Methods and apparatus for transcutaneous nerve stimulation therapy

Abstract

A method for determining treatment parameter values of a transcutaneous neurostimulation therapy applied on a user's scalp comprises setting, for example according to a correlation comprising a direct relationship between at least one parameter value of a first set of treatment parameter values of a first electrode array engaged with a first portion of the user's scalp and a corresponding at least one parameter value of a set of user-specific sensory threshold parameter values, the first set of treatment parameter values for administering electrical pulses to the first portion, and setting, according to another correlation comprising another direct relationship between at least one parameter value of a second set of treatment parameter values of a second electrode array engaged with a second portion of the user's scalp and the at least one parameter value of the first set of treatment parameter values, the second set of treatment parameter values for administering electrical pulses to the second portion.

Description

[0001] Cross-reference of related applications

[0002] This patent application claims the benefit of U.S. Provisional Patent Application 62 / 888,497, filed August 18, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] This invention relates to devices and methods for applying electrical stimulation to the head region, and more specifically to methods for setting, calibrating, and verifying the reliability of electrical parameters for treatment using electrical nerve stimulation, and to devices and software applications that facilitate this calibration. Background of the Invention

[0005] This invention relates to devices and methods for applying electrical stimulation to a region of the head for neurostimulation therapy. The disclosed methods and apparatus can be used to calibrate therapeutic parameters used when stimulating peripheral and cranial nerves, including calibration by the user of the neurostimulation therapy.

[0006] Stimulation of peripheral and cranial nerves in the head region can treat a variety of conditions, such as chronic pain, migraines, tension headaches, cluster headaches, trigeminal neuralgia, occipital neuralgia, fibromyalgia, depression, post-traumatic stress disorder (PTSD), anxiety, tension, bipolar disorder, schizophrenia, obsessive-compulsive disorder (OCD), insomnia, epilepsy, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, obesity, multiple sclerosis, stroke, and traumatic brain injury (TBI). The anatomical structures of peripheral and cranial nerves in the head region (e.g., the anatomy of the occipital and trigeminal nerves) and their bulges leading to brainstem areas (e.g., the locus coeruleus and raphe nuclei) and higher brain regions (e.g., the thalamus and anterior cingulate cortex) can be advantageous when stimulating these nerves to treat such conditions.

[0007] Nerve stimulation of cutaneous nerves in the scalp (e.g., occipital nerve, supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve branches, and auriculotemporal nerve branches) can be applied invasively or non-invasively. Because transmitting current through hair is challenging, stimulation of cephal nerves beneath hair cover (e.g., the occipital nerve (more, less, and the third occipital branch)) is typically performed using implantable or percutaneous nerve stimulators. These devices include electrodes inserted under the scalp, thus bypassing the high-impedance barrier formed by hair and scalp. However, implantable nerve stimulation is an invasive and costly procedure with a high incidence of complications, including infection, bleeding, or subcutaneous fluid accumulation, and hardware-related failures (e.g., implant lead migration and breakage, and pulse generator failure). Percutaneous stimulation of cephal nerves (e.g., occipital nerve branches) using non-invasive techniques can achieve clinical results similar to those of implantable stimulators, but without the risks and costs associated with invasive surgery.

[0008] Transcutaneous nerve stimulation (TENS) therapy can be performed on the recipient in a comfortable personal environment. However, it should be noted that even percutaneous therapy may require user-specific and personalized settings for some treatment parameters (e.g., current intensity and pulse duration) encountered during treatment. Furthermore, directing electrical stimulation at different sites on the user's head may require differentiated treatment parameters to effectively stimulate the different nerves involved. Treatment parameters should be optimally set and calibrated to take into account both therapeutic efficacy and the comfort of the user receiving the treatment.

[0009] Therefore, devices and methods for effectively setting and calibrating neurostimulation therapy parameters that can be operated by both medical experts and treatment users are recognized as necessary and highly advantageous.

[0010] The following documents disclose systems, devices, and methods for performing neurostimulation therapy: applicant patents US 9,433,774 and US 9,872,979, and co-pending US patent application 15 / 510,067, filed September 16, 2015 and published as US 20170296121; applicant patent application 16 / 070,563, filed January 26, 2017 and published as US 20190022372; and applicant patent application 16 / 093,094, filed April 9, 2017 and published as US 20190117976; each of the foregoing patents and co-pending patent applications is incorporated herein by reference in its entirety. Invention Summary

[0011] According to an embodiment, a method is disclosed for determining user-specific treatment parameter values ​​for multichannel percutaneous nerve stimulation (PTS) applied at multiple locations on a user's scalp. The method includes: (a) setting a first set of treatment parameter values ​​for a first electrode array coupled to a first portion of the user's scalp according to a first correlation for applying electrical pulses to the first portion, the first correlation including a first direct relationship between at least one parameter value in the first set of treatment parameter values ​​and at least one corresponding parameter value in a set of user-specific sensory threshold parameter values; and (b) setting a second set of treatment parameter values ​​for a second electrode array coupled to a second portion of the user's scalp according to a second correlation for applying electrical pulses to the first portion, the second correlation including a second direct relationship between at least one parameter value in the second set of treatment parameter values ​​and the at least one parameter value in the first set of treatment parameter values.

[0012] In some implementations, each set of treatment parameter values ​​may include values ​​of at least two of the following: (i) a charge parameter having a value of total charge over a given time period, wherein the given time period is an integer multiple of the reciprocal of the electrical pulse frequency; (ii) a current intensity parameter; and (iii) a pulse duration parameter and a frequency parameter, or an arithmetic combination thereof.

[0013] In some implementations, (i) the first portion of the scalp is the front and the second portion of the scalp is the back, or (ii) the first portion of the scalp is the back and the second portion of the scalp is the front.

[0014] In some implementations, the second direct relationship may be based in part on the relationship between the respective electrode surface regions of the first electrode array and the second electrode array.

[0015] In some implementations, the values ​​of the set of user-specific sensory threshold parameters are based on a first user input received during the application of a series of electrical pulses to a single portion of the first and second portions of the user's scalp.

[0016] In some implementations, the first correlation and the second correlation are linear relationships based on corresponding empirical correlations.

[0017] In some implementations, based on the first direct relationship, the charge parameter value in the first set of treatment parameter values ​​can be equal to the charge parameter value in the set of user-specific sensory threshold parameter values ​​multiplied by A, where A is not less than 1.1 and not greater than 3.2. In some implementations, A can be not less than 1.4 and not greater than 2.0. In some implementations, A can be not less than 1.3 and not greater than 1.9.

[0018] In some implementations, based on the second direct relationship, the charge parameter value in the second set of treatment parameter values ​​can be equal to the charge parameter value in the first set of treatment parameter values ​​multiplied by B, where B is not less than 1.1 and not greater than 3.8. In some implementations, B can be not less than 1.4 and not greater than 3.4. In some implementations, B can be not less than 1.8 and not greater than 3.0.

[0019] In some implementations, the method may further include: calibrating treatment thresholds, wherein the calibration includes: (i) initiating a transcutaneous nerve stimulation calibration phase using the first set of treatment parameter values ​​and the second set of treatment parameter values ​​as corresponding treatment parameter values ​​applied to the first and second portions of the user's scalp; (ii) receiving user calibration input during the calibration phase; and (iii) changing at least one of the first set of treatment parameter values ​​and the second set of treatment parameter values ​​in response to receiving the user calibration input.

[0020] In some embodiments, the change of at least one value in the first set of treatment parameter values ​​and the second set of treatment parameter values ​​may include modifying at least one treatment parameter value, which is not current intensity.

[0021] In some embodiments, the changes can be constrained to keep the charge parameter values ​​within a predetermined range. In some embodiments, the changes can be constrained to limit the number of changes in each calibration phase to a predetermined number. In some embodiments, the changes can be constrained to a predetermined time interval. In some embodiments, the time between receiving the user calibration input and completing the change can be less than 1 second. In some embodiments, the time between receiving the user calibration input and completing the change can be less than 500 ms. In some embodiments, the time between receiving the user calibration input and completing the change can be less than 200 ms.

[0022] In some embodiments, the percutaneous nerve stimulation treatment may include anteriorly applied electrical pulses targeting the trigeminal nerve and posteriorly applied electrical pulses targeting the occipital nerve.

[0023] In some implementations, the application of the electrical pulse can be performed via a device including electrodes and mounted on the user's head, the device including headphones.

[0024] In some implementations, at least one of the first user input and the user calibration input may be received via a computer software program that runs on an external user operating device in electronic communication with the headset. In some such implementations, (i) the headset may include an on-ear user interface attached to the headset, and (b) at least one of the first user input and the user calibration input may be received via the on-ear user interface.

[0025] According to an embodiment, a method is disclosed for determining user-specific treatment parameter values ​​for multichannel percutaneous nerve stimulation (PTS) applied at multiple locations on a user's scalp. The method includes: (a) setting a first set of treatment parameter values ​​for a first electrode array coupled to a first portion of the user's scalp for applying electrical pulses to the first portion; and (b) setting a second set of treatment parameter values ​​for a second electrode array coupled to a second portion of the user's scalp according to a second correlation for applying electrical pulses to the second portion, the second correlation including a direct relationship between at least one parameter value in the second set of treatment parameter values ​​and at least one parameter value in the first set of treatment parameter values.

[0026] In some implementations, each set of treatment parameter values ​​may include values ​​of at least two of the following: (i) a charge parameter having a value of total charge over a given time period, wherein the given time period is an integer multiple of the reciprocal of the electrical pulse frequency; (ii) a current intensity parameter; and (iii) a pulse duration parameter and a frequency parameter, or an arithmetic combination thereof.

[0027] In some implementations, it is possible that (i) the first portion of the scalp is the front and the second portion of the scalp is the back, or (ii) the first portion of the scalp is the back and the second portion of the scalp is the front.

[0028] In some implementations, the direct relationship may be based in part on the relationship between the corresponding electrode surface regions of the first electrode array and the second electrode array.

[0029] In some implementations, the correlation may be based on a linear relationship of empirical correlation.

[0030] In some implementations, based on the direct relationship, the charge parameter value in the second set of treatment parameter values ​​can be equal to the charge parameter value in the first set of treatment parameter values ​​multiplied by B, where B is not less than 1.1 and not greater than 3.8. In some implementations, B can be not less than 1.4 and not greater than 3.4. In some implementations, B can be not less than 1.8 and not greater than 3.0.

[0031] In some embodiments, the percutaneous nerve stimulation treatment may include anteriorly applied electrical pulses targeting the trigeminal nerve and posteriorly applied electrical pulses targeting the occipital nerve.

[0032] In some implementations, the application of the electrical pulse can be performed via a device including electrodes and mounted on the user's head, the device including headphones.

[0033] According to the implementation scheme, a method is disclosed for determining user-specific treatment parameters for multichannel percutaneous nerve stimulation (PTS) applied at multiple locations on a user's scalp. The method includes: (a) providing the user's scalp with a first series of electrical pulses, the first series of electrical pulses having electrical parameter values ​​that increase at a first amplification rate, wherein the corresponding electrical parameter values ​​include at least one of a charge parameter value and a current intensity value; (b) in response to receiving a first user input indicating that the user has experienced dermal sensation related to the application of the first series of electrical pulses, defining a plurality of corresponding electrical parameter values ​​received from the first user input as a set of sensory threshold parameter values; and (c) providing the user's scalp with a reliability-confirming series of electrical pulses, the reliability-confirming series of electrical pulses having corresponding electrical parameter values ​​that increase at a second amplification rate, wherein the corresponding electrical parameter values ​​include charge... The provision of at least one of the parameter value and the current intensity value, wherein (i) the series of electrical pulses confirming the reliability is paused before the corresponding electrical parameter value reaches the sensory threshold parameter value, and (ii) the series of electrical pulses confirming the reliability is subsequently resumed after the pause; (d) in response to receiving a second user input indicating that the user has felt the application-related dermal sensation of the series of electrical pulses confirming the reliability of the sensory threshold parameter value at the corresponding electrical parameter value within a predetermined range of values ​​around the sensory threshold parameter value after the pause: confirming the reliability of the sensory threshold parameter value; and (e) applying the multichannel transcutaneous nerve stimulation treatment using a treatment parameter value based on the confirmed reliability of the sensory threshold parameter value.

[0034] In some implementations, the treatment parameter values ​​include values ​​of at least two of the following: (i) a charge parameter having a value of total charge over a given time period, wherein the given time period is an integer multiple of the reciprocal of the electrical pulse frequency; (ii) a current intensity parameter; and (iii) a pulse duration parameter and a frequency parameter, or an arithmetic combination thereof.

[0035] In some embodiments, the first series of electrical pulses may be applied to a first portion of the user's scalp, and the reliability-verifying series of electrical pulses may be applied to a second portion of the scalp, different from the first portion. In some embodiments, both the first series of electrical pulses and the reliability-verifying series of electrical pulses may be applied to the first portion of the user's scalp.

[0036] In some implementations, it is possible that (i) the first portion of the scalp is the front and the second portion of the scalp is the back, or (ii) the first portion of the scalp is the back and the second portion of the scalp is the front.

[0037] In some embodiments, the percutaneous nerve stimulation treatment may include anteriorly applied electrical pulses targeting the trigeminal nerve and posteriorly applied electrical pulses targeting the occipital nerve.

[0038] In some implementations, the provision of the first series of electrical pulses and the provision of the reliability confirmation series of electrical pulses can be performed by a device including electrodes and mounted on the user's head, the device including headphones.

[0039] In some implementations, at least one of the first user input and the second input may be received via a computer software program that runs on an external user operating device that is in electronic communication with the headset.

[0040] In some implementations, it is possible that (i) the headset includes an on-ear user interface attached to the headset, and (ii) at least one of the first user input and the second user input is received via the on-ear user interface.

[0041] According to an embodiment, a non-transitory computer-readable medium storing program instructions that, when executed by one or more processors, cause the one or more processors to perform any of the steps of any of the methods disclosed herein.

[0042] According to an embodiment, a user input device for use during percutaneous nerve stimulation therapy includes: a user interface; one or more processors; and a non-transitory computer-readable medium storing program instructions therein, which, when executed by one or more processors of the user input device, cause the one or more processors to perform any of the steps of any of the methods disclosed herein. In some embodiments, the user input device may be in electronic communication with a device including headphones and a plurality of electrodes configured to deliver electrical pulses to the user's scalp. Attached Figure Description

[0043] The invention is described herein by way of example only with reference to the accompanying drawings. Specific details are now referred to in the drawings, with emphasis placed on the fact that the details shown are for the purpose of illustrating preferred embodiments of the invention by way of example only, and are presented to provide what is considered most useful and readily understood descriptions of the principles and conceptual aspects of the invention. Therefore, no attempt is made to show the structural details of the invention in more detail than necessary for a thorough understanding of the invention; the description, taken in conjunction with the drawings, enables those skilled in the art to understand how the invention can actually be embodied in several forms. Throughout the drawings, the same numbered characters are used to indicate similar functions, but not necessarily the same elements.

[0044] In the diagram:

[0045] Figure 1 This is a schematic block diagram of an inventive system for nerve stimulation based on the implementation scheme taught in this article.

[0046] Figure 2 provides a schematic perspective illustration of an inventive wearable headset suitable for communication with a remote control unit, mobile phone, and computer.

[0047] Figure 3 It is in the form of headphones as taught in this article. Figure 1 A three-dimensional schematic diagram illustrating the implementation scheme of the inventive system of A.

[0048] Figures 4 to 13 A flowchart illustrating a method block according to an embodiment of the present invention is provided, the method block including method steps for defining, setting, testing, verifying, calibrating, and applying transcutaneous nerve stimulation parameters.

[0049] Figure 14 to Figure 19 A flowchart illustrating a method according to an embodiment of the present invention is shown, the method comprising: Figures 4 to 13 Various methods, steps, and method components. Detailed Implementation

[0050] This document describes systems and methods for applying electrical stimulation to a scalp to stimulate peripheral and / or cranial nerves, applying transcranial stimulation to brain regions, sensing bodily parameters, monitoring tissues, and adapting the electrical stimulation signals to user characteristics and over time. These systems and methods ensure effective electrical stimulation while avoiding damage to scalp tissue and user discomfort, and operate in a safe and robust manner.

[0051] The inventive method can be applied using a head-mounted structure that serves as a platform to apply electrical stimulation according to the inventive method to treat various conditions, such as migraine, tension headache, cluster headache, trigeminal neuralgia, occipital neuralgia, chronic pain, fibromyalgia, tension, depression, post-traumatic stress disorder (PTSD), anxiety, obsessive-compulsive disorder (OCD), insomnia, epilepsy, attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, obesity, multiple sclerosis, traumatic brain injury (TBI), and stroke.

[0052] As used in this article, the term 'user' refers to a person who receives or will receive transcutaneous stimulation therapy using electrical stimulation. Electrical stimulation of purely sensory nerves will evoke a radiation of sensory abnormalities along the nerve's distribution in response to the applied electrical stimulation.

[0053] This disclosure processes a 'skin sensation' experienced by a user in response to the application of transcutaneous electrical nerve stimulation, and the 'skin sensation' may include one or more of tingling, tingling, cold, burning or numbness; this skin sensation may be equivalent to a sensory abnormality.

[0054] The minimum threshold at which a user feels or acknowledges feeling this tactile or sensory abnormality is called the 'sensory threshold'; the sensory threshold can vary from user to user in a given situation and at a given time.

[0055] Now for reference Figure 1 , Figure 1 This is a schematic block diagram of an exemplary system for neural stimulation based on the embodiments taught herein.

[0056] As seen, the system 101 for neurostimulation may include at least two stimulating electrodes 102, and in some embodiments may also include at least two sensing electrodes 104, both of which are functionally associated with electronic circuitry 106. The stimulating electrodes 102 are adapted to engage with the skin of a user's scalp to deliver an electric current to the skin of the user's scalp, as described below. In some embodiments, one or more of the sensing electrodes 104 may be adapted to engage with the user's skin and may be configured to sense at least one electrical parameter of a part of the user's body, such as electroencephalography (EEG), skin conduction response (SCR), impedance plethysmography (IPG), electromyography (EMG), etc.

[0057] Based on the features taught herein, system 101, and specifically electronic circuitry 106, can be adapted to apply transcranial electrical stimulation using suitable methods, such as transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial random noise stimulation (tRNS). In the context of treatment or application of electrical stimulation involving the user's head or scalp, the terms 'transcutaneous' and 'transcranial' are used interchangeably. The term 'transcutaneous' as used herein should be understood in its broad sense and, in particular, includes the skin of the forehead, i.e., the area of ​​the user's 'face' above the user's eyes.

[0058] As can be seen, electronic circuitry 106 may include one or more of the following: microcontroller 108, high-voltage circuitry 110, stimulation circuitry 112, internal power supply 114, radio frequency (RF) transceiver 116, analog signal processing circuitry 118, rechargeable battery 120 electrically associated with charging circuitry 122, sensor array 124, and user interface 134, wherein sensor array 124 includes one or more of accelerometer 126, temperature sensor 128, pressure sensor 130, and humidity sensor 132.

[0059] In some embodiments, electronic circuitry 106 may be electrically associated with and powered by rechargeable battery 120, which is electrically connected to internal power supply 114. In some embodiments, internal power supply 114 supplies power to high-voltage circuitry 110, which is in turn electrically connected to stimulation circuitry 112. Charging circuitry 122 is electrically associated with rechargeable battery 120 and may interface with external power source (e.g., charger 140). High-voltage circuitry 110 supplies current to stimulation circuitry 112 at a voltage ranging from 1 to 150 V. In some embodiments, rechargeable battery 120 may be replaced by a consumable battery configured to operate within the same voltage and current range.

[0060] In some implementations, the stimulation circuit 112 receives information and / or commands from the microcontroller 108. The stimulation circuit 112 is configured to deliver electrical stimulation pulses to the user's neural tissue via the stimulation electrode 102.

[0061] The stimulation circuit 112 can be configured to generate two-phase, charge-balanced electrical pulses, single-phase electrical pulses, and / or DC stimulation.

[0062] According to another feature of the described embodiment, the stimulation circuit 112 can be configured to generate electrical stimulation in an intensity range of 0-60mA, 0-40mA, 0-20mA, or 0-15mA.

[0063] According to another feature of the described embodiment, the stimulation circuit 112 can be configured to generate stimulation pulses with durations of 10-1000 μsec, 50-600 μsec, and 100-500 μsec.

[0064] According to another feature of the described embodiment, the stimulation circuit 112 can be configured to generate stimulation pulses with frequencies of 1-20,000Hz, 1-10,000Hz, 1-500Hz, 10-300Hz, 10-250Hz, 20-180Hz, 30-180Hz, or 40-100Hz.

[0065] In some embodiments, electronic circuit 106 may include two or more high-voltage circuits (not shown) similar to circuit 112, each high-voltage circuit providing a current of 1-150V, 1-120V, or 1-100V to at least two of the stimulating electrodes 102. In some embodiments, electronic circuit 106 may include at least two isolated output channels (not shown), each output channel providing an output to at least two of the stimulating electrodes 102.

[0066] In some embodiments, electronic circuitry 106 also includes feedback and measurement circuitry 142, which collects voltage or current level information from stimulation electrode 102 and provides the collected information to microcontroller 108. Microcontroller 108 uses the provided feedback via stimulation circuitry 112 to monitor and control the voltage and current levels in stimulation electrode 102. In some embodiments, microcontroller 108 may alert the user, for example, by providing auditory or tactile indications, or may suspend the supply of stimulation current in emergency situations or in cases of system malfunction.

[0067] In some implementations, the microcontroller 108 may instruct the stimulation circuit 112 to output current in various forms and / or at various time periods, and / or may instruct the stimulation circuit 112 with respect to various stimulation parameters, such as the current amplitude, pulse frequency, phase duration, and amplitude of the current output by the stimulation circuit.

[0068] In some embodiments, the microcontroller 108 may instruct the stimulation circuit 112 to provide different types of output signals to each of a plurality of activated pairs of electrodes. For example, the stimulation circuit 112 may stimulate one pair of electrodes with a pulse frequency of 50 Hz and a phase duration of 300 μsec and stimulate another pair of electrodes with a pulse frequency of 100 Hz and a phase duration of 200 μsec. In some embodiments, at any given time, the microcontroller 108 may activate only one pair of electrodes, may activate a combination of electrodes, and / or may activate several electrodes simultaneously, sequentially or alternately.

[0069] In some embodiments, some electrodes 102 may provide an AC signal as an output, while other electrodes 102 may provide a DC signal as an output. In some embodiments, at least two electrodes 102 may alternate between AC and DC current types provided as outputs.

[0070] In some implementations, during a DC stimulation of the brain based on the polarity of electrodes positioned above certain areas of the brain to determine the excitation of said areas, the microcontroller 108 may assign at least one electrode 102 to an anode or a positively charged electrode, and may assign at least one other electrode 102 to a cathode or a negatively charged electrode.

[0071] In some embodiments, the stimulation pattern determined or assigned by the microcontroller 108, and the feedback data received from the electrode 102 and / or from the sensing electrode 104, may be stored in the microcontroller 108 or in volatile or non-volatile memory (not shown) associated with the microcontroller 108. In some embodiments, the stored stimulation pattern may be used to formulate a personalized neurostimulation therapy protocol.

[0072] In some embodiments, electronic circuitry 106 may be configured to receive analog signal inputs from one or more sensors (e.g., sensing electrodes 104), such as electroencephalogram (EEG) signals, skin conduction response (SCR) signals, impedance plethysmography (IPG) signals, electromyography (EMG) signals, or other biosignals that may indicate the impedance of the tissue receiving the neural stimulation signal, the charge supplied to the tissue, etc. Analog signal processing circuitry 118 may process the analog signal inputs received from sensing electrodes 104 and may transmit the analog signal inputs from analog signal processing circuitry 118 to microcontroller 108. In some embodiments, electronic circuitry 106 may be configured to receive digital, analog, or other inputs from additional sensors adapted to sense a region near the user or its characteristics. In some embodiments, microcontroller 108 may alert one or more stimulation parameters due to inputs received from one or more of the additional sensors, as described below.

[0073] In some embodiments, the accelerometer 126 or any other suitable orientation sensor may be configured to sense the angular position of the user's head or the device embody system 101 (and more specifically, the portion therein that engages with the user's head), thereby enabling the microcontroller 108 to recognize changes in the user's and / or system's condition and adjust or adapt the pulses provided by the stimulation electrodes 102. For example, a change in user position may cause a change in the pressure applied to the electrodes, thus altering the proximity of the electrodes to the user's skin and consequently changing the impedance in the system, and requiring adjustment of the pulses applied to the tissue via the electrodes, as described below. In some embodiments, in addition to the motion and orientation information provided by the accelerometer 126, a vibrating structure microelectromechanical system (MEMS) gyroscope 127 may also be configured to provide angular motion information.

[0074] In some embodiments, the temperature sensor 128 may be configured to sense the temperature in the vicinity of the system 101 or the stimulation electrode 102, thereby enabling the microcontroller 108 to recognize changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulation electrode 102. For example, an increase in temperature in the vicinity of the user or electrode 102 may cause the electrode or conductive material applied to the electrode to dehydrate more rapidly, thus increasing the impedance in the system and requiring adjustment of the pulses applied to the tissue via the electrode, as described below.

[0075] In some implementations, the pressure sensor 130 may be configured to sense pressure applied to the user's head in the vicinity of the electrode 102 or directly to the electrode 102, thereby enabling the microcontroller 108 to recognize changes in the user's condition and / or system condition, and to adjust or adapt the pulses provided by the stimulating electrode 102. For example, an increase in the amount of pressure applied to the electrode 102 to push the electrode 102 toward the user's scalp is expected to reduce the distance between the electrode and the scalp, and in some cases, reduce the distance between the electrode and the target nerve, thereby reducing impedance in the system and requiring or allowing adjustment of the pulses applied to the tissue via the electrode.

[0076] In some implementations, the humidity sensor 132 may be configured to sense the humidity or moisture level in the vicinity of the system 101 or the stimulation electrode 102, thereby enabling the microcontroller 108 to recognize changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulation electrode 102.

[0077] In some implementations, the user interface 134 may be configured to receive from the user an indication of a sensation the user is experiencing, such as a pain indication, a discomfort indication, or an indication of decreased or absent sensory abnormalities (tactile sensation). This indication of a change in the user's perceived sensation may enable the microcontroller 108 to adjust or adapt the pulses provided by the stimulation electrode 102, or to assess sensory and therapeutic thresholds and user calibration of those thresholds, as will be described elsewhere in this disclosure.

[0078] In some implementations, RF transceiver 116 enables microcontroller 108 to communicate via radio frequency with an interface of external device 150 (e.g., a mobile phone, tablet computer, computer, or cloud-based database). RF transceiver 116 can transmit digital information to and receive digital information from microcontroller 108, such as the personalization of neurostimulation therapy provided by system 101. RF transceiver 116 can operate to transmit / receive using any of the wireless communication protocols known in the art, including but not limited to Wi-Fi, WLAN, PDA, VoIP, and Bluetooth.

[0079] The interface of device 150 may include software applications downloadable from easily accessible resources (e.g., from the Internet). The interface may, for example, provide its user with indications of the status of system 101 via a display, including information related to effective stimulation channels, stimulation intensity, effective procedures, treatment time, battery status, and RF communication status, as well as various warnings, such as those related to electrode contact quality and proper or improper system alignment on the head. Additionally, the interface may, for example, provide the user with usage logs and / or reports via a display, such as information related to daily stimulation times, stimulation parameters used during stimulation, and the treatment procedures used. The interface may also display or otherwise provide the user with raw or processed information received from sensors included in or associated with the device.

[0080] In some implementations, the system can be remotely controlled via an interface of external device 150. For example, the external interface may allow its user to start or stop the system, begin or pause stimulation, adjust the stimulation intensity of one or more channels, and select treatment programs. In some implementations, information collected by microprocessor 108 can be transmitted via the external interface to a remote location where information can be stored or analyzed and / or monitored, such as a cloud-based portal.

[0081] Now for reference Figure 2A , Figure 2AThe diagram illustrates several components of a neurostimulation therapy system. An earpiece 100 is mounted on the user's head 90. In some embodiments, the earpiece 100 may be configured to wirelessly communicate with one or more external devices 150 using a communication channel 80. Any communication channel 80 may utilize any combination of direct inter-device communication (e.g., via Wi-Fi, Bluetooth, IR, or any other wireless inter-device communication or wired communication) and indirect communication (e.g., routed via a server and / or router and / or other LAN and Internet devices).

[0082] An example of external device 150 is a remote control 560, which can be used by a user to send commands and other inputs to headset 100. Remote control 560 can also present the user with various visual and audio indicators regarding the status of headset 100. Alternatively, headset 100 can be configured to communicate wirelessly with mobile phone 570. The mobile phone interface can be used to present various data wirelessly transmitted by headset 100, such as visual and audio indicators regarding the status of headset 100 and usage logs. An exemplary handheld device (e.g., Figure 2B As shown in the block diagram of the mobile phone 570, the mobile phone 570 includes a non-transitory computer-readable storage medium 50, on which program instructions 51 are stored, which are executed by one or more processors 54 of the mobile phone 570. The program instructions 51 can cause the mobile phone 570 and / or the headset 100 to control the neurostimulation therapy phase, including, for example, determining therapy protocol parameters before the therapy phase, capturing user instructions and other inputs, and / or determining therapy protocol parameters. Figure 2B The mobile phone 570 further includes a communication arrangement 53 for communicating with the headset 100 (especially) and a user interface 52, which may include a touchscreen. The user interface 52 can be used for any form of interaction between the user and a software program including program instructions 51, and the user interface 52 can be used to present various data wirelessly transmitted by the headset 100, such as visual and audio indications of the status of the headset 100 and usage logs.

[0083] Still referencing Figure 2A Alternatively, the headset 100 can be configured to communicate wirelessly with the laptop computer / PC 580. Like the mobile phone 570, the laptop computer / PC 580 can be configured with a non-transitory computer-readable storage medium containing the stored program instructions 51 described above.

[0084] Figure 2AAny or more of the illustrated 'user input devices' 150 (phone 570, remote control 560, and PC / laptop computer 580) may be used interchangeably when performing the methods disclosed herein. The headset 100 suitable for performing the methods disclosed herein includes any of the headsets disclosed in the following patents: the applicant's patents US 9,433,774 and US 9,872,979, and the applicant's co-pending US patent application 15 / 510,067, filed September 16, 2015 and published as US 20170296121; 16 / 070,563, filed January 26, 2017 and published as US 20190022372; and 16 / 093,094, filed April 9, 2017 and published as US 20190117976.

[0085] Now for reference Figure 3 , Figure 3 Is to implement Figure 1 A perspective view schematically illustrates a non-limiting exemplary embodiment of the earphone 100 of system 101. As seen, the earphone 100 may be configured to include a front component 162 connected to a pair of flexible arm components 164, which may also be referred to as transition components, each terminating in a rear component 166. The front component 162, the flexible arm components 164, and the rear component 166 together form the body of the earphone. In some embodiments, the electrode system 172 may include a front electrode adapted to be located in the supraorbital region of the head above the branches of the trigeminal nerve to stimulate the branches of the trigeminal nerve, or may be an electrode adapted for transcranial stimulation of the frontal and prefrontal regions of the brain. In some embodiments, the electrode system 174 may include a rear electrode adapted to be located in the occipital region of the head above the branches of the occipital nerve to stimulate the branches of the occipital nerve, or may be an electrode adapted for transcranial stimulation of the occipital region of the brain.

[0086] It will be understood that the headset 100 may include additional electrodes having a similar structure and / or function to the electrodes of electrode systems 172 and 174. Further, it will be understood that electrode systems 172 and / or 174 may be removed or moved to other locations on the headset 100 suitable for stimulating specific nerves or groups of nerves or specific brain regions. For example, electrode system 174 may be moved along the flexible arm component 164. As another example, the headset 100 may include only a single pair of electrode systems located on the arm component 164, said electrodes being configured to be positioned below the evoked area when the headset is worn, while electrode systems 172 and 174 may be removed. In some embodiments, the electrodes may be oriented to stimulate nerves located in lateral areas of the brain, or alternatively, to stimulate anterior and / or posterior nerves.

[0087] The front component 162 can be configured to contain and Figure 1 Electronic circuit 106 is similar to electronic circuit 176, which can be configured to be electrically coupled to power supply 177 via conductive wiring (not shown). Figure 1 The battery 120 (similar to a battery) and electrode systems 172 and 174. In some embodiments, at least a portion of the conductive wiring extends via arm member 164 to the rear electrode system 174.

[0088] In some implementations, the electronic circuit 176 and / or battery 177 may be located outside the earphone 100 and / or may communicate remotely with the earphone 100.

[0089] As referenced above Figure 1 As discussed, electronic circuit 176 may include stimulation circuit, microprocessor, charging circuit and user interface.

[0090] In some embodiments, the earphone 100 may be configured to connect to external electronic circuitry and / or stimulation circuitry, thereby transmitting current from an external stimulator to electrode systems 172 and / or 174. In some embodiments, the earphone 100 may be configured to connect to at least one external electrode that may be located in various areas of the body. In some embodiments, the earphone 100 may be configured to connect to external electronic circuitry and a processor to transmit signals from sensors disposed on the earphone 100 to the external processor.

[0091] In some embodiments, the battery 177 may be housed within the front component 162 and can be recharged by plugging a charger into a charging port 178 located on the front component 162 according to some embodiments.

[0092] The front component 162 can also be configured to include on its outer surface a component that can interact with Figure 1 User interface 134 is similar to user controls and interface 180. That is, in some embodiments, other parts of headset 100 (e.g., rear part 166 or arm 164) may be configured to include user interface 180. Some of the functions of on-board (i.e., permanently or removably attached or set) user interfaces 180, 134 may overlap with the functions of user interface 52 of external device 150, such as the ability to receive user input to control neurostimulation therapy or set one or more therapy-related parameters. In some embodiments, the user may use both headset user interface 180 and device user interface 52, while in other embodiments, only one of the two user interfaces 180, 52 may be available to the user.

[0093] Electronic circuitry 176 and user interface 180 can be configured to control and / or activate electrodes included in earphone 100. In some embodiments, user interface 180 is configured to control and / or activate at least two pairs of electrodes, and in some embodiments, to control and / or activate more than two pairs of electrodes. Thus, in some embodiments, stimulation circuitry and / or user interface 180 is configured to activate specific electrodes or specific electrode pairs or channels, multiple electrodes, and adjust the intensity of the current supplied by the activated electrodes or other stimulation parameters of the activated electrodes and provide user indications, such as user indications of pain, user indications of discomfort, or user indications of decreased or increased sensory abnormalities. In some embodiments, any subgroup of electrodes can be activated simultaneously, and in some embodiments, specific subgroups are predefined, for example, during the manufacture of electronic circuitry 176. In some such embodiments, user interface 180 is capable not only of controlling specific electrodes or specific channels but also of controlling activated subgroups of electrodes.

[0094] In some embodiments, the user control and interface 180 includes: a pair of front intensity buttons 181a and 181b for increasing and decreasing the intensity of stimulation provided by the front electrode system 172, respectively; and a pair of rear intensity buttons 182a and 182b for increasing and decreasing the intensity of stimulation provided by the rear electrode system 174, respectively. It will be understood that the user control and interface 180 may include similar intensity buttons for each electrode included in the earphone 100.

[0095] User controls and interface 180 may also include a mode change button 184 for activating and disabling electronic circuitry 176 and for changing between operating modes of the headset 100. For example, the headset 100 may have multiple preset operating modes (e.g., sleep mode, maintenance mode, and treatment mode), and repeated operation of button 184 may switch between these modes in addition to turning the headset on and off.

[0096] For example, a user instruction button that allows users to provide user indications of pain, discomfort, or reduced sensation can be formed as part of the user control and interface 180 and can be mounted on the outer surface of the front component 162.

[0097] In some implementations, the user control and interface 180 may also include an audio element (not shown), such as a speaker or buzzer, which provides the user with auditory instructions for using the headphones 180, such as instructions to turn on the headphones, turn off the headphones, press a button on the interface 180, change the stimulation mode, etc.

[0098] As explained above, the electronic circuitry and user interface are configured to control and / or activate electrodes included in the earphone 100. In some embodiments, the user interface is configured to control and / or activate at least two pairs of electrodes, and in some embodiments, to control and / or activate more than two pairs of electrodes. Thus, in some embodiments, the stimulation circuitry and / or user interface are configured to activate specific electrodes or specific pairs or channels, and to adjust the intensity of the current supplied by the activated electrodes or other stimulation parameters of the activated electrodes. In some embodiments, any subgroup of electrodes can be activated simultaneously, and in some embodiments, specific subgroups are predefined, for example, during the manufacture of the electronic circuitry. In some such embodiments, the user interface is capable not only of controlling specific electrodes or specific channels, but also of activating subgroups of electrodes.

[0099] In some implementations, electronic circuit 176 includes... Figure 1 Transceiver 196 is similar to transceiver 116, which is configured to communicate remotely with external device 150.

[0100] According to embodiments of the present invention, a method for setting treatment parameters for a neurostimulation therapy phase may include: determining a sensory threshold based on coarse electrical stimulation pulses generated by a first plurality of electrodes; testing the reliability of the determined sensory threshold; and confirming the reliability of the determined sensory threshold. At any point in this process, i.e., after determination, testing, or confirmation, a first treatment threshold (recommended initial parameter) may be set based on the sensory threshold. A second treatment threshold may be set based on the first treatment threshold. Setting the second treatment threshold based on the first treatment threshold may be based on a direct relationship between the two, such as an empirically derived direct relationship. The sensory threshold may be one or more treatment parameters indicating to a user that they experience a sensory abnormality (or more generally, any tactile sensation) associated with a series of electrical stimulation pulses provided at a monotonically increasing current intensity.

[0101] The term "treatment parameter" as used in this article may refer to any (or all) of the following:

[0102] - Charge parameter. The charge parameter can be a value of the total charge over a given time period; the given time period is typically an integer multiple of the reciprocal of the frequency of the electrical pulse (which may be referred to as the 'period' of the pulse). For example, if the pulse frequency is 50 Hz, the reciprocal of the frequency is 20 milliseconds (msec), and the chosen given time period could be 1 sec. For greater granular resolution, the given time period can be as short as a single 'period', or in this case, 20 msec. The unit of the charge parameter can be coulombs (or even smaller, millicoulombs) per second, and can be calculated by averaging or integrating the current delivered over the given time period (e.g., in milliamperes).

[0103] - Current intensity parameters, such as the peak current, average current, or steady-state current of an electrical pulse.

[0104] - Pulse duration parameter and frequency parameter, or an arithmetic combination thereof. Pulse duration, also known as pulse width, is typically measured in microseconds (μsec). The pulse duration can be parameterized by combining the period (the reciprocal of the frequency), for example, to derive a proportion of each cycle of the applied pulse. For instance, a pulse duration (pulse width) of 500 μsec at a frequency of 50 Hz means that a pulse is being applied with a period of 0.5 msec / 20 msec, or 2.5% of that time.

[0105] It is conceivable to use any two or more of the aforementioned electrical parameters to characterize a series of pulses. For example, the ratio of current intensity to charge, or the ratio of current intensity to the reciprocal of pulse duration to frequency, and the ratio of charge to the reciprocal of pulse duration to frequency are three exemplary sets of electrical parameters that can be used to characterize a series of pulses. Those skilled in the art will understand that any of the aforementioned sets can also be used to calculate other parameters: for example, if the average current intensity and charge / period of the pulse are known, the proportion of time the pulse is applied (outside of each period) can be calculated.

[0106] In some instances, current intensity is used herein to illustrate electrical parameters used in various implementation schemes, such as the use of a monotonically increasing current intensity in methods for setting, testing, validating, or calibrating sensory thresholds. In this instance, the illustrative use of current intensity is not intended to be limiting, and other electrical parameters or groups of parameters may be used in place of current intensity where applicable.

[0107] In an exemplary implementation, a front electrode (e.g., Figure 3 The electrical stimulation pulse generated by electrode 172 measures the sensory threshold. In other embodiments, an additional or alternative option is that the electrode can be placed laterally, but... Figure 3 Not shown in the image.

[0108] In this embodiment, the first treatment threshold can therefore be correlated with the forward guiding pulse of the treatment protocol and can be calculated from the sensory threshold using a first empirically derived direct relationship. In this embodiment, the second treatment threshold can be correlated with the backward guiding pulse of the treatment protocol and can be calculated from the first treatment threshold using a second empirically derived direct relationship. In some other embodiments, the first treatment threshold can be correlated with the backward guiding pulse of the treatment protocol, and the second treatment threshold can be correlated with the forward guiding pulse of the protocol. In other embodiments, the first and second treatment thresholds can be correlated with the forward guiding pulse and the lateral guiding pulse; correlated with the backward guiding pulse and the lateral guiding pulse; correlated with the lateral guiding pulse and the forward guiding pulse; correlated with the lateral guiding pulse and the backward guiding pulse; or correlated with the lateral guiding pulse on the opposite side of the user's head. The first and second direct relationships can be empirically derived relationships based on treatment thresholds known to be within the effective range, provided the current intensity is above the minimum required to achieve a noticeable sensory abnormality and below the threshold causing pain or excessive discomfort to the user. Any of the above steps can be performed using a head-mounted device (including any of the headphones 100 discussed herein). According to a preferred embodiment, prior to the treatment phase, the user can 'calibrate' the initial treatment parameters (e.g., current intensity or pulse frequency) by increasing or decreasing the treatment parameters based on (in particular) user comfort, i.e., the first and second treatment thresholds set according to the foregoing discussion. An embodiment of the method can be implemented by executing program instructions 51 stored on an external device 150 (e.g., mobile phone 570), the execution of which is performed by one or more processors of the device 150, as described later in this disclosure.

[0109] Now for reference Figures 4 to 9 The diagram illustrates flowcharts of methods and method 'components' related to defining and setting user-specific sensory and therapeutic thresholds according to various embodiments of the invention. As can be seen, each component (a group of one or more method steps) is labeled with a box code (e.g., box A, etc.) to simplify the following diagrams presenting different combinations of method component boxes as discussed below. Each component includes a brief text description (e.g., box A (device on head)) to be included in Figures 14 to Figure 19 The flowcharts are easy and convenient to identify, with boxes grouped into various combinations. However, the brief text descriptions next to the box numbers are only for easier understanding of Figures 14 to 15. Figure 19 The methods and components provided are not intended to illustrate or limit the scope of the corresponding method steps and components. Any one of the individual components can constitute a method according to the invention, and any combination of components can be combined to constitute a method according to the invention, whether or not the method is explicitly illustrated and / or described herein.

[0110] Now for reference Figure 4 'Frame A (Device on Head)' includes step S01, which includes mounting a device comprising electrodes on the user's head, the electrodes being configured to provide electrical stimulation pulses of the type used in percutaneous nerve stimulation therapy. In some embodiments, the device includes electrodes and wiring connecting the electrodes to a power source. In some embodiments, the device further includes a control circuitry system. The device may further include elements for holding the electrodes in place to contact the user's scalp, such as a headband or retractable band. In some embodiments, the device may be headphones, such as any of the headphones 100 previously discussed in this disclosure. When the term headphones is used hereinafter, the term should be understood to include: other equipment including electrodes but not necessarily having full-function headphones (e.g., Figure 3 This includes some or all of the devices shown in the example of the headset 100. In some embodiments, additionally or alternatively, block A includes step S01a, which includes confirming that the device is mounted on the user's head. For example, step S01 is most likely to be performed if the user is not wearing the device. In contrast, step S01a is most likely to be performed if the user is wearing the device. Of course, both step S01 (user wearing the device) and step S01a (confirming device wearing) may be performed. In some embodiments, the confirmation includes program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). In some such embodiments, the confirmation may include receiving confirmation information from a sensor (e.g., sensing electrode 104). In other such embodiments, the confirmation may include receiving user input on the user interface 52 of the mobile device 570. The confirmation may additionally include requesting user input on the user interface 52 before receiving user input. Alternatively or alternatively, the confirmation may include receiving user input via an onboard interface 180.

[0111] like Figure 5 As illustrated in the diagram, box B (limited sensory threshold) includes a group of method steps for determining the sensory threshold of a particular user.

[0112] In step S05, a series of electrical stimulation pulses is provided by a set of stimulation electrodes 102 – in some embodiments, the set of stimulation electrodes 102 includes multiple pre-electrodes. The series of electrical stimulation pulses preferably begins with micropulses, i.e., pulses below a selected electrical parameter (e.g., a current intensity threshold or 'charge within a time threshold') that allows the user to experience any tactile sensation associated with the pulse. The pulses then monotonically increase in the selected electrical parameters as the series of electrical stimulation pulses progresses. In some embodiments, other pulse parameters (e.g., pulse width, phase width, and frequency) remain constant.

[0113] Step S06 includes receiving a user input indication that the user has experienced dermal sensation (e.g., paresthesia) associated with the series of pulses. An alternative step S06' includes receiving a user input indication that the user has experienced dermal sensation associated with the series of pulses during a series of electrical stimulation pulses applied over time by multiple stimulation electrodes 102 to one or more specific areas (e.g., the anterior scalp). Step S06' may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). The user input for step S06 or step S06' is preferably received via the user interface 52 and / or onboard interface 180 of the mobile device 570.

[0114] Note: Reference numerals used in this disclosure include cases where an apostrophe follows a number (e.g., S06'), indicating an alternative version of the apostrophed number indicating a step (e.g., S06), which is particularly intended to be included in program instructions executed by one or more processors of a user input device (e.g., a mobile phone). In each case, the technical concept is the same for each of the pairs of corresponding steps (e.g., like S06 and S06').

[0115] In response to receiving a first user input in step S06 or step S06', a sensory threshold is defined in step S07, wherein the sensory threshold for any electrical parameter or any set of electrical parameters is equal to the corresponding parameter value received from the user input. In other words, the sensory threshold corresponds to the electrical parameters for which the user experiences noticeable dermal sensation (e.g., sensory abnormality) from a series of electrical stimulation pulses.

[0116] refer to Figure 6 Box C (Setting the First Treatment Threshold) includes step S08, which involves setting the first treatment threshold based on a relationship between the first treatment threshold and a sensory threshold. In a preferred embodiment, the relationship is a direct relationship derived from empirical data. The first treatment threshold may be a treatment threshold for electrical stimulation pulses provided by a specific plurality of electrodes (e.g., electrode 172) pointing towards one or more specific areas of the scalp. In some embodiments, the first treatment threshold is associated with a pre-electrode 172 that generates electrical stimulation pulses pointing towards an anterior region of the scalp (including, for example, a portion of the forehead). The treatment threshold may include a value or range of current intensity considered to provide effective percutaneous nerve stimulation therapy. For example, it has been found that the treatment threshold may be higher than a minimum perceived sensory abnormality and lower than a maximum perceived pain and / or discomfort by the user. In some embodiments, the value of the treatment threshold is determined empirically by testing the user against the minimum and maximum values.

[0117] Example 1

[0118] In this example, the direct relationship between the first therapeutic threshold and the sensory threshold was empirically established using a sample group of 24 users of the transcutaneous nerve stimulation headphone 100. The table below summarizes the sensory threshold (Tto) in milliamperes (mA), which is defined for each user according to the instruction in step S07; the first therapeutic threshold (Tt) in mA; and the ratio of Tt to Tto for each user.

[0119] user# Gender (M / F) Tto(mA) Tt(mA) Tt / Tto 1 F 1.2 2.1 1.7 2 F 1.3 2.2 1.7 3 F 1.2 1.9 1.6 4 F 1.2 3.3 2.8 5 F 1.1 1.8 1.6 6 F 1.2 1.8 1.5 7 F 1.6 2.8 1.8 8 F 1.6 2.6 1.6 9 F 1.8 2.4 1.3 10 F 1.3 1.7 1.3 11 F 1.3 1.9 1.4 12 F 1.8 3.0 1.7 13 M 1.7 3.3 1.9 14 M 1.7 2.5 1.4 15 M 1.7 2.7 1.6 16 M 1.2 2.4 1.9 17 M 1.3 2.3 1.8 18 M 1.3 2.7 2.1 19 M 1.4 2.0 1.5 20 M 1.2 2.7 2.3 21 M 1.3 2.5 1.9 22 M 2.0 2.9 1.5 23 M 1.6 3.1 1.9 24 M 2.1 3.2 1.5

[0120] Based on the results from 24 users, we can see that the ratio of Tt to Tto has a minimum of 1.3, a maximum of 2.8, and an average of 1.7.

[0121] The first treatment threshold in step S08 can be calculated by multiplying the user's defined sensory threshold by a multiplier A, based on the relationship between Tt and Tto observed in empirical data. The multiplier A, based on empirical data, can be set entirely within a range encompassing the corresponding preferred treatment threshold for all or most users. For example, A can be in the range of 1.0 to 3.2, inclusive; the preferred treatment threshold for all 24 users in Example 1 is found to be within this range. Alternatively, A can be set entirely within the range of 1.3 to 2.8, inclusive; and the preferred treatment threshold for all 24 users in Example 1 is found to be within this range. Another option is to set A entirely within the range of 1.4 to 2.0, inclusive; 19 out of 24 users have an optimal treatment threshold within this range. Yet another option is to set A entirely within the range of 1.3 to 1.9; 21 out of 24 users have an optimal treatment threshold within this range. Alternatively, or additionally, the relationship between Tt and Tto may include other electrical parameters, such as any of the electrical parameters discussed above.

[0122] Steps S07 and S08 may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570).

[0123] In some implementations, it may be desirable to test the reliability of the sensory threshold (i.e., the current intensity of the current received when a user indication perceived by skin is received (i.e., the first user input received in step S06 or S06'). Figure 7 Box D (Determining Reliability), illustrated in the diagram, includes methodological steps designed to test the reliability of sensory thresholds.

[0124] In step S101, a series of additional electrical stimulation pulses are provided by multiple electrodes (e.g., the same multiple electrodes used for the pulses in step S05). Step S102 includes receiving additional user input indicating that the user has experienced dermal sensation (e.g., sensory abnormality) associated with the series of additional pulses in step S101.

[0125] Alternative step S102' includes receiving additional user input indicating that the user has experienced dermal sensation associated with a series of pulses during a series of additional electrical stimulation pulses applied by a plurality of stimulation electrodes 102 to one or more specific areas (e.g., the anterior region) of the user's scalp. Step S102' may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). The current intensity of the pulses in step S101 or step S102' increases monotonically with the progression of the series of pulses at an increase rate that may be the same as or different from the increase rate of the first series of pulses in step S05 or step S06'. The user input in step S101 or step S102' is preferably received via the user interface 52 and / or the onboard interface 180 of the mobile device 570.

[0126] Once additional user input is received in step S101 or S102', the reliability of the sensing threshold can be determined in step S103. This may include comparing the current intensity of the received additional user input with the sensing threshold defined in step S07. Steps S103 and S08 may be included in program instructions 51 executed by one or more processors 54 of the user input device (e.g., mobile phone 570). In some embodiments, if the current intensity of the additional user input is within the sensing threshold defined in step S07... ± If the sensitivity threshold is within 10%, it can be determined that the perception threshold is reliable. In some implementations, if the intensity of the additional user input current is within the sensitivity threshold defined in step S07, then... ± If the sensitivity threshold is within 20%, it can be determined that the perception threshold is reliable. In some implementations, if the intensity of the additional user input current is within the perception threshold defined in step S07, then... ± If the percentage is within 30%, then the sensory threshold can be determined to be unreliable.

[0127] As discussed later, the steps in box D can be repeated any number of times to test the reliability of the user's sensory threshold. If the reliability of the sensory threshold cannot be determined after the required number of repetitions, a treatment protocol based on default values ​​can be developed and / or implemented. Default values ​​can be modified based on stored user information.

[0128] In some implementations, it may be desirable to verify the reliability of the sensory threshold (i.e., the current intensity of the received tactile indication (i.e., the first user input received in step S06 or S06'). Figure 8 Box E (Verification of Reliability) illustrated in the diagram includes methodological steps aimed at verifying the reliability of the sensory threshold.

[0129] In step S201, a series of additional electrical stimulation pulses are provided by multiple electrodes (e.g., the same multiple electrodes used for the pulses in step S05). In some embodiments, the pulses may be provided by multiple electrodes different from those used for the pulses in step S05. In examples, the pulses in step S05 may be provided by a preceding set of electrodes, and the pulses in step S201 may be provided by a subsequent set of electrodes. As discussed below, there may be a direct relationship between a corresponding set of treatment parameters for the preceding set of electrodes and a corresponding set of treatment parameters for the subsequent set of electrodes, and in some embodiments, there may be an empirically derived relationship to complement the use of different multiple electrodes in step S201. Step S202 includes receiving additional user input indicating that the user has experienced dermatoglyphics, such as sensory abnormalities, associated with the series of additional pulses in step S201. Alternative step S202' includes receiving additional user input indicating that the user has experienced dermal sensation associated with a series of pulses during a series of increasing current intensity applied by multiple stimulation electrodes 102 to one or more specific areas (e.g., the anterior scalp). Step S202' may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). The user input in step S201 or step S202' is preferably received via the user interface 52 and / or onboard interface 180 of the mobile device 570.

[0130] The current intensity of the pulse in step S201 or step S202' increases monotonically with the progression of the series of pulses at a rate that may be the same as or different from the rate of increase of the first series of pulses in step S05 or S06'. Compared to the other steps, the pulse in step S201 or step S202' is interrupted by a pause before the current intensity increases to the level of the sensory threshold defined in step S07. Preferably, the pause occurs a sufficiently long time before reaching the sensory threshold level, such that the current intensity is substantially different from the current intensity of the sensory threshold (e.g., within 10%, 20%, or 30% of the sensory threshold). After a pause that may be less than 1 second, 1 second, or greater than 1 second or several seconds, the series of pulses (and the current intensity increases) continues until user input indicating that the user has experienced tactile sensation (e.g., sensory abnormality) is received in step S202 or step S202'. If user input (within an acceptable range between the current intensity value and the sensory threshold) is received after the pulse resumes following a pause, as per step S202 or S202', the sensory threshold is confirmed in step S203. Conversely, if user input (as per step S202 or S202') is received before or during a pause (i.e., just before the pulse reaches the sensory threshold defined in step S07), the sensory threshold is not confirmed in step S204.

[0131] Steps S203 and S204 may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570).

[0132] As will be discussed later, the method steps in box E can be performed after the steps in box B (defining the sensory threshold) or after one or more cycles / repetitions of box D (determining the reliability of the sensory threshold). In some embodiments, box E can preferably be performed before box C (setting the first treatment threshold).

[0133] Now for reference Figure 9Box F (Setting the Second Treatment Threshold) includes step S301, which involves setting a second treatment threshold based on a relationship between the second treatment threshold and a first treatment threshold. In a preferred embodiment, the relationship is a direct relationship derived from empirical data. The second treatment threshold may be a treatment threshold for electrical stimulation pulses provided by a specific plurality of electrodes (e.g., electrode 174) directed to one or more specific areas of the scalp. In some embodiments, the second treatment threshold is associated with a rear electrode 174 that generates electrical stimulation pulses directed to the posterior region of the scalp. The treatment threshold may include a value or range of current intensity considered to provide effective transcutaneous nerve stimulation therapy. For example, it may be found that the treatment threshold can be higher than a minimum value for which the user perceives sensory abnormalities and lower than a maximum value for which the user experiences pain and / or discomfort. In some embodiments, the value of the treatment threshold is determined empirically by testing the user against the minimum and maximum values.

[0134] Example 2

[0135] Example 2 is an extension of Example 1. The direct relationship between the second treatment threshold and the first treatment threshold is empirically established using the same sample group of 24 users of the transcutaneous nerve stimulation headset 100. The table below summarizes the first treatment threshold (Tt) in milliamperes (mA), the second treatment threshold (Ot) in mA, and the ratio of Ot to Tt for each user as taught in step S07.

[0136]

[0137]

[0138] The results from 24 users show that the ratio of Ot to Tt has a minimum of 1.9, a maximum of 3.4, and an average of 2.4.

[0139] The second treatment threshold in step S301 can be calculated by multiplying the user's first treatment threshold by a multiplier B, based on the relationship between Ot and Tt observed in empirical data. The multiplier B, based on empirical data, can be set entirely within a range encompassing the corresponding preferred treatment thresholds for all or most users. For example, B can be in the range of 1.1 to 3.8, inclusive; the preferred treatment thresholds for all 24 users in Example 2 are found to be within this range. Alternatively, B can be set entirely within the range of 1.4 to 3.4, inclusive, and the preferred treatment thresholds for all 24 users in Example 2 are also found to be within this range. Another option is that B can be set entirely within the range of 1.8 to 3.0, inclusive; within this range, 21 of the 24 users have optimal treatment thresholds. Alternatively, or additionally, the relationship between Ot and Tt can include other electrical parameters, such as any of the electrical parameters discussed above.

[0140] Step S301 may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570).

[0141] Now for reference Figures 10 to 13 The diagram shows flowcharts and 'component blocks' of method steps, particularly related to calibrating treatment thresholds, according to various embodiments of the present invention.

[0142] refer to Figure 10 The frame G (device on the head) includes step S305, which includes attaching a device comprising electrodes to the user's head, the electrodes being configured to provide electrical stimulation pulses of the type used in percutaneous nerve stimulation therapy. In embodiments, the device may be an earphone, such as any of the earphones 100 previously discussed in this disclosure; the device may be a reference... Figure 4The devices described herein and the preceding discussion of box A in this disclosure. The devices may be the same devices used in box A and may remain in place from the start of performing the steps of box A (and / or any other method steps). In some embodiments, additionally or alternatively, box G includes step S305a, which includes confirming that the device is mounted on the user's head. In some embodiments, the confirmation includes program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). In some such embodiments, the confirmation may include receiving confirmation information from a sensor (e.g., sensing electrode 104). In other such embodiments, the confirmation may include receiving user input on the user interface 52 of the mobile device 570. The confirmation may additionally include requesting user input on the user interface 52 before receiving user input. Alternatively or alternatively, the confirmation may include receiving user input via an onboard interface 180.

[0143] In some implementations, it may be desirable for a user to calibrate the treatment thresholds set in steps S08 and S301 during a dedicated calibration phase. User calibration may include changing treatment protocol parameters (e.g., current intensity) to increase treatment comfort. In some cases, the user may preferentially increase the current intensity, and in others, may preferentially decrease the current intensity or modify another electrical parameter. For example, reducing the charge over time may include increasing the current intensity by 5% but shortening the pulse duration by 10%. In other examples, the user may wish to make the electrical stimulation pulses for percutaneous nerve stimulation treatment shorter or longer, and / or more frequent or less frequent. In some implementations, system 101 may be configured to receive this calibration input from the user and, in response, make the requested change very quickly (e.g., within 1 second, or less than 500 milliseconds, or less than 200 milliseconds after the user completes the change). In some implementations, system 101 may be configured to adjust not only the value of the parameter directly changed by the user, but also the value of at least one additional parameter in response to the user calibration input. For example, if the user changes the value of the current intensity treatment protocol parameter, system 101 can be configured to adjust one or more of, for example, pulse width (duration), phase width, and / or frequency. These one or more additional parameters can change automatically in response to user calibration input to achieve a treatment goal. For example, the treatment goal could be to maintain the overall average current such that the overall average current remains at a predetermined value during treatment. (One way to calculate the average current is to multiply the current intensity by the ratio of the phase width to the pulse width, where the average current is typically measured in milliamperes). Therefore, decreasing the current intensity can trigger an increase in the phase width. As another example, the treatment goal could be to maintain the average current within an acceptable variation of a predetermined value (e.g., ± 30% ±20% or ± (10%). In both of these examples, the predetermined value can be the overall average current value before the user calibrates the input.

[0144] In some embodiments, the treatment phase can be performed immediately after a dedicated user calibration phase, and in other embodiments, the calibration phase can be an independent interaction with system 101 and its components (e.g., headset 100), wherein the mobile device 570 is used as a user input device by executing command program instructions 51 by one or more processors 54. In some embodiments, the calibration phase can be performed immediately or shortly after performing step S301 (setting a second treatment threshold).

[0145] Now for reference Figure 11 Box H (Change Treatment Threshold) includes a group of method steps related to user calibration of the treatment threshold.

[0146] In step S310, the calibration phase is initiated; in some embodiments, the baseline (initial) treatment threshold is the treatment threshold set in steps S08 and S301, and in some other embodiments, one or both of the initial treatment thresholds have been changed in a previous calibration phase. Calibration can be initiated by the user, or it can be initiated by the system running an application (executing program instructions 51) on a user input device (e.g., mobile device 570). According to embodiments, electrical stimulation pulses are delivered to two portions of the user's scalp (e.g., the front and back) during the calibration phase.

[0147] Step S311 includes receiving user calibration input from the user, where the value of any of the treatment parameters discussed above can be initially changed by the user. An alternative step S311' includes receiving user calibration input after initiating a calibration phase, which uses a first current intensity treatment threshold and a second current intensity treatment threshold, and / or other electrical parameter thresholds, as corresponding initial current intensities applied to two portions (e.g., the front and back) of the user's scalp, or equivalently, current intensity treatment thresholds previously changed by the user in a previous calibration phase. All user inputs, sensory thresholds, treatment thresholds, user calibration inputs, and other data associated with and / or generated by system 101 can be stored in either of the external device 150 and on an external server in the cloud (not shown). Step S311' can be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570). The user calibration input for step S311 or step S311' is preferably received via the user interface 52 and / or onboard interface 180 of the mobile device 570.

[0148] In response to receiving user calibration input during the treatment phase (step S311 or S311'), a change is made to at least one treatment threshold in step S312. As previously discussed, one or more other parameters may be modified to maintain treatment efficacy, for example by keeping the overall average current within a predetermined range. Step S312 may be included in program instructions 51 executed by one or more processors 54 of a user input device (e.g., mobile phone 570).

[0149] Now for reference Figure 12 , Figure 12 The method step block I (outside of the range indication) includes step S320. In some embodiments, another option, or additional step S320, includes providing the user with an indication that a change request contained in the calibration user input received during the calibration phase will cause the treatment parameters to be outside the recommended range for effective neurostimulation therapy, in response to receiving user calibration input in step S311 or S311'. The user receiving this indication may be given the opportunity to 'correct' the calibration user input to keep the calibration user input within the recommended range of parameter values, for example, via the user interface 52 of mobile device 570. Step S320 may be included in program instructions 51 executed by one or more processors 54 of the user input device (e.g., mobile phone 570).

[0150] Figure 13 The box J (treatment initiation phase) illustrated in the diagram includes step S401, which involves initiating the percutaneous nerve stimulation treatment phase using one or more treatment parameters that were changed during the calibration phase.

[0151] Refer to Figure 14 Figure 17 Figure 14 to Figure 17 The diagram illustrates the references included in the implementation plan. Figures 4 to 13 Examples of methods that form a framework of steps and procedures.

[0152] Figures 14A to 14D Several options for setting treatment thresholds according to various implementation schemes are shown.

[0153] exist Figure 14A The exemplary method shown includes: installing headphones / confirming that headphones are installed (box A), defining a sensory threshold (box B), setting a first treatment threshold (box C), and setting a second treatment threshold (box F).

[0154] exist Figure 14B Another exemplary method is shown in the figure, which includes: installing headphones / confirming that headphones are installed (box A), defining a sensory threshold (box B), determining the reliability of the sensory threshold (box D), setting a first treatment threshold (box C), and setting a second treatment threshold (box F).

[0155] exist Figure 14C Another exemplary method is shown in the figure, which includes: installing headphones / confirming that the headphones are installed (box A), defining a sensory threshold (box B), confirming the reliability of the sensory threshold (box E), setting a first treatment threshold (box C), and setting a second treatment threshold (box F).

[0156] exist Figure 14D Another exemplary method is shown in the figure, which includes: installing headphones / confirming that headphones are installed (box A), defining a sensory threshold (box B), determining the reliability of the sensory threshold (box D), confirming the reliability of the sensory threshold (box E), setting a first treatment threshold (box C), and setting a second treatment threshold (box F).

[0157] Figure 15 The diagram illustrates another exemplary method, which includes: installing headphones / confirming that the headphones are installed (box A); defining a sensory threshold (box B); and determining the reliability of the sensory threshold (box D), wherein the method step in box D is repeated n times, where n is an integer greater than 1 (n is not greater than 10 in some embodiments, not greater than 8 in other embodiments, and not greater than 6 in other embodiments). If, after n repetitions, the reliability is still not determined to be within a predetermined range in step S103 (e.g., with...), ... ± 30% ± 20% or ± If 10% accuracy (branch Q1) is achieved (repeated sensory threshold), then step S500 is performed, which involves using a set of system default values ​​as the initial (pre-calibrated) treatment threshold. If Q1 is resolved positively, then... Figure 15 The method continues to verify the reliability of the sensory threshold (box E). If the reliability cannot be verified (i.e., step S204 has been performed), then step S500 (restoring to the default initial treatment threshold) is executed. If Q2 is parsed positively, the method further includes performing method steps of setting a first treatment threshold (box C) and setting a second treatment threshold (box F).

[0158] In some embodiments, other combinations of the disclosed method steps and method step blocks may be performed, and all other combinations are within the scope of this invention. For clarity, it is proposed that the method steps of block A may be performed whenever an interruption occurs in the execution of any of the exemplary methods.

[0159] Figures 16 to 17 The diagram illustrates the options for calibrating the treatment threshold according to various implementation schemes.

[0160] exist Figure 16The exemplary method shown includes: installing / confirming that the headphones are installed (box G); changing at least one treatment threshold during the calibration phase (box H); instructing the user that the calibration input will take a value outside the range (box I); and initiating the treatment phase based on one or more values ​​changed during the calibration phase (box J). Not all steps and boxes of the method need to be performed in all embodiments. For example, in some embodiments, only during… Figures 13 to 15 Box G is executed only if the method for positioning the headphones (or an equivalent method) is performed sequentially afterward. Box I is executed only if the received user calibration input will take treatment parameters outside the desired range. Box J is optional and may perform the calibration phase without directly continuing to the actual percutaneous nerve stimulation phase.

[0161] Figure 17 The diagram illustrates another exemplary method, which optionally includes installing / confirming that the headphones are installed (box G) and includes changing at least one treatment threshold during the calibration phase (box H). If the changed received input (in Q3) is outside the range, box I is performed. If the changed received input (in Q3) is not outside the range, the method continues and may optionally perform box J (initiating the actual treatment phase using at least one changed treatment parameter). If box I causes a branch at Q3, step S321 of receiving a new user calibration value can be performed. If a new or 'correct' (within the range) user calibration input has been received in step S321 (at Q4), box J (initiating the actual treatment phase using at least one changed treatment parameter) may optionally be performed; otherwise (i.e., if it is determined at Q4) no new / correct / within the range user calibration has been received, the system defaults to maintaining the previously set treatment threshold in step S501.

[0162] Figure 18 The schematic diagram illustrates another exemplary method, in which reference is made to... Figures 14A to 14D Any of the four methods described can be used with Figure 16 The method is to combine the 'first and last'.

[0163] Figure 19 Another exemplary method is also illustrated schematically, in which... Figure 15 The method can be with Figure 17 The method is to combine the 'first and last'.

[0164] Figures 13 to 19 Any of the methods illustrated herein or their equivalents may be included in program instructions 51 (e.g., applications) executed by one or more processors 54 of the mobile device 570.

[0165] Those skilled in the art will understand that the examples and implementations described herein are not limited to the 'first set the pre-threshold, then set the post-threshold' paradigm used for convenience throughout most of this disclosure.

[0166] For example, a set of backward-oriented electrodes can be used to determine the sensory threshold, and then the sensory threshold can be 'transformed' into a post-treatment threshold and the post-treatment threshold can be 'transformed' into an pre-treatment threshold, with the two 'transformations' being based on an empirically derived relationship between the corresponding current intensity thresholds.

[0167] To give another example, any number of different cranial or peripheral nerves can be targeted as percutaneous nerve stimulation therapy in the desired order, and treatment thresholds can be set according to the desired order based on empirically derived relationships between various areas or nerves (or nerve groups). In some implementations, the target nerve branches may be located laterally on the left and right sides of the user's head.

[0168] The following are examples of the order in which treatment thresholds can be determined for different nerve branches or areas of the user's scalp, with two sets of multiple electrodes targeting two areas of the scalp (A = anterior; P = posterior; LL = left; RL = right): AP; A-LL; A-RL; PA; P-LL; -RL; LL-A; LL-P; LL-RL; RL-A; RL-P; and RL-LL. Clearly, when targeting three or more areas of the scalp and using the corresponding number of electrodes, the number of possible combinations increases accordingly.

[0169] It should also be clear that the implementation scheme is not limited to the user's head, but can be applied to any limb or area of ​​the body, for which empirical relationships between sensory thresholds and therapeutic thresholds, as well as between different therapeutic thresholds, can be derived.

[0170] Any such modifications applied to the methods and apparatus disclosed herein are undoubtedly within the scope of this invention.

[0171] As used herein, whenever it is written that a given method step or a given group of method steps may be 'included' in program instructions, it should be understood that instructions to perform a given method step or a given group of method steps may be included in the program instructions such that execution of the program instructions (e.g., as appropriate, by one or more processors of a computer processor or a mobile device) causes the one or more processors to perform the given method step or a given group of method steps, or causes the one or more processors to perform the given method step or a given group of method steps, as appropriate.

[0172] As used herein in the specification and in the following claims section, the term “or” is considered to include, and therefore the wording “A or B” means any one of the groups “A”, “B”, and “A and B”.

[0173] As used herein in the specification and in the following claims section, the term "pulse" refers to, for example, an electrical signal applied via an electrode or sensed by an electrode.

[0174] It will be understood that certain features of the invention described for clarity in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention described for brevity in the context of a single embodiment may also be provided individually or in any suitable sub-combination. Similarly, the content of a claim according to one or more particular claims may generally accord to another unspecified claim, or be combined with the content of another unspecified claim, without any specific and obvious incompatibility between the aforementioned claims.

[0175] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. An actuation method for a medical device for determining user-specific treatment parameter values for a multi-channel transcutaneous neurostimulation treatment to be applied at multiple locations on a user's scalp using the medical device, the actuation method comprising: a. for the medical device, setting a first set of treatment parameter values for a first electrode array adapted to engage a first portion of the user's scalp for administering electrical pulses to the first portion according to a first dependency comprising a first direct relationship between at least one parameter value in the first set of treatment parameter values and a corresponding at least one parameter value in a set of user-specific sensation threshold parameter values; and b. for the medical device, setting a second set of treatment parameter values for a second electrode array adapted to engage a second portion of the user's scalp for administering electrical pulses to the second portion according to a second dependency comprising a second direct relationship between at least one parameter value in the second set of treatment parameter values and at least one parameter value in the first set of treatment parameter values, wherein (i) the first portion of the scalp is anterior and the second portion of the scalp is posterior, or (ii) the first portion of the scalp is posterior and the second portion of the scalp is anterior.

2. The actuation method of claim 1, wherein each respective set of treatment parameter values comprises values for at least two of: i. a charge parameter having a value for a total charge over a given time period, wherein the given time period is an integer multiple of an inverse of a frequency of electrical pulses, ii. a current intensity parameter, and iii. a pulse duration parameter and a frequency parameter or an arithmetic combination of a pulse duration parameter and a frequency parameter.

3. The actuation method of claim 1, wherein the direct relationship is based in part on a relationship between respective electrode surface areas of the first electrode array and the second electrode array.

4. The actuation method of claim 1, wherein the second dependency is a linear relationship based on an empirical dependency.

5. The actuation method of claim 1, wherein according to the direct relationship, a charge parameter value in the second set of treatment parameter values is equal to a charge parameter value in the first set of treatment parameter values multiplied by B, wherein B is not less than 1.1 and not greater than 3.

8.

6. The actuation method of claim 1, wherein the transcutaneous neurostimulation treatment comprises forwardly applied electrical pulses targeting the trigeminal nerve and posteriorly applied electrical pulses targeting the occipital nerve.

7. The actuation method of claim 1, wherein values of the set of user-specific sensation threshold parameter values are based on first user input received during application of a series of electrical pulses to a single one of the first portion and the second portion of the user's scalp.

8. The actuation method of claim 1, wherein the first dependency is a linear relationship based on an empirical dependency.

9. The actuation method of any one of claims 1 to 8, wherein according to the first direct relationship, a charge parameter value in the first set of treatment parameter values is equal to a charge parameter value in the set of user-specific sensation threshold parameter values multiplied by A, where A is not less than 1.3 and not greater than 1.9.

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