

[0282] According to some exemplary embodiments, if the subject's condition is not the target condition, for example, as described above, at least one second therapy is optionally initiated in block 462, or at least one second therapy is optionally modified.

[0283] Example NF treatment session According to some exemplary embodiments, NF therapy includes at least one, e.g., two or more, NF therapy sessions occurring at different times. In some embodiments, each NF therapy session is conducted at a therapy center. Optionally, at least one, some or all, of the NF therapy sessions are conducted at home or outside the therapy center. In some embodiments, during an NF therapy session, the subject is given feedback regarding the activity of at least one brain region or at least one brain network based on EEG signals measured from the subject's head. In some embodiments, the subject receives feedback for less than one minute, e.g., less than 30 seconds, less than 15 seconds, less than 10 seconds, less than 5 seconds, or an intermediate, shorter, or longer period from the measurement of the EEG signals.

[0284] Here, we refer to Figure 4C illustrating the process for performing an NF treatment session according to some exemplary embodiments of the present invention.

[0285] According to some exemplary embodiments, the treatment center may optionally be visited by individuals such as patients who have been previously diagnosed with a mental disorder. Alternatively, the individuals may optionally stay outside the treatment center, for example, at home.

[0286] According to some exemplary embodiments, in block 472, the subject's condition is optionally evaluated. In some embodiments, the subject's condition, for example, their mental and / or cognitive state, is evaluated while the subject is at the treatment center. Alternatively, the subject's condition is evaluated before arriving at the treatment center, for example, while the subject is at home.

[0287] According to some exemplary embodiments, in block 472, the subject's condition is optionally evaluated, for example, by receiving information from the subject. In some embodiments, the subject's condition is evaluated, for example, by completing one or more questionnaires using an NF device at a treatment center and / or using the subject's personal device. Alternatively or additionally, the subject's condition is evaluated using one or more sensors, for example, sensors on the NF device, sensors on the subject's personal device, and / or sensors on a device that communicates with the NF device and / or the subject's personal device. In some embodiments, in block 472, the subject's condition is evaluated as previously described in Figures 1, 2, 3A, 3B, and 4B.

[0288] According to some exemplary embodiments, the subject's condition is optionally assessed in block 472, for example, to establish a baseline or reference state. Alternatively or additionally, the subject's condition is optionally assessed in block 472 to determine whether the subject is able to participate in NF therapy sessions, for example, from a mental and / or cognitive standpoint.

[0289] According to some exemplary embodiments, in block 472, the subject's condition is optionally automatically evaluated, for example, by automatically giving instructions to the subject. Alternatively, the subject's condition is optionally evaluated based on signals received from a specialist, such as a therapist, who is in charge of and / or monitoring the NF treatment session.

[0290] According to some exemplary embodiments, in block 474, one or more electrodes are coupled to the subject's body. In some embodiments, one or more electrodes are coupled to the subject's head and configured to record signals from the subject's brain. In some embodiments, one or more electrodes, for example electrodes 316, 318 shown in Figure 3A, are coupled, for example, to the subject's scalp. Alternatively, one or more electrodes are positioned at specific locations on the subject's head, optionally according to an EEG coordinate system (e.g., a 10-20 coordinate system or a variation thereof). In some embodiments, at least one electrode, for example a reference electrode, is coupled to the subject's head, for example, to the subject's ear or earlobe. Optionally, the electrodes are coated with a conductive material, such as a gel. Optionally, the electrodes are coupled to the subject's head using an alignment cap, optionally having an opening, based on an EEG coordinate system.

[0291] According to some exemplary embodiments, signal quality is determined in block 476. In some embodiments, determining signal quality includes determining that one or more electrodes are in contact with, for example, the subject's scalp. Alternatively or additionally, determining signal quality includes determining that the contact of one or more electrodes with the subject's body surface, for example, the subject's scalp, is sufficient to record a signal usable during an NF session, optionally a signal usable for EEG measurement. Alternatively or additionally, determining signal quality includes determining that the signal generated by one or more electrodes is suitable for EEG measurement. Optionally, determining signal quality includes determining that the wiring between electrodes to the NF device and / or amplifier is connected and operating in a way that allows for the recording of electrical signals by one or more electrodes.

[0292] According to some exemplary embodiments, in block 478, a global baseline is optionally measured. In some embodiments, the global baseline is measured while an unrelated interface and / or static interface, such as an auditory interface and / or a visual interface, is provided to the subject. In some embodiments, the interface is displayed to the subject. In some embodiments, the interface is one that is not used in actual NF training and / or is unrelated and / or is not in the context of the subject's mental disorder and / or is a static interface that does not change during global baseline measurement. In some embodiments, the unrelated interface is presented to the subject for a period of time ranging from, for example, 10 seconds to 5 minutes, e.g., 1 minute to 3 minutes, 2 minutes to 3 minutes, or other intermediate periods, shorter periods, or longer periods.

[0293] As an option or alternative, global baseline measurements are used to determine the status of subjects.

[0294] According to some exemplary embodiments, during the global baseline measurement in block 478, no feedback is provided to the subject regarding the activity level or biomarkers of at least one brain region or at least one brain network. In some embodiments, the measured global baseline is a baseline signal (e.g., an electrical fingerprint (EFP) signal) indicating the baseline activity level when the subject is at rest and not engaged in any process attempting to modulate the activity or biomarkers of at least one brain region and / or at least one brain network. In some embodiments, the EFP signal is based on an EEG measurement generated from EEG signals recorded from the subject, processed using a model (EFP) that allows correlation between EEG signals in a specific frequency band or several specific frequency bands over a specific time window recorded from a particular combination of electrodes and fMRI-BOLD activity of at least one specific brain region or at least one specific network.

[0295] According to some exemplary embodiments, the global baseline is based on or generated by at least one measure of central trend of the EFP or EEG signal measured in block 478. In some embodiments, the at least one measure of central trend includes at least one of the mean, median, and / or mode of the measured EFP or EEG signal. Optionally, a central trend can be extracted for each frequency band, corresponding to the frequency bands used to generate the EFP. In some embodiments, the global baseline is measured with the subject gazing at a fixed visual indicator, such as a fixed image of a cross, or with the subject's eyes closed until an audible signal indicating the end of the global baseline is played.

[0296] According to some exemplary embodiments, after optionally measuring a global baseline signal, one or more sessions of active NF 480 are administered to the subject. In some embodiments, each session 480 comprises a session 482 of active neurofeedback training. In some embodiments, the subject's condition is monitored in block 483 during one or more sessions 480, for example, during an active NF training 482. In some embodiments, the subject's condition is monitored and / or evaluated based on, for example, the subject's behavior during training 482, signals received from one or more sensors (e.g., optical sensors or EMG sensors), EEG signals measured from the subject's brain during training 482, and feedback received from a specialist, for example, a therapist monitoring the NF treatment session.

[0297] According to some exemplary embodiments, training 482 is modified based on the subject's condition assessed in block 483, for example, if the subject's condition assessment in block 483 indicates that the subject is not fully engaged in NF training 482 or is not interested in continuing training 482, training 482 is discontinued or shortened. Alternatively or additionally, training 482 is discontinued if the patient condition assessment in block 483 indicates that one or more symptoms of a mental disorder have appeared during training 482, and / or if the subject's cognitive and / or mental state is not a desired, e.g., target state when conducting training 482.

[0298] According to some exemplary embodiments, after the active NF session 480 is completed, the subject's state is optionally evaluated in block 484. In some embodiments, the subject's state is evaluated as described, for example, in block 472. In some embodiments, in block 484, the subject's state is optionally evaluated, for example, by comparing how and / or to what extent the active NF session performed in block 480 affected the subject's state with the subject's state evaluated in block 472.

[0299] According to some exemplary embodiments, in Block 486, suggestions, such as recommendations, are optionally made to the subject at the end of an NF treatment session. In some embodiments, the suggestions include suggestions regarding the next NF treatment session and / or activities outside the treatment center and / or activities between consecutive NF treatment sessions. Alternatively or additionally, suggestions provided in Block 486 include suggestions regarding the management of the treatment process outside the treatment center and / or after an NF treatment session, such as instructions on what to do if the subject experiences at least one symptom of a mental disorder and / or anticipates encountering a trigger for a mental disorder or a trigger for a symptom of a mental disorder.

[0300] Herein, we refer to Figure 4D, which shows an active training process performed in block 480 according to some exemplary embodiments of the present invention.

[0301] According to some exemplary embodiments, during an active NF session, for example, one or more NF training sessions or cycles 482 are performed for each NF treatment session shown in Figure 4C, and the subject receives any number of active NF training sessions 482, such as two, three, four, five, six, seven, eight, nine, ten, or more, according to a predetermined treatment plan or a modification thereof.

[0302] According to some exemplary embodiments, each active NF training cycle is optionally initiated by measuring a local baseline in block 488. In some embodiments, the local baseline measurement may be used to calculate a baseline or reference value for an EFP or EEG signal indicating activity or a biomarker of at least one brain region or brain network. In some embodiments, the local baseline is used optionally in a particular NF training cycle. Alternatively, one local baseline may be used as a reference for two or more local baselines in a single NF training cycle.

[0303] According to some exemplary embodiments, a local baseline is measured and set optionally when an interactive auditory / visual interface is presented to the subject, and an avatar is optionally displayed. In some embodiments, the auditory / visual interface is the interface used during NF training. In some embodiments, the subject is instructed to look at the interface and not to attempt to manipulate it. In some embodiments, during block 488, the interface does not respond to or to changes in EEG signals measured from the subject. In some embodiments, during block 488, no feedback is provided to the subject regarding the activity of at least one brain region or at least one brain network, for example, by modifying the interface in response to the determined activity of the brain region or brain network.

[0304] Alternatively, use measurements from the global baseline instead of the local baseline.

[0305] According to several exemplary embodiments, NF training takes place in block 490. In some embodiments, during NF training, the interface (e.g., auditory / visual interface) is modified in response to the activity of at least one brain region or brain network (optionally based on changes in EEG or EFP signals during training). In some embodiments, during NF training, the subject is instructed to attempt to modify the presented interface by applying one or more strategies, e.g., mental or cognitive strategies. In some embodiments, applying one or more mental strategies involves performing at least one cognitive or mental task while providing the subject with feedback, e.g., implicit feedback, regarding the activity of at least one brain region or brain network, for example, by modifying the auditory / visual interface. In some embodiments, during NF training in block 490, the subject is trained to modulate the activity of at least one brain region or brain network by applying strategies, e.g., strategies tailored to a specific subject. In some embodiments, the duration of blocks 488 and 490 is within the range of 30 seconds to 6 minutes, for example, within the range of 30 seconds to 2 minutes, within the range of 1 minute to 3 minutes, within the range of 2 minutes to 4 minutes, or within an intermediate range of time, a shorter range of time, or a longer range of time. In some embodiments, the duration of block 492 is within the range of 10 seconds to 3 minutes, for example, within the range of 10 seconds to 1 minute, within the range of 30 seconds to 2 minutes, or within an intermediate range of time, a shorter range of time, or a longer range of time.

[0306] According to several exemplary embodiments, a summary report is provided to the participant in block 492. In some embodiments, for example, the summary report block optionally presents the participant with a summary including a score for the training performed in block 492. In some embodiments, the score is calculated based on changes in the EFP or EEG signal measured during NF training in block 490, and optionally calculated relative to a local baseline measured in block 488. Optionally, the calculated score is a measure of the central trend of changes in the EFP or EEG signal during training in block 490 in a desired direction, such as upward or downward, and optionally a measurement relative to a local baseline measured in block 488.

[0307] Exemplary maintenance session According to some exemplary embodiments, one or more maintenance sessions, e.g., sessions 418 and 420, are conducted as part of the overall NF therapy 402, as shown, for example, in Figure 4A. In some embodiments, the maintenance sessions are configured to extend the therapeutic effects produced by the active neurofeedback therapy sessions or any other therapies performed on the patient during the NF therapy period 404. In some embodiments, the maintenance sessions are conducted outside the therapy center (e.g., when the subject is at home and / or engaged in daily activities). In some embodiments, the maintenance sessions are conducted using software installed on the subject's device, e.g., a personal device having at least one of a cellular communication device, mobile device, or tablet. In some embodiments, the subject's device includes a device 214, as shown in Figures 2 and 3B.

[0308] According to some exemplary embodiments, the maintenance session takes place while the subject's device is communicating with a remote device, such as the remote device 210 shown in Figures 2, 3A, and 3B, which contains the details of the maintenance session, such as one or more parameters. Alternatively, the maintenance session takes place while the personal device 214 is offline, for example, when it is not communicating with the remote device 210.

[0309] Herein, we refer to Figure 5, which illustrates the process for performing an NF maintenance session according to an exemplary embodiment of the present invention. In some embodiments, the NF maintenance session is performed by the control circuit of a device (e.g., device 214) using a set of instructions contained in maintenance software or a maintenance software application installed in the device's memory.

[0310] According to some exemplary embodiments, at least one of the parameter values, timing, and / or schedule of the maintenance session is predetermined, for example, according to the NF treatment plan. In some embodiments, the NF treatment plan is generated by a specialist and / or by a remote device, for example, remote device 210. In some embodiments, the NF treatment plan and / or maintenance session is individualized for a specific subject or group of subjects.

[0311] According to some exemplary embodiments, the subject receives, for example, a reminder from a device, such as a personal device, that maintenance is about to begin. In some embodiments, the subject can confirm whether or not they can attend the maintenance session, or they can reschedule the maintenance session. In some embodiments, when the subject reschedules the maintenance session, the maintenance software in device memory provides a new date and / or a new time for the maintenance session. Optionally, the maintenance software sends an update to a remote device along with the subject's decision and / or the new date and / or time for the maintenance session.

[0312] In some exemplary embodiments, in block 502, the subject's condition is optionally determined at the start of the maintenance session. In some embodiments, the subject's condition is determined to confirm that the subject's current condition is a desired or target condition, or that it has not deteriorated to a state where the maintenance session cannot be performed, in order to perform the maintenance session. In some embodiments, if the determined condition is not a desired condition, the maintenance session is rescheduled and / or an indicator is generated. In some embodiments, the indicator is transmitted to the expert and / or remote device 210. Alternatively, if the patient's condition is determined to be a desired condition, the maintenance session is started in block 504.

[0313] According to some exemplary embodiments, a maintenance session is initiated in block 504.

[0314] According to some exemplary embodiments, in block 506, during a maintenance session, an interface, for example, as a maintenance interface, is presented to the subject. In some embodiments, the maintenance interface includes an auditory interface and / or a visual interface.

[0315] In some embodiments, the device's control circuit presents an interface, optionally as part of the maintenance software, according to instructions and / or maintenance protocols installed in the device's memory. In some embodiments, the interface presented in block 506 is the same interface, or a variation thereof, used in an active NF training session, for example, session 482 shown in Figure 4C. Alternatively, the maintenance interface is a different interface from the one used in, for example, NF training session 482.

[0316] According to some exemplary embodiments, during the presentation of the maintenance interface, the device instructs the subject to apply a strategy used during NF training session 482 that enabled the subject to adjust the activity of at least one brain region or brain network in a desired direction. In some embodiments, instructions are provided to the subject in block 508 before the interface is presented to the subject in block 506.

[0317] According to some exemplary embodiments, block 510 optionally receives information from the subject, such as feedback signals. In some embodiments, the information is optionally received using the device's user interface, which is part of the maintenance software. Alternatively or additionally, the feedback signals are optionally received using one or more sensors of the device, such as optical sensors, and optionally a camera. Alternatively or additionally, the feedback signals are optionally received using one or more devices capable of communicating with the subject's device used in the maintenance session, such as sensors of a wearable device. In some embodiments, the feedback signals are received as described in Figure 3B, for example, showing devices 340 and 342 communicating with device 214. In some embodiments, subject feedback in block 510 is provided by the subject after they have been instructed to complete one or more questionnaires.

[0318] According to some exemplary embodiments, in block 506, a feedback signal is optionally received while the interface is presented to the subject or thereafter.

[0319] In some exemplary embodiments, the subject's state is determined as optional in block 512. In some embodiments, the subject's state is determined as optional based on feedback received in block 510. Alternatively, as previously described in block 456 shown in Figure 4B, the subject's state is determined as optional.

[0320] According to some exemplary embodiments, if the subject's state at the end of a maintenance session is not a desired state, e.g., a target state, an indicator is generated in block 518. Optionally, the indicator is sent to a remote device. Alternatively or additionally, at least one new NF therapy session, e.g., at least one booster session, e.g., booster sessions 422 and 424, is scheduled. Alternatively or additionally, in block 522, at least one new maintenance session is scheduled.

[0321] According to some exemplary embodiments, in block 516, if the subject's state at the end of the maintenance session is not a desirable state, for example, a target state, in block 524, a new interface is presented to the subject, and the same strategy is instructed to the subject, and the maintenance session is repeated. Alternatively, in block 526, a new interface is presented to the subject, and a new strategy is instructed to the subject, thereby repeating the maintenance session. Alternatively, in block 528, an interface similar to that in block 506 is presented to the subject, and a new strategy is instructed to the subject, thereby repeating the maintenance session.

[0322] Optionally, if the subject's condition is not in the target state, modify the presented interface and / or the strategies applied during the maintenance session when scheduling a new maintenance session.

[0323] Exemplary electrical fingerprint (EFP) Compared to functional magnetic resonance imaging (fMRI), which is used to detect bold activity in brain regions, electroencephalography (EEG) constitutes a far more scalable recording device. However, because EEG has low spatial resolution, it cannot detect activity originating from deep brain regions such as the limbic system, the positive and negative valence systems, for example.

[0324] To combine the advantages of both measurement methods (fMRI and EEG), a tool was developed to predict fMRI bold activity in specific deep brain regions (e.g., the amygdala) based solely on EEG. After simultaneously recording EEG and fMRI signals, advanced data alignment and statistical techniques were applied to the recorded signals to correlate the data from both modalities. As a result, a predictive model (also known as EFP) was obtained that allows EEG signals to be converted into surrogate indicators of bold fMRI signals in specific brain regions. The EFP for the amygdala is described in International Patent Application Publication No. 2012104853A2, which is incorporated herein by reference. The EFP for the ventral striatum is described in International Patent Publication No. 2021260697A1, which is incorporated herein by reference.

[0325] According to some exemplary embodiments, the EFP model is a weighted coefficient matrix of at least 100 coefficients, optionally for the EEG converted to time delay × frequency, derived from the statistical correlation between concurrently acquired EEG and fMRI recordings having a Volume of Interest (VOI) covering a specific brain region. In some embodiments, the coefficient matrix is ​​associated with frequency bands, electrodes, and one or more time windows.

[0326] For example, the EFP of the ventral striatum includes electrical signals such as EEG electrical signals recorded from EEG electrodes located at positions C4, F7, F8, T7, T8, P8, TP9, and TP10. In some embodiments, the EFP includes EEG electrical signals in the frequency range of 0 Hz to 40 Hz and is contained within a time delay window of 0 to 30 seconds. Alternatively, the EFP of the ventral striatum consists of electrical signals recorded from EEG electrodes located at positions C4, C3, Cz, P3, P4, and Pz, filtered with a 0.5 Hz to 40 Hz bandpass filter, and has a time delay window of 0 to 13.1 seconds.

[0327] Example EFP signal Here, we refer to Figure 6A illustrating the generation of EFP signals according to some exemplary embodiments of the present invention. In Figure 6A, the generation of an amygdala EFP signal that predicts BOLD activity in the amygdala is illustrated using an amygdala EFP model. Similarly, the generation of other signals that predict BOLD activity in other brain regions, such as deep brain regions, can be performed in a similar manner using EFP models specific to those brain regions.

[0328] According to some exemplary embodiments, during an active NF session, for example session 482, a dynamic auditory / visual interface 604 is displayed to the subject 606. Optionally, the subject 606 is instructed to modify the dynamic auditory / visual interface 604, for example, by applying at least one strategy, or by performing at least one cognitive and / or mental task on their own.

[0329] According to some exemplary embodiments, optionally, electrical signals are recorded by one or more electrodes 608 located on the subject's head while the dynamic auditory / visual interface 604 is displayed to the subject 606. In some embodiments, the electrodes are electrodes 316, 318 shown in Figure 3A.

[0330] 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 signal.

[0331] According to some exemplary embodiments, EEG features 612 are extracted from the raw EEG signal 610. In some embodiments, the EEG features include frequency bandwidths and electrode-by-electrode time delays. Optionally, the features and intensities are arranged in a matrix.

[0332] According to some exemplary embodiments, EEG features and their intensities are multiplied by the weights of the EFP model 602 to calculate an EFP signal 614 that predicts the bold activity of a particular brain region or a particular network. Optionally, the particular brain region is part of a particular brain network.

[0333] According to some exemplary embodiments, the NF device, for example, the control circuit of the NF device, is configured to modify at least one parameter of interface 604 in response to changes in the calculated EFP signal 614. In some embodiments, the modification of interface 604 provides feedback to the subject 606 regarding the activity of at least one brain region or at least one brain network. Alternatively or additionally, the modification of interface 604 provides feedback to the subject 606 regarding their ability to modulate the activity of at least one brain region or at least one brain network.

[0334] Exemplary Active NF Cycle Refer to Figure 6B, which shows an active NF cycle process according to some exemplary embodiments of the present invention.

[0335] According to some exemplary embodiments, one or more active NF cycles are performed during an NF treatment session, for example, active NF cycle 482 as described in Figures 4C and 4D.

[0336] According to several exemplary embodiments, a global baseline is measured in each active NF cycle or at least once during an NF therapy session. In some embodiments, the global baseline measurement phase 620 involves recording static EEG data, for example, with the subject presented with a white asterisk on a black screen. Alternatively, the subject is presented with a non-dynamic interface and / or an interface that is not related to the subject's mental disorder and / or cannot induce one or more symptoms of that disorder. In some embodiments, the EEG is then preprocessed to remove noise artifacts.

[0337] In some embodiments, after noise artifact removal, a stockwell transform is applied and the output is resampled in both the time and frequency domains (4 Hz up to 250 Hz, and 9-10 frequency bands). In some embodiments, for the remainder of the NF treatment session, a measure of central tendency can be calculated and stored, for example, as an average value for each frequency band, and optionally used to center the time-frequency transformed EEG signal when calculating the EFP signal.

[0338] According to some exemplary embodiments, after measurement of a global baseline, a dynamic feedback interface, such as an animated feedback interface, is presented to the subject N times, for example, at least twice. In some embodiments, the number of times the dynamic feedback interface is presented to the subject is 3, 4, 5, 6, 7, 8, or any number more, and the subject repeats cycles of "resting" when instructed not to attempt to adjust the dynamic feedback interface, and "adjusting" when instructed to attempt to adjust the dynamic feedback interface, optionally by applying mental or cognitive strategies.

[0339] According to some exemplary embodiments, during the “resting” phase, e.g., phases 622, 622, and 628, EEG data is recorded while the subject observes a dynamic feedback interface. This interface does not respond to or modify changes in the EEG signal, e.g., the EFP signal, during this phase (i.e., there is no feedback). Optionally, a local baseline 622 is measured (e.g., calculated) during the “resting” phase 622. In some embodiments, for this phase, the EFP value is calculated by calculating a resampled stockwell transform, subtracting the mean value calculated from the signal acquired during the global baseline phase, and multiplying by the weights of an EFP model, e.g., EFP model 602.

[0340] In some exemplary embodiments, during an active feedback phase 626 called “adjustment,” EFP values ​​are calculated in the same manner as described above with respect to the “rest” phase 622. In some embodiments, summary statistics (mean and standard deviation) of the EFP values ​​calculated during “rest” are then used to calculate the change in the EFP signal calculated between “adjustment” and “rest.” In some embodiments, this calculated change in the EFP signal is then reflected to the subject as a change in a dynamic feedback interface, such as an audiovisual interface of animation.

[0341] According to some exemplary embodiments, the duration of the global baseline measurement phase 620 is in the range of 5 seconds to 5 minutes, for example, in the range of 1 minute to 5 minutes, in the range of 2 minutes to 4 minutes, or an intermediate, shorter or longer period.

[0342] According to some exemplary embodiments, the duration of the local baseline measurement phase 622, for example, the “rest” phase 622, is in the range of 5 seconds to 5 minutes, for example, in the range of 1 minute to 5 minutes, in the range of 30 seconds to 2 minutes, or an intermediate, shorter or longer duration.

[0343] According to some exemplary embodiments, the duration of the active NF phase 626 is in the range of 5 seconds to 5 minutes, for example, in the range of 1 minute to 5 minutes, in the range of 30 seconds to 2 minutes, or an intermediate, shorter or longer time.

[0344] According to some exemplary embodiments, the duration of the “rest” phase 628 at the end of NF phase 626 may be, for example, in the range of 5 seconds to 2 minutes, 1 minute to 5 minutes, 30 seconds to 2 minutes, or other intermediate, shorter or longer durations.

[0345] Monitoring the quality of an example signal According to some exemplary embodiments, after one or more electrodes are attached to the subject's body, for example, the subject's head, the quality of the signals recorded by the electrodes is determined. In some embodiments, the signal quality is determined before initiating an NF therapy session, and the signal quality is monitored during the NF therapy session to confirm, for example, that the signal quality is sufficient to perform the NF therapy session. In some embodiments, the system automatically terminates the NF therapy session if the signal quality is insufficient. Alternatively, the system provides instructions or suggestions to terminate the NF therapy session and / or provides instructions or suggestions on how to improve the signal quality.

[0346] In some embodiments, "signal quality" and its derivatives correlate with the level of noise signal recorded by the electrodes. Electrodes that record high-quality signals introduce less noise into the recorded signal.

[0347] According to some exemplary embodiments, signal quality is determined and monitored for each electrode located on the subject's head. In some embodiments, the NF system, e.g., the NF system 302 shown in Figure 3A, or NF device, provides feedback to the subject or a professional, e.g., a supervisor, regarding the signal quality of each electrode or all electrodes. Optionally, the feedback information is color-coded feedback and / or a value indicating the quality level of the recorded signal or the suitability of at least one electrode used during an NF treatment session. Optionally, the system provides the user with suggestions for improving signal quality.

[0348] According to some exemplary embodiments, the signal quality recorded by one or more electrodes, or all electrodes, is determined relative to an absolute reference value, or to the absolute minimum and absolute maximum values ​​of a reference range. Alternatively or additionally, the signal quality recorded by one or more electrodes, or all electrodes, is determined relative to at least one selected electrode that records a signal of a target quality level. In some embodiments, the system determines signal quality in at least one first step in which the signal quality recorded by each electrode is determined relative to at least one absolute reference value, and at least one second step in which the recorded signal quality is determined relative to the signal recorded by at least one selected electrode that exhibits a target quality level. Alternatively or additionally, the signal quality is determined relative to a predetermined range of values ​​related to at least one parameter of the signal recorded from the selected at least one electrode having a target quality level.

[0349] According to some exemplary embodiments, the signal quality of an electrode is determined relative to a selected signal from a particular electrode. In some embodiments, the selected signal has a target signal peak-to-peak and, optionally, the highest signal peak-to-peak relative to other measured signals from other different electrodes. Alternatively or additionally, signal quality is determined absolutely, for example, with respect to a predetermined reference value or range.

[0350] According to some exemplary embodiments, the signal quality of an electrode is determined relative to a selected signal range from a particular electrode. In some embodiments, the selected signal optionally has a target signal range within twice the range of the highest signal peak-to-peak measured from different electrodes. Alternatively or additionally, the signal quality is determined absolutely, for example, against predetermined maximum and / or minimum reference values.

[0351] Here, we refer to Figure 7A illustrating a general process for determining signal quality according to some exemplary embodiments of the present invention.

[0352] According to some exemplary embodiments, in block 700, signals are recorded by electrodes positioned on the subject's body surface, for example, on the subject's head. In some embodiments, the signals are electrical signals recorded by electrodes, for example, electrodes 316, 318 shown in Figure 3A.

[0353] In some exemplary embodiments, the EEG signal is measured in block 701. In some embodiments, the EEG signal is measured from the electrical signal recorded in block 700.

[0354] According to some exemplary embodiments, the EEG signal is preprocessed in block 703. In some embodiments, the preprocessing of the EEG signal includes filtering the EEG signal. In some embodiments, for example, to remove line noise from the measured signal, the signal is filtered using a bandpass filter with a frequency of 49 Hz to 51 Hz. The filtered signal, or the measured signal, is then further filtered using, for example, a 0.1 Hz to 10 Hz filter, a 1 Hz to 30 Hz filter, a 0.5 Hz to 20 Hz filter, a 1 Hz to 40 Hz filter, or a bandpass filter with an intermediate, smaller, or larger frequency range.

[0355] According to some exemplary embodiments, in block 705, electrodes used to record a selected signal are identified. In some embodiments, the selected signal has the highest peak value, or a target peak value, e.g., a desired peak value.

[0356] According to some exemplary embodiments, the system or a user of the system sets a range of peak values ​​relative to a target peak value in block 707. In some embodiments, the target range includes peak values ​​that are at least 50% of the target peak value, for example, at least 60%, at least 70%, at least 80%, at least 90%, at least 95% of the peak value of a selected signal identified in block 705, or any intermediate percentage value or range value, a smaller percentage value or range value, or a larger percentage value or range value.

[0357] According to some exemplary embodiments, the system determines in block 709 which electrodes generate signals within the target range determined in block 707.

[0358] According to some exemplary embodiments, the system generates and provides an index relating to the determination result in block 711. In some embodiments, the index includes information about at least one electrode that generates a signal outside a predetermined range, and / or information about at least one electrode that generates a signal within a predetermined range. In some embodiments, the index is a human-detectable index, optionally a visually recognizable index, and optionally a color-coded index. In some embodiments, the index includes instructions for improving the signal generated by one or more electrodes that generate a signal outside a target range, thereby bringing the generated signal within a predetermined range of the target.

[0359] According to some exemplary embodiments, the system initiates NF therapy in block 713. In some embodiments, the system initiates NF therapy by measuring EEG signals and, based on the measured EEG signals, transmitting feedback signals to the patient, e.g., the trainee, indicating the activity or change in the activity of at least one specific brain region or at least one specific brain network. In some embodiments, the system initiates NF therapy after a sufficient number of electrodes have generated EEG signals within a predetermined range set in block 707.

[0360] According to some exemplary embodiments, during NF treatment, a signal is measured by an electrode in block 715. In some embodiments, a signal such as an EEG signal is measured by the electrode determined in block 709, and a signal of sufficient quality is generated.

[0361] According to some exemplary embodiments, a minimum signal peak threshold is set in block 717.

[0362] According to some exemplary embodiments, during NF treatment, the system provides an index in block 719 based on the relationship between the measured signal peak and a minimum signal peak threshold. In some embodiments, the system determines that the signal quality is low or insufficient if the signal peak value is below the threshold. In some embodiments, the system determines that the signal quality is good or sufficient if the signal peak value is above the threshold. In some embodiments, the index is a human-detectable index. In some embodiments, the index is a visual index. Optionally, the index is a color-coded index.

[0363] In some exemplary embodiments, the quality of a signal is evaluated by determining the relationship or function of the signals measured between two electrodes or in any group of electrodes with respect to a reference value for each signal.

[0364] Herein, we refer to Figure 7B illustrating a process for determining the signal quality recorded from one or more electrodes according to some exemplary embodiments of the present invention. In some embodiments, this process can evaluate the electroencephalogram (EEG) signal quality in real time during data acquisition and optionally issue an alert if the acquisition quality is low.

[0365] According to some exemplary embodiments, EEG data is provided in block 702. In some embodiments, the EEG data is provided as a stream from one or more electrodes at a predetermined sample rate, for example, in the range of 50 Hz to 1000 Hz (e.g., 100 Hz, 128 Hz, 250 Hz, 256 Hz, 500 Hz, 512 Hz), or at intermediate, smaller or larger sample rate frequencies. In some embodiments, the EEG data stream (e.g., amplitude in μV units per sample) is provided from eight electrodes at a sample rate of 250 Hz. In some embodiments, the EEG data is provided in blocks of 1, 2, 3, 5, 10, 30, 60, 120, 180 seconds and intermediate, smaller and larger values, for signal quality evaluation.

[0366] According to some exemplary embodiments, in block 704, the received stream is collected in an EEG data buffer. In some embodiments, the buffer includes the most recent portion of the EEG stream for up to 100 seconds, for example, up to 80 seconds, up to 60 seconds, up to 40 seconds, up to 20 seconds, or up to 10 seconds.

[0367] According to some exemplary embodiments, in block 706, one or more predetermined frequency band filters are applied to the EEG data buffer. In some embodiments, the filters decompose the EEG signal into artifact-specific time series whose size is electrode × buffer length.

[0368] According to some exemplary embodiments, in order to avoid edge effects when applying a frequency filter, the second-to-last 1-second EEG is extracted from the filtered buffer and the following steps are optionally applied. a. In block 708, for each bandwidth, the selected number of seconds or sequence of seconds (parameter) (e.g., 3 seconds, 5 seconds, or any sequence of seconds (parameter)) is divided into 2 (parameter) intervals, and the amplitude range of each interval is compared to a predefined absolute threshold calculated on a large sample of data. If the amplitude range for a specified portion of the interval falls within the range of the pre-calculated threshold, the extracted number of seconds or sequence of seconds is classified as "good" (1). b. For specific frequency bands (e.g., power line noise between 49 and 51 Hz), a relative threshold is added to (a), which is the amplitude ratio of each channel to the channel with the smallest peak-to-peak amplitude within the time window of interest (block 710). Optionally, this can be done in block 712 for specific electrodes within a time limit. For example, for a specific time window of up to 180 seconds from the start of the EEG recording, only the EFP model electrode is classified as "good" if both the absolute and relative thresholds are met. Otherwise, in block 722, the time interval is classified as "unsuitable". Optionally, in block 714, only (a) is applied for classification for the remainder of the EEG recording.

[0369] In some exemplary embodiments, in block 716, the above classification per second is reduced to a time window ranging from 10 to 60 seconds, representing the most recently acquired signal from each channel, such as a 30-second moving average. In some embodiments, in block 718, step by step (one second or part thereof, or any different time intervals), the moving average is assigned a score ranging from "acceptable" (greater than a predetermined value, e.g., 0.85) to "error" (less than a predetermined value, e.g., 0.1), depending on the proportion of "good" time points within the window. Then, in block 720, the scoring categories can be presented in a visualization of the electrode layout to guide the device operator to improve the signal of the poor channel.

[0370] Herein, we refer to Figure 7C, which shows a feedback interface that provides an index of signal quality for each electrode, according to some exemplary embodiments of the present invention.

[0371] According to some exemplary embodiments, the signal quality interface 750 includes a color-coded index, optionally using a graphical representation of the electrode's position on the head, for at least one index relating to the signal quality per electrode, for example, the signal quality per electrode coupled to the subject's head. In some embodiments, electrodes recording signals of sufficient quality are shown in green, and optionally the electrode's position in the EEG coordinate system is also shown in green (e.g., electrode 752). In some embodiments, electrodes with insufficient signal quality, such as electrode 754, are shown in red. In some embodiments, electrodes recording signals of intermediate quality, such as electrode 756, are shown in orange.

[0372] According to some exemplary embodiments, in a visual interface, each electrode is noted for recording a signal of sufficient quality (optionally with the note "good"), for recording a signal of insufficient quality (optionally with the note "unsuitable"), or for not recording a signal or for recording a signal of insufficient quality (optionally with the note "error").

[0373] According to some exemplary embodiments, if all or most electrodes are in the “error” range (marked with “error” and optionally colored red), the visual interface displays only the ground and reference electrodes, optionally showing instructions and / or guidelines for prioritizing the handling of these electrodes, as these electrodes may optionally have a significant impact on the overall quality of the acquisition. In some embodiments, the operator should attempt to highlight the signals from the remaining electrodes after addressing the ground and reference electrodes.

[0374] According to some exemplary embodiments, the signal quality interface includes instructions on how to improve the signal quality recorded by one or more electrodes. In some embodiments, the signal quality interface includes a graphical representation of the EEG signals recorded by each electrode, for example, in the form of graph 758 or a series of graphs.

[0375] Here, we refer to Figure 7D, which illustrates an additional process for determining signal quality according to some exemplary embodiments of the present invention.

[0376] According to some exemplary embodiments, in block 721, signals are recorded by electrodes positioned on the subject's body surface, for example, on the subject's head. In some embodiments, the signals are electrical signals recorded by electrodes, for example, electrodes 316 and 318 shown in Figure 3A.

[0377] According to some exemplary embodiments, the EEG signal is measured in block 723. In some embodiments, the EEG signal is measured from the electrical signal recorded in block 721.

[0378] According to some exemplary embodiments, the EEG signal is preprocessed in block 725. In some embodiments, the preprocessing of the EEG signal includes filtering the EEG signal. In some embodiments, the signal is filtered, for example, with a bandpass filter with a frequency of about 49.9 Hz to about 50.1 Hz to evaluate the line noise of the measured signal. Alternatively, the measured signal may be filtered with, for example, a bandpass filter of about 0.1 Hz to about 10 Hz, a filter of about 1 Hz to about 30 Hz, a filter of about 0.5 Hz to about 20 Hz, a filter of about 1 Hz to about 40 Hz, or a bandpass filter of about 2 Hz to about 40 Hz in an intermediate, smaller or larger frequency range.

[0379] According to some exemplary embodiments, in block 727, at least one electrode and at least one preprocessed signal are selected and identified. In some embodiments, the selected signal is a preprocessed signal (a signal resulting from preprocessing performed in block 725) that has been filtered using a bandpass filter, for example, as described in block 725. In some embodiments, the selected at least one electrode is an electrode that records the selected at least one preprocessed signal.

[0380] According to some exemplary embodiments, the system or a user of the system sets a target range of peak-to-peak values ​​for a target peak-to-peak value in block 729. In some embodiments, the target range is defined by the maximum and minimum peak-to-peak values, and the selected preprocessed signal identified in block 727 must remain within this target range of peak-to-peak values ​​for a predetermined percentage of time. Optionally, the signal is ensured not to exceed the maximum value and not to fall below the minimum value for, for example, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the time of the selected signal, or any smaller or larger percentage in between.

[0381] According to some exemplary embodiments, the system determines in block 731 which electrodes generate signals within the target range defined in block 729.

[0382] According to some exemplary embodiments, the system generates and provides an index relating to the determination result in block 733. In some embodiments, the index includes information about at least one electrode that generates a signal that is not within a predetermined peak-to-peak range, and / or information about at least one electrode that generates a signal within a predetermined peak-to-peak range. In some embodiments, the index is a human-detectable index, optionally a visually recognizable index, and optionally a color-coded index. In some embodiments, the index includes instructions for improving the signal generated by one or more electrodes that generate a signal outside the target range, so that the generated signal falls within a predetermined peak-to-peak range of the target.

[0383] According to some exemplary embodiments, the system initiates NF therapy in block 735. In some embodiments, the system initiates NF therapy by measuring EEG signals and, based on the measured EEG signals, transmitting feedback signals to the subject, e.g., the trainee, indicating the activity or change in the activity of at least one specific brain region or at least one specific brain network. In some embodiments, the system initiates NF therapy only after a sufficient number of electrodes, or a predetermined subgroup of electrodes, have generated EEG signals within a predetermined peak-to-peak range set in block 729. In some embodiments, the predetermined electrode group may comprise electrodes that are required to be positioned at specific locations on the subject's head to record EEG signals indicating the activity or change in the activity of at least one specific brain region or at least one specific brain network.

[0384] According to some exemplary embodiments, in block 737, signals recorded by each electrode are monitored during NF treatment. In some embodiments, signals, such as EEG signals, are monitored to determine whether they meet the criteria defined in block 729. In some embodiments, the monitoring of the signals includes monitoring the peak-to-peak range of the signals. In some embodiments, the monitoring includes determining that the signal peak-to-peak values ​​are within the peak-to-peak range defined in block 729, within a partial range of the peak-to-peak range, or within a range wider than the defined peak-to-peak range.

[0385] According to some exemplary embodiments, during NF treatment, the system provides an index in block 739 based on the relationship between the measured signal and the desired target signal. In some embodiments, the system determines that the signal quality is poor or insufficient if the monitored signal is not included in the target peak-to-peak range, the target sub-range, or the derived target range, as described in block 737. In some embodiments, the system determines that the signal quality is good or sufficient if the monitored signal is included in the target peak-to-peak range, the target sub-range, or the derived target range. In some embodiments, the index is a human-detectable index. In some embodiments, the index is a visual index. Optionally, the index is a color-coded index. Optionally, the system provides an index for insufficient quality of at least one signal measured by one or more electrodes, or interrupts treatment before or after providing an index. In some embodiments, when the signal quality has improved to a sufficient level, the process is optionally or automatically resumed.

[0386] In some exemplary embodiments, the quality of a signal is evaluated by determining the relationship or function of the signals measured between two electrodes or in any group of electrodes to each signal or to a reference value.

[0387] Herein, we refer to Figure 7E illustrating an additional process for determining the signal quality recorded from one or more electrodes according to some exemplary embodiments of the present invention.

[0388] In some embodiments, this process allows for real-time evaluation of EEG signal quality during data acquisition and optionally triggers an alert if the signal quality is lower than the target signal quality required to obtain reliable measurements of activity in at least one brain region, activity in at least one brain network, or activity or changes in activity in at least one brain system.

[0389] According to some exemplary embodiments, EEG data is provided in block 741. In some embodiments, the EEG data is provided as a stream from one or more electrodes at a predetermined sample rate in the range of 50 Hz to 1000 Hz, e.g., 100 Hz, 128 Hz, 250 Hz, 256 Hz, 500 Hz, 512 Hz, or an intermediate, smaller, or larger range of sample rates. In some embodiments, the EEG data stream (e.g., amplitude in μV per sample) is provided from at least one electrode, or for example, two or more electrodes, e.g., two, four, six, eight, ten, or an intermediate number, or more electrodes, at a sample rate in the range of approximately 50 Hz to approximately 1000 Hz (e.g., approximately 100 Hz, approximately 128 Hz, approximately 250 Hz, approximately 256 Hz, approximately 500 Hz, approximately 512 Hz, or an intermediate, smaller, or larger range of sample rate frequencies).

[0390] In some embodiments, EEG data is provided, for example, for signal quality evaluation, in time blocks of at least 1 second, such as 1, 2, 3, 5, 10, 30, 60, 120, 180 seconds, or any intermediate smaller or larger value.

[0391] According to some exemplary embodiments, in block 743, the received stream is collected in an EEG data buffer. In some embodiments, the buffer contains, for example, 100 seconds, 80 seconds, 60 seconds, 40 seconds, 20 seconds, 10 seconds, or a series of smaller or larger epochs of the most recent portion of the EEG stream.

[0392] According to some exemplary embodiments, in block 745, one or more predetermined frequency band filters are applied to the EEG data buffer. In some embodiments, the filters decompose the EEG signal into time series of artifacts of electrode × buffer length size, optionally generating multiple EEG epoch segments in different frequency bands. For example, line noise artifacts are evaluated by filtering the signal with a bandpass filter with frequencies from about 49.9 Hz to about 50.1 Hz. Alternatively or additionally, blink artifacts are evaluated by filtering the signal with a bandpass filter with frequencies from about 0.5 Hz to about 12 Hz.

[0393] According to some exemplary embodiments, for example, to avoid edge effects when a frequency filter is applied, the second most recent 1-second EEG, optionally the second most recent EEG epoch, is extracted from the filtered buffer, and the following steps are optionally applied.

[0394] a. In block 749, for each bandwidth, the selected number of seconds or sequence of seconds (parameter) (e.g., an epoch containing 3 seconds, 5 seconds, or any number of seconds) is divided into 2 (parameter) intervals, and the amplitude range of each interval is compared to a predefined absolute threshold or range of values ​​optionally calculated based on a large sample of data. If the amplitude range for a specified portion of the interval falls within the pre-calculated threshold range, the extracted number of seconds or sequence of seconds is classified as "good" (1). For example, the comparison is made for peak-to-peak for each segment against the minimum and maximum absolute threshold values. For example, a peak-to-peak from 2Hz to 40Hz is taken and checked to see if it falls within the amplitude threshold range of 5 to 100 in microvolts.

[0395] b. In some embodiments, block 751 optionally provides a relative threshold for epochs in a specific frequency band, such as power line noise (e.g., approximately 49.9 to 50.1 Hz or approximately 59.9 to 60.1 Hz, depending on the power grid frequency in the region). In some embodiments, the relative threshold includes two additional criteria in addition to (a). Optionally, the filtered EEG epoch segments should satisfy one of the following conditions: for example, the peak-to-peak amplitude should not exceed twice the channel with the smallest peak-to-peak amplitude, and / or the filtered EEG epoch segments should be less than 30% of the range within the filter window. In some embodiments, these parameters were selected based on the analysis of a large dataset of EEG recordings. Optionally, satisfying one or more predetermined conditions is performed for an epoch within a time limit and applied to each specific electrode used for recording the EEG epoch (for example, for each selected electrode associated with the EFP model (e.g., C4, F7, F8, T7, T8, P8, TP9 and TP10, and / or one or more electrodes located at positions C4, C3, Cz, P3, P4 and Pz) within a specific time window up to 180 seconds from the start of the EEG recording). In some embodiments, one second or more of the EEG is classified as "good" only if both absolute and relative thresholds are met. Otherwise, in block 747, the EEG epoch is classified as "poor". Optionally, in block 753, only (a) is applied to the remainder of the EEG recording to classify each second, the average of the seconds, or the entire epoch as "good" or "poor" signal quality.

[0396] c. Alternatively, the relative mechanisms outlined in (b) could substitute for what was decided in (a), allowing the system to adopt a more relaxed approach rather than a strict one in block 755.

[0397] According to some exemplary embodiments, the above classification per second is narrowed down, for example in block 757, to a range of, for example, a 30-second moving average time window (EEG epoch), e.g., between approximately 3 seconds and approximately 60 seconds, representing the most recent acquired signal from each channel (e.g., each electrode). In some embodiments, block 759 scores the moving average step by step (one second or part thereof, or any different time intervals) from "acceptable" (a predetermined value, e.g., above 0.85) to "error" (a predetermined value, e.g., below 0.1), depending on the proportion of "good" time points within the window. In some embodiments, the scoring indicators, e.g., values, categories, and / or notes, are provided via a user interface to the subject receiving NF treatment and / or the supervisor of the NF treatment. Optionally, the scoring indicators are provided, for example, in block 761, using a graphical representation of the electrode layout visualization, to guide the device operator / supervisor to improve the signals recorded in channels annotated, e.g., "poor".

[0398] For example, as shown in Figure 7F, three EEG signals (i.e., signal 780 recorded by the electrode at position PZ, signal 782 recorded by the electrode at position FCZ, and signal 784 recorded by the electrode at position CZ) are recorded on the subject's scalp by different electrodes. In some embodiments, the electrode positions follow a 10-20 coordinate system or an extended 10-20 coordinate system.

[0399] According to some exemplary embodiments, the EEG signals 780, 782, and 784 are filtered through a bandpass filter with a frequency range of approximately 2 Hz to approximately 40 Hz. In some embodiments, each signal is divided into segments (e.g., epochs of a predetermined time). In some embodiments, the peak-to-peak value is the absolute difference between the maximum amplitude, e.g., maximum amplitude value 786, and the minimum amplitude, e.g., minimum amplitude value 788.

[0400] According to some exemplary embodiments, the peak-to-peak value, or average value, of each signal in each epoch is compared to an absolute threshold, such as an absolute amplitude threshold. Optionally, the absolute amplitude threshold is predetermined and optionally a range of values. In some embodiments, the amplitude or average amplitude of each signal in each epoch is compared to an absolute threshold of approximately 5 μV (microvolts) to approximately 100 μV.

[0401] For example, the peak-to-peak values ​​measured per epoch, or their average values, were approximately 70 for electrode PZ (position PZ where signal 780 is recorded), approximately 200 for electrode FCZ, and approximately 40 for electrode CZ. The measured peak-to-peak values ​​are then compared to an absolute threshold of approximately 5 μV (microvolts) to approximately 100 μV. In this example, signals 780 and 784 are within the absolute threshold, while signal 782's peak-to-peak value exceeds the upper limit of the threshold. Therefore, only signals 780 and 784 meet the absolute threshold.

[0402] In some embodiments, the fit of the recorded signal to a relative threshold is checked, and optionally, the fit of only signals that fit to an absolute threshold is checked. In the provided example, the electrode with the smallest peak-to-peak value is electrode CZ, whose peak-to-peak value or average is 40. In some embodiments and the above provided example, the relative threshold is set based on the peak-to-peak value of the electrode with the smallest peak-to-peak value. In some embodiments, the relative criterion, e.g., the relative threshold, is set to, for example, up to 1.1 times, up to 1.5 times, up to 2 times, up to 2.5 times, up to 3 times, or any intermediate, smaller or larger value of the peak-to-peak value of the electrode with the smallest peak-to-peak value.

[0403] In this example, optionally, the peak-to-peak value of the signal measured at electrode PZ for each epoch, or its average value, is compared to a relative threshold based on the peak-to-peak value of electrode CZ (best electrode signal). For example, the relative threshold could be that the peak-to-peak value of the signal recorded at each electrode does not exceed twice the best electrode peak-to-peak value (40 × 2 = 80 microvolts in this example). Electrode PZ exceeds the relative threshold based on the provided example.

[0404] Optionally, if the relative threshold is slightly above the lower limit of the absolute threshold, for example, if the relative threshold is up to 3 times, 4 times, 5 times, 6 times, or an intermediate, smaller, or larger value of the lower limit of the absolute threshold (if the lower limit is 5 μV, then 3 times is 15, 4 times is 20, and 5 times is 25), a second absolute threshold is applied. In some embodiments, the second absolute threshold is a percentage of the peak-to-peak value of the signal recorded at each electrode that is 5%, 10%, 15%, 20%, 25%, 30%, 35%, or an intermediate, smaller, or larger value of the peak-to-peak value of the higher absolute threshold (for example, 30% of 100 is 30).

[0405] In some embodiments, the comparison of peak-to-peak values ​​with absolute and / or relative thresholds is repeated for the peak-to-peak values ​​of the signal in each epoch and for each electrode.

[0406] According to several exemplary embodiments, each signal epoch is classified based on the level of fit to an absolute threshold, a relative threshold, and optionally a second absolute threshold, for example, before and / or during the implementation of a biofeedback process, such as a neurofeedback process. In some embodiments, the classification includes calculating a fit score for each signal epoch, indicating the level or percentage of fit of the signal to the absolute threshold and / or relative threshold in each epoch. In some embodiments, the supervisor of the biofeedback process is provided with human-detectable indicators, such as auditory and / or visual indicators using an auditory and / or visual interface, optionally. For example, in some embodiments, if the fit score is at least 0.7 (70%), the epoch is classified as “good,” optionally meaning that the recorded signal in the epoch is of sufficient quality to perform the biofeedback process. For example, in some embodiments, if the fit score is between approximately 0.4 (40%) and approximately 0.7 (70%), or any sub-range, the epoch is classified as “medium,” optionally meaning that the recorded signal in the epoch is of insufficient quality. For example, in some embodiments, if the conformance score is between 0.1 and 0.4, the epoch is classified as "poor," which optionally means that it falls below the minimum quality required to perform the biofeedback process. For example, in some embodiments, if the conformance score is less than approximately 0.1, the epoch is classified as "error," which optionally means that there are errors in the recording of signals during the epoch.

[0407] According to some exemplary embodiments, the division into epochs, determination of the suitability of the signal thresholds by absolute thresholds, relative thresholds, and optionally a second absolute threshold, calculation of suitability scores, classification of epochs based on the suitability scores, and generation of human-detectable indices based on the classification are repeated using a moving window along the recorded signal before and / or during the biofeedback process.

[0408] According to some exemplary embodiments, the generated signal quality index indicates or instructs to improve contact between the electrode and the subject if the signal quality is classified as “error,” “poor,” and / or “medium.”

[0409] According to some exemplary embodiments, as shown in Figures 7A to 7F, the determination of signal quality and / or whether the electrodes are recording the signal with sufficient quality is performed by the system 302, control circuit 310, and / or any control circuit that is part of the system 302, or an NF device, as described herein.

[0410] Exemplary expert interface for NF training According to some exemplary embodiments, during an NF therapy session, a professional, such as a supervisor, receives indicators from the NF system regarding the progress of the NF therapy session. Optionally, the NF system provides the professional with information, for example, about the subject's mental and / or cognitive state. In some embodiments, the NF training professional interface includes visual indicators of an audiovisual interface presented to the subject by the NF system, and / or, optionally, indicators of changes in the EFP signal relative to a reference or baseline value, as an option in graph form.

[0411] Refer to Figure 8A, which shows a global baseline expert interface according to some exemplary embodiments of the present invention.

[0412] According to some exemplary embodiments, the global baseline interface 800 includes one or more of the following: an indicator 802 for the time remaining in the entire session or in this particular session; an indicator 804 (e.g., a graphical representation or actual view of the interface displayed to the trainee, optionally in real time or with a delay); a pause / play button 806; an indicator 810 for the time remaining in the current cycle; an indicator 812 including comments; an indicator 814 for the name of the current cycle; a transfer indicator 816 indicating that the training cycle or training session includes a transfer cycle that presents the trainee with an auditory / visual interface, e.g., a dynamic auditory / visual interface, without providing feedback to the trainee; an autoplay indicator indicating that training progresses from cycle to cycle; an indicator 820 for the duration of neurofeedback blocks in all cycles of the current training; an indicator 822 for the number of active NF cycles in the current training session; and an indicator 824 for the total time set for the training cycle.

[0413] Here, we refer to Figure 8B, which shows an expert NF cycle interface according to some exemplary embodiments of the present invention.

[0414] According to some exemplary embodiments, the NF cycle interface 828 optionally includes an index 830 that describes the change in the calculated EFP signal or EEG signal during the NF cycle relative to a calculated baseline, for example, a local baseline. Optionally, the EFP signal index 830 is displayed next to the baseline index 832, for example, in a graph format, optionally in a continuous graph format.

[0415] According to some exemplary embodiments, the NF cycle interface 828 further includes a cycle control panel 834 indicator that optionally displays information about the current training (e.g., the number of cycles in the current training) and tools for controlling it; a current block indicator 836 that expands the current cycle and displays the name of its block, displaying the name of the current block in bold (optionally changing its background color to red (from reddish-gray) as the block progresses); a future cycle indicator 838 that optionally displays the number of future cycles; an additional cycle button 840 that allows adding cycles after the default cycle of the protocol (allowing experts to add cycles at any time after the start of the global baseline and before the end of the currently defined last cycle); a cycle clock indicator 842; and at least one of a pause / resume button 844.

[0416] Here, we refer to Figure 8C, which shows an expert NF cycle reporting interface according to some exemplary embodiments of the present invention.

[0417] According to some exemplary embodiments, the NF cycle reporting interface, e.g., interface 850, includes a graphical representation, such as a graph, of the changes in the calculated EFP signal during the local baseline session 852 and the NF training cycle 854. In some embodiments, the graphical representation is displayed relative to the graphical representation of the baseline or reference value, e.g., the local baseline 853. In some embodiments, the NF cycle reporting interface 850 is displayed to the expert during the rest block of the NF cycle, e.g., the rest block 628 shown in Figure 6B. Optionally, the NF cycle reporting interface includes at least one metric of the calculated progress score.

[0418] According to some exemplary embodiments, the calculated progress score indicates the subject's progress during the NF cycle, for example, in their ability to modulate the activity of at least one brain region or at least one brain network, based on changes in EFP (or EEG) signals during the NF cycle. In some embodiments, the NF system makes suggestions regarding the progression of NF therapy sessions and / or the overall NF therapy based on the calculated progress score.

[0419] According to some exemplary embodiments, the progress score is calculated based on a measure of the central trend of the calculated EFP signal when the calculated EFP signal reaches a desired value or when the calculated EFP signal is within a desired range. Alternatively or additionally, the progress score is calculated based on the time the calculated EFP signal is above or below a predetermined value, and / or the time the EFP signal is within a desired range during the NF cycle. Optionally, for example, the NF cycle progress score is displayed on interface 850.

[0420] Here, we refer to Figure 8D, which shows an NF session reporting interface according to some exemplary embodiments of the present invention.

[0421] According to some exemplary embodiments, an NF session reporting interface, e.g., interface 856, includes an index 858 for each NF cycle performed by the subject during an NF treatment session, and optionally, a graphical representation of each NF cycle performed during the NF treatment session. Interface 856 also includes an index 860 for the change in progress score calculated for each NF cycle during an NF treatment session. In some embodiments, the NF system modifies at least one parameter of the NF treatment session based on the change in progress score. For example, if the change in progress score, or a measure of the central trend of the progress score, is insufficient, the NF system precedes the next NF treatment session. Alternatively or additionally, the NF system modifies, for example, an interface (e.g., an auditory / visual interface) displayed to the subject during at least one NF cycle, based on the change in progress score 860. In some embodiments, the NF system makes suggestions for modifying at least one parameter of the NF session based on the change in progress score and / or a measure of the central trend of the progress score. In some embodiments, the progress score is calculated by standardizing the mean EFP difference between the NF cycle and the local baseline median EFP using the interquartile range or other statistical grouping of the local baseline.

[0422] Here, we refer to Figure 8E, which shows a summary interface for NF treatment in a subject, for example, a trainee, according to some exemplary embodiments of the present invention.

[0423] According to several exemplary embodiments, a trainee NF treatment summary interface, e.g., interface 856, comprises a summary of all NF treatment sessions performed on a subject, e.g., a trainee. Interface 856 optionally includes an index relating to at least one scheduled NF treatment session. In some embodiments, for each NF treatment session, interface 856 includes at least one of the following: an index 858 relating to the NF protocol used in the NF treatment session; an index 860 relating to the date of the NF treatment session; an index 862 relating to the change in progress score of the NF cycle performed in the NF session, e.g., in the form of a graphical representation; an index 864 representing the central trend of the progress score for each NF session; and an index 866 relating to an evaluation questionnaire administered by the subject and optionally to the scores of the questionnaire. Interface 856 optionally includes a reminder index 868 prompting, e.g., to perform a specific evaluation questionnaire.

[0424] According to some exemplary embodiments, the questionnaire is completed using the NF system's user interface, for example, as shown in Figure 8F. Optionally, the NF system calculates an evaluation questionnaire score based on the answers entered in the electronic form of the questionnaire. In some embodiments, the questionnaire calculation score is displayed in 866.

[0425] According to some exemplary embodiments, the NF system calculates a subject status score based on calculated questionnaire scores, or scores from different questionnaires, or scores from the same questionnaire over time. In some embodiments, as shown, for example, in Figure 8G, the memory of the NF system includes electronic forms of one or more assessment questionnaires (e.g., electronic form of the DSM-5 Applied PTSD Checklist (PCL-5), electronic form of the Patient Health Questionnaire-9, DSM-5 Applied PTSD Clinical Diagnostic Interview Scale (CAPS-5) and / or parameters or domains of CAPS-5, and Patient Health Questionnaire-9 (PHQ-9). Alternatively or additionally, the Hamilton Depression Rating Scale or any derivative, Snays-Hamilton This includes the Ton Pleasure Scale (SHAPS) or any derivative, the Montgomery-Asberg Depression Rating Scale (MADRS) or any derivative, the Patient Health Questionnaire (PHQ) or any derivative, and the Clinical Global Impression Scale (CGI) or any derivative. Alternatively or additionally, if the number of items is small, it may include the Adult Attention-Deficit / Hyperactivity Disorder (ADHD) Investigator's Symptom Rating Scale (AISRS) or a derivative thereof, the Adult ADHD Self-Report Scale (ASRS) or a derivative thereof, the Attention Variable Test (TOVA), or the Patient Health Questionnaire (PHQ).

[0426] According to some exemplary embodiments, the memory of a subject's device, for example, a personal device 214, includes one or more forms of electronic evaluation tests.

[0427] According to some exemplary embodiments, a software application in the memory of the NF system and / or personal device allows completion of electronic forms, automatically calculates scores for assessment tests, and / or provides recommendations to the subject and / or professional based on the calculated assessment test scores.

[0428] Exemplary relationship between the patient's condition and the progress of NF treatment. According to some exemplary embodiments, for example, as described in blocks 106, 450, 456, 483, 484, 502, and 512, the subject's condition, e.g., clinical, mental, and / or cognitive state, is determined during NF therapy, for example, during at least one NF therapy session. The subject's progress during at least one NF therapy session is also determined, for example, as described in 862 and 864. In some embodiments, the NF system determines and calculates, for example, the relationship between the determined subject's progress and the determined subject's condition.

[0429] In some embodiments, the NF system provides experts with at least one indicator for the determined relationships, and optionally also provides an indicator for trainees. In some embodiments, the determined relationships are used by the system or healthcare professionals (HCPs) to assess the current success of NF treatment or to predict the future success of NF treatment. Optionally, at least one parameter of NF treatment or NF treatment sessions is modified based on the determined relationships.

[0430] Here, we refer to Figure 9A, which shows a method for determining the relationship between the progress of NF treatment and the condition of a subject according to some exemplary embodiments of the present invention.

[0431] According to several exemplary embodiments, in block 902, information regarding the subject's progress in NF treatment is received. In some embodiments, the information includes, for example, a score indicating the subject's progress in modifying the activity or biomarkers of at least one brain region and / or at least one brain network in at least one cycle of active NF, e.g., cycle 626 of the NF treatment session. In some embodiments, the score is score 864, as shown in Figure 8E. In some embodiments, the progress score is calculated by standardizing the mean EFP difference between the NF cycle and the local baseline median EFP by the interquartile range (IQR) or other statistical grouping of the local baseline. In some embodiments, the progress score is a measure of the central trend of the difference between the EFP signal measured during the active NF cycle and the baseline median, or any other measure of the central trend of the baseline or EFP signal measured at, for example, the global baseline or local baseline. In some embodiments, the progress score is a value indicating the subject's ability to modify at least one brain region and / or at least one brain network or its biomarkers when applying a particular strategy and / or engaging with a particular auditory and / or visual interface, e.g., interface 604. Optionally, the score is based on measured changes in EEG or EFP signals during the NF cycle.

[0432] According to some exemplary embodiments, information regarding the patient's condition is received in block 902. In some embodiments, the information is based on the determination of the subject's condition, as described, for example, in blocks 106, 450, 456, 483, 484, 502, and 512 of Figures 1, 4B, 4C, and 5.

[0433] According to some exemplary embodiments, in block 908, trends indicating changes in the subject's state and trends indicating changes in the subject's progress are generated separately. In some embodiments, the generated trends are displayed, for example, to the supervisor of the NF therapy. In some embodiments, the trends or trend relationships are used to determine the subject's mental or cognitive state and optionally to plan or determine an NF cycle, NF session, the entire NF therapy, or at least one subsequent step of a different therapy, such as psychotherapy and / or pharmacotherapy, in the subject.

[0434] According to some exemplary embodiments, block 910 optionally generates predictive trends of the subject's condition and progress. In some embodiments, the predicted trends describe future changes in the subject's condition and progress, for example, after at least one NF treatment session and / or at least one week later, or at least one month later.

[0435] Furthermore, if a predicted trend is generated, in some embodiments, the generated predicted trend is optionally displayed to the expert.

[0436] According to some exemplary embodiments, in block 912, the NF system optionally proposes one or more modifications to the NF treatment based on the generated trend and / or the predicted trend. In some embodiments, if the progress trend is mild progress and the state trend indicates that the state is lower / higher than the desired state, the NF system instructs to continue with the current NF treatment setting and update the state after at least one NF treatment. Alternatively or additionally, if the progress trend is mild progress and the state trend indicates that the subject's state is lower and / or higher than the desired state, the NF system instructs to perform a state assessment of at least one subject after a certain time interval following the NF treatment session and / or at the start of the next NF treatment session.

[0437] According to some exemplary embodiments, if the progress trend indicates significant progress and the status trend indicates that the subject's status is higher and / or lower than the desired status, the NF system provides instructions to continue the current treatment setting, delay the next NF treatment session, or modify at least one parameter of the next NF treatment session, such as increasing the difficulty of the NF treatment session and / or shortening the duration of the NF treatment session and / or changing the prescription of the standard of case (SOC) modality.

[0438] According to some exemplary embodiments, if the progress trend indicates a subject's progress is very slow and the status trend indicates the subject's status is lower than the desired status, the NF system provides at least one of the following instructions: instructions to shorten the time until the next NF treatment session; instructions to use a different auditory / visual interface; instructions to instruct the subject to use a different strategy when using an auditory / visual interface; instructions to discontinue NF treatment, for example, instructions to discontinue or initiate another treatment such as pharmacotherapy; instructions to modify another treatment being administered to the subject (for example, modifying the drug administration schedule for pharmacotherapy); instructions to modify the intensity of treatment in terms of time between sessions or drug dosage, for example, modifying the drug administration schedule for pharmacotherapy; or instructions to modify the length of treatment sections, such as global baseline, local baseline, and NF sections.

[0439] According to some exemplary embodiments, in block 914, the NF system automatically modifies NF therapy based on generated and / or predicted trends. In some embodiments, the NF system automatically modifies at least one parameter of an NF therapy session, for example, shortening or lengthening the interval between NF therapy sessions, rescheduling subject evaluation sessions, rescheduling NF therapy sessions, modifying or replacing auditory / visual interfaces, and / or modifying the number and / or duration of active NF cycles.

[0440] In some exemplary embodiments, in block 915, the relationship between treatment progress and patient status is determined. In some embodiments, determining the relationship includes, for example, calculating a composite score, such as a patient status score, based on the treatment progress score and the patient status. In some embodiments, the composite score is calculated by weighting the calculated patient status score and the treatment progress score, respectively. In some embodiments, the composite score is a score indicating the degree of matching between the NF treatment and a particular subject. In some embodiments, the composite score is a score indicating whether an NF treatment with specific parameter values ​​is suitable for a particular subject.

[0441] According to some exemplary embodiments, a predictive score is optionally generated in block 918. In some embodiments, the predictive score indicates the degree of matching with a particular subject in the future to an NF treatment, for example, when modifying one or more parameters of the NF treatment, or to better personalize the NF treatment for a particular subject.

[0442] According to some exemplary embodiments, the NF system, for example, makes a proposal in block 912 for a method of individualizing NF treatment for a particular subject based on a predicted score generated in block 918 and / or a score calculated in block 915.

[0443] According to some exemplary embodiments, in block 914, the NF system automatically modifies the treatment to better individualize the NF treatment for a particular subject. In some embodiments, in block 914, the NF system automatically modifies at least one parameter of the NF treatment.

[0444] Herein, we refer to Figure 9B, which shows a graphical interface illustrating the relationship between changes in the score of at least one evaluation questionnaire representing the subject's condition and changes in the progress score at different points in time during NF treatment, according to some exemplary embodiments of the present invention.

[0445] According to some exemplary embodiments, the NF system is configured to display, for example, the relationship between the subject's status or indicators and the progress score or indicators in a graphical interface, optionally as trend lines in at least one graph. In some embodiments, the subject's status interface, e.g., interface 930, includes a graph showing changes in scores 940 of at least one assessment questionnaire between different NF treatment sessions 946 in the form of trend lines, e.g., a line 942 showing changes in the PCL-5 score and a line 944 showing changes in the PHQ-9 score. Interface 930 also displays changes in the progress score 948 measured at the end of each NF treatment session. In some embodiments, interface 930 displays predicted scores, e.g., predicted PCL-5 score 950, predicted PHQ-9 score 952, predicted progress score 954, and the subject's predicted mental and / or predicted cognitive state for at least one planned NF treatment session, e.g., session 956.

[0446] According to some exemplary embodiments, the NF system makes suggestions to the professional based on the relationship between changes in evaluation questionnaire scores and changes in progress scores in already completed NF treatment sessions, and optionally also makes suggestions based on predicted relationships, for example, based on predicted progress scores and predicted evaluation questionnaire scores.

[0447] Herein, we refer to Figure 9C, which shows a graphical interface illustrating an overview of a subject's progress during NF treatment and changes in one or more mental state tests during NF treatment, according to some exemplary embodiments of the present invention.

[0448] According to some exemplary embodiments, the system, for example, system 302 shown in Figure 3A, generates indicators for the supervisor of the NF treatment, based on information about the progress of the subject receiving NF treatment, e.g., a patient or trainee, in the NF treatment, and information about the subject's mental state during the NF treatment, e.g., cognitive state. In some embodiments, the indicators include a visual interface (optionally, e.g., a graphical interface 960). In some embodiments, the indicators include information about changes in a score calculated by system 302 indicating that the subject has successfully corrected the feedback signal in a desired direction, and / or information about the subject's ability to correct the activity of at least a portion of their brain, e.g., at least one brain region, at least one brain network, and / or a system of at least one brain. In some embodiments, the indicators include information about changes in the feedback signal during the NF treatment, and / or changes in brain activity.

[0449] According to some exemplary embodiments, the graphical interface 960 provides a visual indicator, optionally in the form of a graph 962, showing the change in the progress score of NF treatment during NF treatment, including several treatment sessions 970. In some embodiments, the graph 962 is based on the progress score calculated by the system before and after each treatment session. In some embodiments, the progress score is an objective score that is optionally automatically calculated by the system 302.

[0450] Furthermore, the graphical interface optionally provides visual indicators of changes in the subject's mental state as measured by one or more mental state tests, such as questionnaires, in the form of, for example, graphs 964, 966, and 968. In some embodiments, graphs 964, 966, and 968 show changes in CAPS-5, PCL-5, and PHQ-9 during NF treatment, respectively, and are optionally displayed in the same graphical interface alongside a graph 962 showing changes in the progress score of NF treatment.

[0451] By presenting both an objective score indicating the progress of the subject's NF treatment and an indicator showing changes in the subject's mental state, the NF therapist may be able to monitor the effectiveness of the NF treatment on the subject's mental state during and at the end of the treatment, for example, based on the correlation between the progress of the NF treatment and changes in the subject's mental state. In some embodiments, monitoring may allow the supervisor to modify the NF treatment, or the entire treatment provided to the subject, if there is no correlation and / or no change in the subject's mental state. Alternatively, monitoring may allow the supervisor to discontinue the NF treatment or combine it with at least one additional treatment, such as pharmacotherapy, CBT therapy, behavioral therapy, psychotherapy, a different NF treatment or biofeedback therapy, or other treatment, in order to improve the subject's mental state.

[0452] By presenting both objective scores indicating the progress of the subject's NF treatment and indicators showing changes in the subject's mental state, clinicians treating the subject, and / or health maintenance organizations (HMOs), and / or insurance companies may have the additional advantage of being able to monitor the subject's mental state and / or the impact of NF treatment on the subject's mental state using a single interface, and optionally discontinue NF treatment, modify NF treatment, and / or modify the entire treatment provided to the subject.

[0453] As used herein, "approximately" means "within ±20%" with respect to quantity or value.

[0454] The terms "comprises," "comprising," "includes," "including," and "having," along with their conjugations, all mean "including but not limited to."

[0455] The term "consisting of" means "including and limited to."

[0456] The phrase "consisting essentially of" means that the composition, method, or structure may include additional components, steps, and / or parts, provided that these additional components, steps, and / or parts do not substantially alter the basic and novel properties of the composition, method, or structure described in the claim.

[0457] In this specification, the singular pronouns "a," "an," and "the" also refer to plural nouns unless the context clearly indicates otherwise. For example, "a compound" or "at least one compound" may include multiple compounds, and may also include mixtures thereof.

[0458] Throughout this application, various embodiments of the invention may be presented in range form. It should be understood that the use of range form is merely for convenience and brevity, and not as a limitation that restricts the flexibility of the scope of the invention. Therefore, a range description should be considered to specifically disclose all possible sub-ranges and the individual numerical values ​​within those ranges. For example, a range description such as 1-6 specifically discloses not only sub-ranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, but also the individual numerical values ​​within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the size of the range.

[0459] Where a numerical range is indicated herein (for example, “10-15”, “10 to 15”, or any set of numbers linked by other ways of indicating a range), it is intended to include any number (fraction or integer) within the limits of the indicated range, unless otherwise clearly indicated by context. The expressions “range between” an indicated first number and an indicated second number, and “range from” an indicated first number to an indicated second number, “range up to,” “range to,” or “range including” (or other similar range-indicating terms) are used interchangeably herein and mean to include the indicated first and second numbers, as well as all fractions and integers between them.

[0460] Unless otherwise indicated, the numbers used herein and any range of numbers derived therefrom are approximations within reasonable measurement and rounding tolerances, as will be understood by those skilled in the art.

[0461] As used herein, the term “method” means a form, means, technique, and procedure for achieving a given task, and includes, but is not limited to, those known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine, or those readily available to practitioners from known forms, means, techniques, and procedures.

[0462] As used herein, the term “treat” includes stopping, substantially inhibiting, delaying, or reversing the progression of a condition, substantially relieving the clinical or aesthetic symptoms of a condition, or substantially preventing the worsening of the clinical or aesthetic symptoms of a condition.

[0463] It should be understood that certain features of the present invention described in relation to separate embodiments for clarity may also be provided in combination in one embodiment. Conversely, several features of the present invention described in relation to one embodiment for brevity may also be provided separately, in any preferred partial combination, or in any other appropriate described embodiment. Certain features described in relation to various embodiments should not be considered essential requirements of an embodiment unless the particular embodiment is inoperable without that element.

[0464] Although the present invention has been described in relation to its specific embodiments, numerous alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, all such alternatives, modifications, and variations are intended to be included within the spirit and broader scope of the appended claims.

[0465] The applicant intends that all publications, patents, and patent applications referenced herein be incorporated herein by reference in whole to the same extent that each individual publication, patent, and patent application is incorporated herein by specific and individual reference. In addition, no citation or specification of any reference in this application should be construed as an acceptance that such reference can be used as prior art of the present invention. Nor should the titles of each section be construed as limitations to the extent in which they are used. Furthermore, if there are any priority documents for this application, they should be incorporated herein by reference in whole.

Claims

1. A method for administering a neurofeedback (NF) process to a subject, The treatment involves educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least one NF session of treatment, and the performance of such treatment is To present sensory indicators to the aforementioned subjects, Instructing the subject to modify the sensory indicators by performing a specific activity, During the presentation, monitor changes in the activity of the at least one brain region or the at least one brain network, and During the presentation, provide the subject with a feedback signal indicating the monitored change. This includes educating, After the completion of the aforementioned NF session, a maintenance session of the aforementioned NF process is performed for the subject, wherein the maintenance session is: Presenting to the subject a trigger selected to evoke the sensory indicator used during the NF process session, and In response to the aforementioned presentation, instruct the subject to perform the specific activity used during the NF process session, This includes implementing, Methods that include...

2. The aforementioned education is conducted at the treatment center, and the aforementioned implementation is conducted outside the treatment center, and the treatment center includes clinics. The method according to claim 1.

3. The education includes measuring electrical signals from the subject's brain during the education, and the monitoring includes monitoring the changes in the activity of the at least one brain region or the at least one brain network based on the measured electrical signals. The method according to claim 1 or 2.

4. Performing the aforementioned maintenance session does not involve measuring electrical signals from the subject's brain. The method according to claim 3.

5. The aforementioned electrical signals include electroencephalogram (EEG) signals. The method according to claim 3 or 4.

6. The educating includes educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least two NF sessions of the NF process with at least a 24-hour interval between them, and the implementing includes implementing the maintenance session on the subject during the interval. The method according to any one of claims 1 to 5.

7. This includes receiving input from the subject after the education, The aforementioned actions are performed in response to the received input. The method according to any one of claims 1 to 5.

8. The input includes information relating to at least one of the cognitive, behavioral, and / or mental difficulties that the subject is currently experiencing or is expected to experience. The method according to claim 7.

9. This includes diagnosing the subject having a mental disorder or brain disorder prior to the education, and / or identifying that the subject exhibits at least one symptom of the mental disorder or brain disorder prior to the education. The method according to any one of claims 1 to 8.

10. The aforementioned mental or brain disorders include stress disorders, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorders (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The method according to claim 9.

11. This includes adjusting the timing of the education and / or the implementation of the education, depending on the severity of the mental disorder or the severity of at least one symptom. The method according to claim 10.

12. The trigger is at least partially similar to the sensory index presented to the subject during the NF session. The method according to any one of claims 1 to 11.

13. The aforementioned at least one specific brain region includes the amygdala and / or ventral striatum. The method according to any one of claims 1 to 12.

14. The aforementioned at least one specific brain network includes a limbic system network and / or a reward network. The method according to any one of claims 1 to 13.

15. A method for administering a neurofeedback (NF) process to a subject, The method involves educating the subject to modify the activity of at least one specific brain region or at least one specific brain network by performing at least one NF session of the NF process, wherein the performance is To present sensory indicators to the aforementioned subjects, Instructing the subject to modify the sensory indicators by performing a specific activity, During the presentation, monitor changes in the activity of the at least one brain region or the at least one brain network, and During the presentation, provide the subject with a feedback signal indicating the monitored change. This includes educating, Determining the subject's state after completing at least one NF session, wherein the subject's state includes at least one of the subject's mental state, behavioral state, and / or cognitive state. Methods that include...

16. This includes receiving information about the subject's status after completing at least one NF session, The aforementioned information includes the results of at least one assessment questionnaire, self-reported information, and / or expert input regarding the subject's condition. The method according to claim 15.

17. The aforementioned at least one assessment questionnaire may be the PTSD Clinical Diagnostic Interview Scale (CAPS-5) and / or parameters or domains of the CAPS-5 or a derivative of the CAPS-5, the PTSD Checklist (PCL-5) or a derivative of the DSM-5, the Patient Health Questionnaire-9 (PHQ-9) or a derivative of the PHQ-9, the Hamilton Depression Rating Scale or a derivative of the Hamilton Depression Rating Scale, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative of the SHAPS, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative of the PHQ-9, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical Global Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Disorder (ADHD) Investigator's Symptom Rating Scale (AIRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variables Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Brief Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The method according to claim 16.

18. If the determined state of the subject is worse than the target state, the process includes scheduling at least one additional NF session to repeat the education. The method according to any one of claims 15 to 17.

19. If the determined condition of the subject is worse than the target condition, the method includes modifying at least one of the sensory indicators, the specific activity, the instructions provided to the subject during the education, and / or the specific activity applied by the subject, in accordance with the determined condition. The method according to any one of claims 15 to 18.

20. This includes performing or scheduling maintenance sessions for NF treatment according to the determined state, The maintenance session includes presenting the subject with indicators configured to evoke the sensory indicators used during the education, and instructing the subject to perform the specific activity used during the education. The method according to any one of claims 15 to 19.

21. This includes sending a suggestion to the person or a specialist who monitors the treatment, depending on the condition of the person determined above. The aforementioned proposal includes a proposal to initiate, discontinue, or modify at least one additional treatment, wherein the at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and behavioral therapy. The method according to any one of claims 15 to 20.

22. Prior to the education, the subject is diagnosed with a mental disorder or at least one symptom of the mental disorder, The aforementioned mental disorders include at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The method according to any one of claims 15 to 21.

23. A method of administering neurofeedback (NF) therapy to a subject, Administering the NF therapy to educate the subject to modulate the activity of at least one specific brain region, wherein the administration includes administering two or more sessions of the NF therapy with at least one day interval between them. During the administration of the NF treatment, progress indicators are generated relating to the progress of the subject's ability to regulate the activity of at least one specific brain region, and subject status indicators relating to the subject's mental and / or behavioral state. Displaying the aforementioned progress indicator and the aforementioned subject status indicator on a shared visual interface, Methods that include...

24. The aforementioned progress indicators and the aforementioned subject status indicators are displayed side by side in the shared visual interface. The method according to claim 23.

25. This includes modifying the NF treatment administered to the subject based on the generated progress indicators and / or subject status indicators. The method according to claim 23 or 24.

26. To determine the correlation between the aforementioned progress indicator and the aforementioned subject status indicator, This includes modifying the NF treatment administered to the subject based on the determined correlation, The method according to any one of claims 23 to 25.

27. Generating the progress indicators includes calculating a progress score indicating the progress of the subject and at least one subject status score indicating the status of the subject, and displaying includes displaying the progress score and the at least one subject status score on the shared visual interface. The method according to any one of claims 23 to 26.

28. The display includes displaying the changes in the progress score and the changes in the subject status score on the shared visual interface. The method according to claim 27.

29. The subject's condition includes at least one of the subject's mental state, cognitive state, and functional state. The method according to any one of claims 23 to 28.

30. This includes receiving information regarding the status of the subject, The subject status index is generated based on the received information. The method according to any one of claims 23 to 29.

31. The received information includes the results of at least one evaluation questionnaire, input received from the subject, and / or input received from the expert. The method according to claim 30.

32. The above generation includes generating a predicted progress indicator and a predicted subject status indicator, and the above display includes displaying the trend of the predicted progress indicator and the predicted subject status indicator. The method according to any one of claims 23 to 31.

33. A method for determining whether an electrode has a target signal quality, Recording electrical signals using at least two electrodes attached to the subject's body, The recorded electrical signals, Identifying at least one of the two electrodes that generates an electrical signal with a target peak-to-peak value, Setting a target range for the identified peak-to-peak values, and If the signal recorded by at least one additional electrode among the at least two electrodes has a peak-to-peak value within the target range of the set value, and the amplitude of the signal is within a predetermined range or higher than a predetermined amplitude value, then it is determined that the signal has the target signal quality. To process by, Based on the aforementioned determination, the objective is to provide an indicator that can be detected by a human, Methods that include...

34. The recording, processing, determination, and provision are performed before and / or during biofeedback therapy. The method according to claim 33.

35. An NF system for administering NF therapy to a subject, comprising at least one neurofeedback (NF) therapy session and at least one maintenance session, (a) An NF device configured to administer the subject at least one NF therapy session, wherein the subject is provided with the at least one sensory index along with instructions to adjust the at least one sensory index by performing at least one specific activity during the at least one NF therapy session, (b) A personal device of the subject configured to communicate with the NF device and to administer at least one maintenance session of the NF therapy, wherein the at least one maintenance session is configured to trigger at least a portion of the at least one NF therapy session in the subject, Equipped with, The aforementioned personal device is A memory storing a maintenance protocol which includes at least one trigger configured to evoke the sensory indicators provided by the NF device during the at least one NF treatment session, User interface and A control circuit is provided, wherein the control circuit is configured to provide, using the user interface, the at least one trigger and an instruction to perform the at least one specific activity used during the at least one NF treatment session. NF System.

36. The sensory indicator includes a visual interface and / or an auditory interface, and the trigger is at least partially similar to the visual interface and / or auditory interface. The system according to claim 35.

37. The memory of the personal device includes a timing schedule for executing the at least one maintenance session, and the control circuit of the personal device is configured to execute the at least one maintenance session according to the timing schedule. The system according to claim 35 or 36.

38. The aforementioned NF device is A memory storing at least one NF treatment protocol including at least one sensory index and instructions provided to the subject by the NF device, User interface and The control circuit comprises, and the control circuit is To provide the subject with at least one sensory indicator using the user interface, The subject is instructed to adjust the provided at least one sensory index by performing at least one activity. During the provision of the at least one sensory index, electrical signals are received from one or more electrodes attached to the subject's body. Using the aforementioned electrical signals, measure an indicator of the activity of at least one specific brain region or at least one specific brain network, or an indicator of changes in such activity. By continuously or intermittently modifying the at least one sensory index according to the measured index, a feedback signal indicating the activity of the at least one brain region or the at least one brain network, or a change in such activity, is provided to the subject. It is configured to perform The system according to any one of claims 35 to 37.

39. The control circuit is configured to measure an electroencephalogram (EEG) signal based on the received electrical signal, and the EEG signal indicates the activity or change in the activity of at least one specific brain region or at least one specific brain network. The system according to claim 38.

40. The aforementioned at least one specific brain region includes at least one subcortical brain region, optionally the at least one subcortical brain region includes the amygdala, ventral striatum, subcortical brain region of the limbic system, and / or subcortical brain region of the reward system. The system according to claim 39.

41. The memory of the personal device and / or the memory of the NF device stores information about the subject's mental state, and the control circuit of the personal device determines whether to initiate the at least one maintenance session or to determine a timing schedule for initiating the at least one maintenance session based on the information about the mental state. The system according to any one of claims 38 to 40.

42. The control circuit of the personal device is configured to modify the at least one NF maintenance session in accordance with the information relating to the mental state of the subject. The system according to claim 41.

43. The aforementioned information includes information regarding whether the subject has been diagnosed with a mental disorder or brain disorder, or whether he / she is exhibiting symptoms of a mental disorder or brain disorder. The system according to claim 41 or 42.

44. The aforementioned mental or brain disorder includes at least one of the following: stress disorder, post-traumatic stress disorder (PTSD), depression, attention-deficit / hyperactivity disorder (ADHD), substance use disorder (SUD), dementia, Alzheimer's disease, mild cognitive impairment, and autism. The system according to claim 43.

45. The system includes a remote device that communicates with the aforementioned NF device and the aforementioned personal device, The remote device is A memory having subject-related information including information about the subject's mental state and / or information about the subject's daily activities, A communication circuit configured to communicate with the NF device and the personal device, and The device comprises a control circuit, which is configured to determine the schedule for at least one additional maintenance session and / or at least one additional NF therapy session according to the stored mental state information, and to signal the communication circuit to provide the schedule to the NF device and / or the personal device. The system according to any one of claims 41 to 44.

46. The control circuit of the remote device determines the schedule, which includes bringing forward the at least one additional maintenance session and / or the at least one additional NF treatment session if the subject-related information indicates that the subject is expected to have difficulty with the daily activities. The system according to claim 45.

47. The control circuit's determination of the schedule includes delaying the at least one additional maintenance session and / or the at least one additional NF treatment session if the subject-related information indicates a deterioration in the subject's mental state. The system according to claim 45 or 46.

48. The instructions provided to the subject by the personal device include instructions to apply at least one cognitive activity, which is indicated to modulate the provided at least one sensory index when applied by the subject during at least one NF therapy session. The system according to any one of claims 35 to 47.

49. An NF device for administering neurofeedback (NF) therapy to a subject to train the subject to modulate the activity of at least one specific brain region or at least one specific brain network, A memory storing at least one NF protocol, progress indicators indicating the progress of the subject's ability to modulate the activity of at least one specific brain region or at least one specific brain network, and mental state indicators having information about the subject's mental state during NF treatment, A supervisor interface that communicates with the aforementioned NF device, comprising a supervisor interface that generates and displays at least one visual interface, The NF device is configured to send signals to the supervisor interface to generate and provide the at least one visual interface having the progress indicator and the mental state indicator. system.

50. The at least one protocol stored in the memory includes at least one sensory indicator and instruction provided to the subject by the NF device, the NF device further comprises a user interface and a control circuit, the control circuit is To provide the subject with at least one sensory indicator using the user interface, Instructing the subject to adjust the provided at least one sensory index by performing at least one activity, Receiving electrical signals from one or more electrodes attached to the head of the subject, Using the aforementioned electrical signals, measure an indicator of the activity of at least one specific brain region or at least one specific brain network, or an indicator of changes in such activity. Providing a feedback signal to the subject during the provision of the at least one sensory index according to the measured index, It is configured to perform the following actions: The control circuit is further configured to generate the progress indicator based on the received electrical signal and to generate the mental state indicator based on the received information relating to the mental state of the subject. The system according to claim 49.

51. The control circuit is configured to receive an input signal having the information relating to the mental state of the subject, the input signal including the results of at least one evaluation questionnaire, self-reported information, and / or input from a professional or supervisor regarding the subject's condition. The system according to claim 50.

52. The aforementioned at least one assessment questionnaire may be the PTSD Clinical Diagnostic Interview Scale (CAPS-5) and / or parameters or domains of the CAPS-5 or a derivative of the CAPS-5, the PTSD Checklist (PCL-5) or a derivative of the DSM-5, the Patient Health Questionnaire-9 (PHQ-9) or a derivative of the PHQ-9, the Hamilton Depression Rating Scale or a derivative of the Hamilton Depression Rating Scale, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative of the SHAPS, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative of the PHQ-9, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical Global Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Disorder (ADHD) Investigator's Symptom Rating Scale (AIRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variables Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Brief Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The system according to claim 51.

53. The control circuit is configured to determine the correlation between the progress indicator and the subject's mental state indicator, and to send a signal to the supervisor interface to display the determined correlation. The system according to any one of claims 50 to 52.

54. The control circuit is configured to generate trends in the changes of the progress indicators and the changes in the subject's mental state indicators over a selected period of the NF treatment, and / or to predict them, and to send signals to the supervisor interface to display the generated trends in the changes of the progress indicators and the changes in the subject's mental state indicators, and / or to predict them. The system according to any one of claims 50 to 53.

55. The supervisor interface is configured to display the progress indicator and the mental state indicator side by side in at least one visual interface. The system according to any one of claims 49 to 54.

56. A system comprising an NF device for administering neurofeedback (NF) therapy to a subject to train the subject to modulate the activity of at least one specific brain region or at least one specific brain network, The aforementioned NF device is A memory storing mental state indices including at least one NF protocol and information about the mental state of the subject during NF treatment, A supervisor interface that communicates with the NF device, comprising a supervisor interface configured to generate and provide indicators detectable by at least one person, The NF device is configured to send signals to the supervisor interface to generate and provide the mental state index along with the index detectable by at least one person. system.

57. The NF device includes a control circuit, The control circuit is configured to receive an input signal having the information relating to the mental state of the subject, and to generate the mental state index based on the received input signal. The input signal includes the results of at least one assessment questionnaire, self-reported information, and / or input from a professional or supervisor regarding the mental state of the subject. The system according to claim 56.

58. The aforementioned at least one assessment questionnaire may be the PTSD Clinical Diagnostic Interview Scale (CAPS-5) and / or parameters or domains of the CAPS-5 or a derivative of the CAPS-5, the PTSD Checklist (PCL-5) or a derivative of the DSM-5, the Patient Health Questionnaire-9 (PHQ-9) or a derivative of the PHQ-9, the Hamilton Depression Rating Scale or a derivative of the Hamilton Depression Rating Scale, the Snays-Hamilton Pleasure Scale (SHAPS) or a derivative of the SHAPS, the Montgomery-Asberg Depression Rating Scale (MADRS) or a derivative of the PHQ-9, or the Patient Health Questionnaire. The Patient Health Questionnaire (PHQ) or its derivatives, the Clinical Global Impression Scale (CGI) or its derivatives, the Adult Attention-Deficit / Hyperactivity Disorder (ADHD) Investigator's Symptom Rating Scale (AIRS) or its derivatives, the Adult ADHD Self-Report Scale (ASRS) or its derivatives, the Attention Variables Test (TOVA) or its derivatives, the Patient Health Questionnaire (PHQ) or its derivatives, the Alzheimer's Disease Assessment Scale - Cognitive Sub-items (ADAS-Cog) or its derivatives, the Brief Mental State Examination (MMSE) or the Folstein Test or at least one of their derivatives, The system according to claim 57.

59. The perceptible indicators relating to the mental state of the subject include at least one of the following: a suggestion to reschedule at least one additional NF treatment session, a suggestion to discontinue the NF treatment, and / or a suggestion to modify at least one parameter of the NF treatment protocol. The system according to any one of claims 56 to 58.

60. The perceptible indicators relating to the mental state of the subject include at least one of the following: a proposal to combine the NF treatment with at least one additional treatment, or a proposal to modify the at least one additional treatment. The system according to any one of claims 56 to 59.

61. The aforementioned at least one additional treatment includes at least one of pharmacotherapy, psychotherapy, and / or behavioral therapy. The system according to claim 60.

62. A user interface that generates human-detectable metrics, A memory that stores a predetermined absolute range of signal amplitude values ​​or a threshold value for signal amplitude values, Control circuit and A biofeedback device comprising, The aforementioned control circuit is Receiving at least one first electrical signal recorded by at least one first electrode and at least one second electrical signal recorded by at least one second electrode, Processing the at least one first electrical signal and the at least one second electrical signal, Following the above process, it is determined that the at least one first electrical signal and the at least one second electrical signal are within the stored predetermined absolute range of peak-to-peak values. Based on the minimum peak-to-peak value of at least one first electrical signal, a relative threshold or relative minimum threshold peak-to-peak value is set. The determination that the at least one second electrical signal has the desired signal quality is made if the peak-to-peak average value of the at least one second electrical signal is within a relative threshold of the peak-to-peak value, or exceeds the relative minimum threshold peak-to-peak value. Based on the result of the determination, a signal is sent to the user interface to generate and provide a human-detectable index, along with information on whether or not the at least one second electrical signal has the desired signal quality. It is configured to perform Biofeedback device.

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