Methods and devices for percutaneous nerve stimulation therapy

Abstract

A method for determining treatment parameter values ​​for a transcutaneous nerve stimulation therapy to be applied to a user's scalp comprises: setting a first treatment parameter value set for a first electrode array engaged with a first portion of the user's scalp to deliver electrical pulses according to a correlation that includes, for example, a direct relationship between at least one parameter value of a first treatment parameter value set and at least one corresponding parameter value of a user proprioceptive threshold parameter value set; and setting a second treatment parameter value set for a second electrode array engaged with a second portion of the user's scalp to deliver electrical pulses according to another correlation that includes another direct relationship between at least one parameter value of a second treatment parameter value set and the at least one parameter value of the first treatment parameter value set.

Description

Technical Field

[0001] Cross - reference to Related Applications This patent application claims the benefit of U.S. Provisional Patent Application No. 62 / 888,497, filed on August 18, 2019, which is incorporated herein by reference in its entirety.

[0002] The present invention relates to devices and methods for applying electrical stimulation to the head region, particularly to methods for setting, calibrating, and verifying the reliability of electrical parameters for treatments using electrical nerve stimulation, and to devices and software applications for facilitating such calibration.

Background Art

[0003] The present invention relates to devices and methods for applying electrical stimulation to the head region for nerve stimulation therapy. The disclosed methods and devices can be used for calibrating treatment parameters used in the stimulation of peripheral and cranial nerves, including calibration by the user of nerve stimulation therapy.

[0004] Peripheral and cranial nerves in the head region can be stimulated to treat various conditions such as chronic pain, migraine, tension - type headache, cluster headache, trigeminal neuralgia, occipital neuralgia, fibromyalgia, depression, post - traumatic stress disorder (PTSD), anxiety, stress, 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). Anatomical diagrams of peripheral and cranial nerves in the head region, such as the occipital and trigeminal nerves, and their projection diagrams to brainstem regions such as the locus coeruleus and nucleus raphe magnus, and to higher - order brain regions such as the thalamus and anterior cingulate cortex, can be advantageous when stimulating these nerves to treat such conditions.

[0005] For example, nerve stimulation of surface nerves in the head region, such as the occipital nerve branches, supraophthalmic nerve branches, supratrochlear nerve branches, zygomaticotemporal nerve branches, and auricular temporal nerve branches, can be applied invasively or non-invasively. Because it is difficult to transmit current through hair, stimulation of cranial nerves located beneath areas covered by hair, such as the occipital nerve (greater occipital nerve branches, lesser occipital nerve branches, and third occipital nerve branch), is generally performed using implantable or transcutaneous nerve stimulators. Such devices include electrodes that are inserted under the scalp and bypass the high impedance barrier formed by hair and scalp. However, implantable nerve stimulation is still invasive and a costly procedure with a high rate of complications, including infection, bleeding, or subcutaneous fluid accumulation, as well as hardware-related malfunctions such as migration or damage of the implanted wires and failure of the pulse generator. Non-invasive techniques, such as percutaneous stimulation of cranial nerves including occipital nerve branches, have the potential to achieve similar clinical utility to implantable stimulators without the risks and costs associated with invasive procedures.

[0006] Transcutaneous nerve stimulation therapy ensures that it is performed by the subject of such therapy in their own comfortable personal environment. However, it should be noted that transcutaneous therapy may still require user-specific, personalized settings of certain treatment parameters, such as the current intensity and pulse duration faced during treatment. Also, electrical stimulation directed to various parts of the user's head may require different treatment parameters for effective stimulation of the various nerves involved. The treatment parameters are optimally set and calibrated to take into account both the efficacy of the therapy and the comfort of the user receiving the treatment.

[0007] Therefore, there is a recognized need for devices and methods for the effective setting and calibration of neurostimulation parameters that can be effectively operated by both healthcare professionals and users of the treatment, and having them is highly advantageous.

[0008] Systems, apparatus, and methods for supplying neurostimulation therapy are disclosed in Applicant's Patents US 9,433,774 and US 9,872,979, and in Applicant's concurrently pending U.S. Patent Application No. 15 / 510,067, filed on 16 September 2015 and published as U.S. 20170296121, in application No. 16 / 070,563, filed on 26 January 2017 and published as U.S. 20190022372, and in application No. 16 / 093,094, filed on 9 April 2017 and published as U.S. 20190117976, each of which is incorporated herein by reference in its entirety. [Overview of the Initiative]

[0009] According to the embodiment, a method is disclosed for determining user-specific therapeutic parameter values ​​for multi-channel transcutaneous nerve stimulation therapy applied to multiple locations on the user's scalp. The method comprises (a) setting a first therapeutic parameter value set relating to a first electrode array engaged with a first portion of the user's scalp to administer electrical pulses, according to a first correlation including a first direct relationship between at least one parameter value of a first therapeutic parameter value set and the corresponding at least one parameter value of a user-specific sensory threshold parameter value set; and (b) setting a second therapeutic parameter value set relating to a second electrode array engaged with a second portion of the user's scalp to administer electrical pulses, according to a second correlation including a second direct relationship between at least one parameter value of a second therapeutic parameter value set and the at least one parameter value of the first therapeutic parameter value set.

[0010] In some embodiments, each set of therapeutic parameter values ​​may include (i) a charge parameter having a total charge value over a given period that is an integer multiple of the reciprocal of the electrical pulse frequency, (ii) a current intensity parameter, and (iii) at least two values ​​of a pulse duration parameter and a frequency parameter, or an arithmetic combination thereof.

[0011] In some embodiments, (i) the first portion of the scalp is the anterior portion and the second portion of the scalp is the posterior portion, or (ii) the first portion of the scalp is the posterior portion and the second portion of the scalp is the anterior portion.

[0012] In some embodiments, the second direct relationship may be based in part on the relationship between the respective electrode surface areas of the first and second electrode arrays.

[0013] In some embodiments, the values ​​of the user-proprioceptive threshold parameter value set are based on a first user input received while applying an electrical pulse train to one of the first and second portions of the user's scalp.

[0014] In some embodiments, the first and second correlations may be linear relationships based on their respective empirical correlations.

[0015] In some embodiments, according to the first direct relationship described above, the charge parameter value of the first set of treatment parameter values ​​is equal to the number obtained by multiplying the charge parameter value of the set of user-proprioceptive threshold parameter values ​​by A, where A may be between 1.1 and 3.2. In some embodiments, A may be between 1.4 and 2.0. In some embodiments, A may be between 1.3 and 1.9.

[0016] In some embodiments, according to the second direct relationship described above, the charge parameter value of the second set of treatment parameter values ​​is equal to the number obtained by multiplying the charge parameter value of the first set of treatment parameter values ​​by B, where B may be between 1.1 and 3.8. In some embodiments, B may be between 1.4 and 3.4. In some embodiments, B may be between 1.8 and 3.0.

[0017] In some embodiments, the method may further comprise calibrating a treatment threshold, which includes (i) activating a transcutaneous nerve stimulation calibration session using the first and second sets of treatment parameter values ​​as the respective treatment parameter values ​​applied to the first and second portions of the user's scalp; (ii) receiving a user calibration input during the calibration session; and (iii) changing at least one value of the first and second sets of treatment parameter values ​​in response to receiving the user calibration input.

[0018] In some embodiments, changing the value of at least one of the first and second sets of treatment parameter values ​​may include modifying at least one treatment parameter value other than current intensity.

[0019] In some embodiments, the above modifications may be restricted so that the charge parameter values ​​are limited to a predetermined range. In some embodiments, the above modifications may be restricted so that the number of modifications per calibration session is limited to a predetermined number of modifications. In some embodiments, the above modifications may be limited to a predetermined time interval. In some embodiments, the time from receiving the user calibration input to completing the modifications may be less than 1 second. In some embodiments, the time from receiving the user calibration input to completing the modifications may be less than 500 msec. In some embodiments, the time from receiving the user calibration input to completing the modifications may be less than 200 msec.

[0020] In some embodiments, transcutaneous nerve stimulation therapy may include an electrical pulse applied to the anterior region targeting the trigeminal nerve and an electrical pulse applied to the posterior region targeting the occipital nerve.

[0021] In some embodiments, the electrical pulse treatment may be performed by a device including electrodes that is attached to the user's head, and the device comprises a headset.

[0022] In some embodiments, the first user input and at least one of the user calibration inputs may be received via a computer software program running on an external user operating device that is in electronic communication with the headset. In some such embodiments, (i) the headset may have a user interface mounted on the headset, and / or (b) the first user input and at least one of the user calibration inputs may be received via the user interface on the headset.

[0023] According to the embodiment, a method is disclosed for determining user-specific therapeutic parameter values ​​for multi-channel transcutaneous nerve stimulation therapy applied to multiple locations on the user's scalp. The method comprises (a) setting a first set of therapeutic parameter values ​​for a first electrode array engaged with a first portion of the user's scalp to administer electrical pulses, and (b) setting a second set of therapeutic parameter values ​​for a second electrode array engaged with a second portion of the user's scalp to administer electrical pulses, according to a second correlation including a direct relationship between at least one parameter value of a second set of therapeutic parameter values ​​and the at least one parameter value of the first set of therapeutic parameter values.

[0024] In some embodiments, each set of therapeutic parameter values ​​may include (i) a charge parameter having a total charge value over a given period that is an integer multiple of the reciprocal of the electrical pulse frequency, (ii) a current intensity parameter, and (iii) at least two values ​​of a pulse duration parameter and a frequency parameter, or an arithmetic combination thereof.

[0025] In some embodiments, (i) the first portion of the scalp may be the anterior portion and the second portion of the scalp may be the posterior portion, or (ii) the first portion of the scalp may be the posterior portion and the second portion of the scalp may be the anterior portion.

[0026] In some embodiments, the direct relationship may be based in part on the relationship between the electrode surface areas of the first and second electrode arrays.

[0027] In some embodiments, the correlation relationship may be a linear relationship based on an empirical correlation relationship.

[0028] In some embodiments, according to the direct relationship, the charge parameter value of the second set of treatment parameter values is equal to the charge parameter value of the first set of treatment parameter values multiplied by B, and B may be 1.1 or more and 3.8 or less. In some embodiments, B may be 1.4 or more and 3.4 or less. In some embodiments, B may be 1.8 or more and 3.0 or less.

[0029] In some embodiments, the transcutaneous nerve stimulation treatment may include an electrical pulse applied to the front targeting the trigeminal nerve and an electrical pulse applied to the back targeting the occipital nerve.

[0030] In some embodiments, the application of the electrical pulse may be performed by a device including electrodes worn on the user's head, and the device includes a headset.

[0031] According to the embodiment, a method is disclosed for determining user-specific therapeutic parameters for multi-channel transcutaneous nerve stimulation therapy applied to multiple locations on the user's scalp. The method includes (a) providing the user's scalp with a first electrical pulse train having electrical parameter values ​​that increase at a first rate of increase, each of which electrical parameter values ​​comprises at least one charge parameter value and a current intensity value; (b) defining a set of multiple electrical parameter values ​​as a sensory threshold parameter value set when the first user input is received, in response to receiving a first user input indicating that the user has felt skin sensation in connection with the application of the first electrical pulse train; and (c) providing the user's scalp with a reliability confirmation electrical pulse train having electrical parameter values ​​that increase at a second rate of increase, each of which electrical parameter values ​​comprises a charge parameter Providing at least one of lamometer values ​​and current intensity values, the reliability confirmation sequence is configured such that (i) each electrical parameter value pauses before reaching the sensory threshold parameter value, and (ii) resumes after the pause; (d) after the pause, the reliability of the sensory threshold parameter value is confirmed in response to receiving a second user input indicating that the user felt skin sensation in connection with the application of the reliability confirmation electrical pulse sequence at each electrical parameter value within a predetermined range of values ​​near the sensory threshold parameter value; and (e) multichannel transcutaneous nerve stimulation therapy is applied using a therapy parameter value based on the sensory threshold parameter value whose reliability has been confirmed.

[0032] In some embodiments, the therapeutic parameter values ​​may include at least two of the following: (i) a charge parameter having a total charge value over a given period that 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.

[0033] In some embodiments, the first electrical pulse train may be applied to a first portion of the user's scalp, and the reliability-checking electrical pulse train may be applied to a second portion of the scalp different from the first portion. In some embodiments, both the first electrical pulse train and the reliability-checking electrical pulse train may be applied to the first portion of the user's scalp.

[0034] In some embodiments, (i) the first portion of the scalp may be the anterior portion and the second portion of the scalp may be the posterior portion, or (ii) the first portion of the scalp may be the posterior portion and the second portion of the scalp may be the anterior portion.

[0035] In some embodiments, transcutaneous nerve stimulation therapy may include an electrical pulse applied to the anterior region targeting the trigeminal nerve and an electrical pulse applied to the posterior region targeting the occipital nerve.

[0036] In some embodiments, providing the first electrical pulse train and providing the reliability-verifying electrical pulse train may be done by a device including electrodes that is worn on the user's head, the device comprising a headset.

[0037] In some embodiments, at least one of the first user input and the second input may be received via a computer software program running on an external user-operated device that is in electronic communication with the headset.

[0038] In some embodiments, (i) the headset may include a user interface on the headset that is attached to the headset, and (ii) at least one of the first user input and the second user input may be received via the user interface on the headset.

[0039] According to one embodiment, a non-temporary computer-readable storage medium is disclosed which, when executed by one or more processors, stores program instructions that cause one or more processors to perform any of the steps of the methods disclosed herein.

[0040] According to some embodiments, a user input device for use during transcutaneous nerve stimulation therapy comprises a user interface, one or more processors, and a non-temporary computer-readable storage medium storing program instructions that, when executed by the 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 comprising a headset and a plurality of electrodes configured to supply electrical pulses to the user's scalp.

[0041] The present invention is described herein merely by reference with reference to the accompanying drawings. While the drawings are given particular detail here, it is emphasized that the details shown are provided solely as examples to illustrate preferred embodiments of the invention and are presented in a manner that is considered to be the most convenient and easily understandable explanation of the principles and conceptual aspects of the invention. In this regard, no attempt has been made to describe the structural details of the invention in more detail than necessary for a basic understanding of the invention, and the description is presented with the drawings to make it clear to those skilled in the art how some forms of the invention can actually be embodied. Throughout the drawings, similar reference numerals are used to indicate similar functions, though not necessarily identical elements. [Brief explanation of the drawing]

[0042] [Figure 1] This is a schematic block diagram of an embodiment of an inventive system for nerve stimulation according to the teachings described herein. [Figure 2]A schematic perspective view is provided of an inventive, wearable headset adapted for communication with a remote control unit, a mobile phone, and a computer. [Figure 3] This is a schematic perspective view of an inventive system embodiment of the teaching headset described herein, as shown in Figure 1A. [Figure 4-13] A flowchart of a method component comprising method steps for defining, setting, testing, verifying, calibrating, and applying parameters for transcutaneous nerve stimulation, according to an embodiment of the present invention, is shown. [Figure 14-19] Figures 4-13 show flowcharts of a method including various method steps and method components according to an embodiment of the present invention. [Modes for carrying out the invention]

[0043] A system and method are described for applying electrical stimulation to the head region for the stimulation of peripheral and / or cranial nerves, or transcranial stimulation of brain regions, while also sensing bodily parameters, monitoring tissue, and adapting the electrical stimulation signal to the user's characteristics and changes over time. This system and method ensures effective electrical stimulation while avoiding damage to scalp tissue and user discomfort, and operates in a safe and robust manner.

[0044] This inventive method can be applied using a head-mounted structure that functions as a platform for applying electrical stimulation according to the method of the present invention to treat various conditions such as migraines, tension headaches, cluster headaches, 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.

[0045] In this specification, the term "user" means a person who is receiving or intending to receive transcutaneous stimulation therapy using electrical stimulation. Electrical stimulation of pure sensory nerves produces a spread of parasensory effects along the nerve distribution in response to the applied electrical stimulation.

[0046] This disclosure addresses “cutaneous sensations” that a user may experience in response to the application of transcutaneous electronerve stimulation, which may include one or more of stinging, puncturing, cold, inflammation, or numbness, and such cutaneous sensations may correspond to the perception of paresthesia.

[0047] The minimum threshold at which a user perceives or recognizes such a tactile sensation or paresthesia is called the "sensory threshold," and the sensory threshold may be specific to the user at a given time under given environmental and under given conditions.

[0048] Herein, Figure 1 is a schematic block diagram of a typical system embodiment for nerve stimulation according to the teaching embodiment described herein.

[0049] As shown, the system 101 for nerve stimulation may include at least two stimulating electrodes 102, and in some embodiments, may further include at least two sensing electrodes 104, both of which are functionally associated with the electronic circuit 106. The stimulating electrodes 102 are adapted to engage with the user's scalp to conduct an electric current, as described later. 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 the user's body part, such as electroencephalography (EEG), skin conduction response (SCR), impedance plethysmography (IPG), or electromyography (EMG).

[0050] As described herein, the system 101, and in particular the electronic circuit 106, can be adapted to deliver transcranial electrical stimulation using appropriate methods such as transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial random noise stimulation (tRNS). The terms “transcutaneous” and “transcranial” can be used synonymously as long as the treatment or electrical stimulation procedure described herein relates to the user’s head or scalp. The term “scalp” as used herein should be understood in its broadest sense, and in particular should be understood to include the skin of the forehead, i.e., the user’s “face” portion above the user’s eyes.

[0051] As shown, the electronic circuit 106 may include a microcontroller 108, a high-voltage circuit 110, a stimulation circuit 112, an internal power supply 114, a radio frequency (RF) transceiver 116, an analog signal processing circuit 118, a rechargeable battery 120 electrically associated with a charging circuit 122, a sensor array 124 including one or more accelerometers 126, a temperature sensor 128, a pressure sensor 130, and a humidity sensor 132, and any one or more user interfaces 134.

[0052] In some embodiments, the electronic circuit 106 may be electrically connected to and powered by a rechargeable battery 120 electrically connected to an internal power supply 114. In some embodiments, the internal power supply 114 powers a high-voltage circuit 110, which is electrically connected to a stimulation circuit 112. The charging circuit 122 is electrically connected to the rechargeable battery 120 and may interface with an external power source, such as a charger 140. The high-voltage circuit 110 provides the stimulation circuit 112 with a current having a voltage in the range of 1 to 150V. In some embodiments, the rechargeable battery 120 may be replaced with a disposable battery configured to operate at the same voltage and current range.

[0053] In some embodiments, 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 nerve tissue via the stimulation electrode 102.

[0054] The stimulation circuit 112 may be configured to generate biphasic charge-balanced electrical pulses, monophasic electrical pulses, and / or DC stimulation.

[0055] According to additional features of the embodiments described, the stimulation circuit 112 may be configured to generate electrical stimulation within an intensity range of 0-60mA, 0-40mA, 0-20mA, or 0-15mA.

[0056] According to additional features of the embodiments described, the stimulation circuit 112 may be configured to generate stimulation pulses having durations of 10-1000 μsec, 50-600 μsec, and 100-500 μsec.

[0057] According to additional features of the embodiments described, the stimulation circuit 112 may be configured to generate stimulation pulses at frequencies of 1-20,000 Hz, 1-10,000 Hz, 1-500 Hz, 10-300 Hz, 10-250 Hz, 20-180 Hz, 30-180 Hz, or 40-100 Hz.

[0058] In some embodiments, the electronic circuit 106 may include two or more high-voltage circuits (not shown) similar to circuit 112, each high-voltage circuit providing currents of voltages between 1 and 150V, 1 and 120V, and 1 and 100V to at least two of the stimulating electrodes 102. In some embodiments, the 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.

[0059] In some embodiments, the electronic circuit 106 also includes a feedback and measurement circuit 142 that collects voltage or current level information from the stimulating electrode 102 and provides the collected information to the microcontroller 108. The microcontroller 108 uses the provided feedback to monitor and control the voltage and current levels at the stimulating electrode 102 via the stimulating circuit 112. In some embodiments, the microcontroller 108 may warn the user in emergencies or system malfunctions, for example, by providing audible or tactile indications, or by stopping the supply of current for stimulation.

[0060] In some embodiments, the microcontroller 108 may instruct the stimulation circuit 112 to output current in various patterns and / or over various periods of time, 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.

[0061] In some embodiments, the microcontroller 108 may instruct the stimulation circuit 112 to provide output signals having different patterns for each of a plurality of working electrode pairs. For example, the stimulation circuit 112 may stimulate one electrode pair with a pulse frequency of 50 Hz and a phase duration of 300 μsec, and stimulate the other electrode pair 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 electrode pair, activate a combination of electrodes, and / or activate several electrodes simultaneously, continuously, or alternately.

[0062] In some embodiments, some electrodes 102 may provide an AC signal as an output, while other electrodes 102 may provide a DC output. In some embodiments, at least two electrodes 102 may alternate between providing AC and DC currents as outputs.

[0063] In some embodiments, during direct current stimulation in which excitation of a particular region of the brain is determined based on the polarity of an electrode located above that region of the brain, at least one electrode 102 may be assigned by a microcontroller 108 as an anode, i.e., a positively charged electrode, and at least one other electrode 102 may be assigned as a cathode, i.e., a load electrode.

[0064] In some embodiments, the stimulation patterns determined or assigned by the microcontroller 108, as well as the feedback data received from the electrodes 102 and / or sensing electrodes 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 patterns may be used to generate personalized neurostimulation therapy protocols.

[0065] In some embodiments, the electronic circuit 106 may be configured to receive analog signal inputs from one or more sensors, such as a sensing electrode 104, including, for example, an electroencephalogram (EEG), skin conduction response (SCR), impedance plethysmography (IPG), electromyography (EMG), or other biosignals, which may represent the impedance of the tissue receiving the nerve stimulation signal, the charge supplied to the tissue, and so on. The analog signal input received from the sensing electrode 104 may be processed by an analog signal processing circuit 118 and then transferred to the microcontroller 108. In some embodiments, the electronic circuit 106 may be configured to receive digital, analog, or other inputs from additional sensors adapted to sense the vicinity of or characteristics of a user. In some embodiments, as described later, one or more stimulation parameters may be modified by the microcontroller 108 based on inputs received from one or more of the additional sensors.

[0066] In some embodiments, the accelerometer 126, or any other suitable attitude sensor, may be configured to sense the angular position of the user's head or the device embodying the system 101 (particularly the part that engages with the user's head), so that the microcontroller 108 may identify changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulating electrodes 102. For example, a change in the user's position may result in a change in the pressure applied to the electrodes, so that, as described later, the degree to which the electrodes approach the user's skin changes, resulting in a change in impedance within the system and requiring adaptation of the pulses applied to the tissue through the electrodes. In some embodiments, a vibrating structure microelectromechanical system (MEMS) gyroscope 127 may be configured to provide angular motion information in addition to the motion and attitude information provided by the accelerometer 126.

[0067] In some embodiments, the temperature sensor 128 may be configured to sense the temperature near the system 101 or the stimulating electrode 102, thereby enabling the microcontroller 108 to identify changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulating electrode 102. For example, an increase in temperature near the user or electrode 102 may result in rapid dehydration of the electrode or the conductive material coated on the electrode, so that the impedance in the system increases, as will be discussed later, and the pulses applied to the tissue via the electrode need to be adapted.

[0068] In some embodiments, the pressure sensor 130 may be configured to sense pressure applied to the user's head in the vicinity of the electrode 102 or pressure applied directly to the electrode 102, thereby enabling the microcontroller 108 to identify changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulating electrode 102. For example, an increase in the magnitude of the pressure applied to the electrode 102 pushing it toward the user's scalp is expected to reduce the distance between the electrode and the scalp, and possibly between the electrode and the target nerve, thus reducing the impedance in the system and requiring or making it possible to adapt the pulses applied to the tissue via the electrode.

[0069] In some embodiments, the humidity sensor 132 may be configured to sense humidity or moisture levels in the vicinity of the system 101 or the stimulating electrode 102, thereby enabling the microcontroller 108 to identify changes in user and / or system conditions and adjust or adapt the pulses provided by the stimulating electrode 102.

[0070] In some embodiments, the user interface 134 may be configured to receive indications from the user of sensations the user is experiencing, such as indications of pain, indications of discomfort, or indications of decreased or absent paresthesia (cutaneous sensation). Based on such user indications regarding changes in user-perceived sensations, the microcontroller 108 may be able to adjust or adapt the pulses provided by the stimulating electrodes 102, or evaluate user calibration of sensation and therapeutic thresholds and thresholds, as described elsewhere in this disclosure.

[0071] In some embodiments, the RF transceiver 116 may enable the microcontroller 108 to communicate with an interface of an external device 150, such as a mobile phone, tablet, computer, or cloud-based database, using radio frequencies. The RF transceiver 116 may transmit digital information to and receive digital information from the microcontroller 108, for example, for the personalization of neurostimulation therapy provided by the system 101. The RF transceiver 116 may be operable 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.

[0072] The interface of device 150 may include a software application that may be downloadable from an easily accessible resource, such as the internet. The interface may provide the user with indications of the status of system 101, for example, using a display, including information on the active stimulation channel, stimulation intensity, active program, treatment time, battery status, and RF communication status, as well as various warnings, such as warnings regarding electrode contact quality and proper or improper system alignment to the head. In addition, the interface may provide the user with usage logs and / or reports, for example, using a display, including information on daily stimulation time, stimulation parameters used during stimulation, and treatment programs 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.

[0073] In some embodiments, the system may be remotely controlled via an interface to an external device 150. For example, the external interface may allow the user to activate or deactivate the system, start or pause stimulation, adjust stimulation intensity for one or more channels, and select a treatment program. In some embodiments, information collected by the microprocessor 108 may be transmitted via the external interface to a remote location, such as a cloud-based portal, where the information may be stored, analyzed, and / or monitored.

[0074] Here, we refer to Figure 2A, which shows some components of the neurostimulation therapy system. The headset 100 is worn on the user's head 90. In some embodiments, the headset 100 may be configured to wirelessly communicate with one or more external devices 150 using communication channels 80. Any communication channel 80 may use any combination of direct device-to-device communication (e.g., via Wi-Fi, Bluetooth, IR, or any other wireless device-to-device communication or wired communication) and indirect communication (e.g., routed via a server and / or router and / or other local network devices and internet devices).

[0075] An example of an external device 150 is a remote control device 560 that can be used by the user to send commands and other inputs to the headset 100. The remote control device 560 may present various visual and auditory indications for the user regarding the status of the headset 100. Additionally or alternatively, the headset 100 may be configured to communicate wirelessly with a mobile phone 570. The mobile phone interface may be used to present various data wirelessly transmitted by the headset 100, such as visual and auditory indications regarding the status of the headset 100 and usage logs. As shown in the block diagram of a typical handheld device, such as the mobile phone 570 in Figure 2B, the mobile phone 570 includes a non-temporary computer-readable storage medium 50 in which program instructions 51 are stored for execution by one or more processors 54 of the mobile phone 570. The program instructions 51 may cause the mobile phone 570 and / or the headset 100 to control a neurostimulation therapy session, including, for example, determining therapy protocol parameters before a therapy session, capturing user commands and other inputs, and / or determining therapy protocol parameters. The mobile phone 570 in Figure 2B further includes a communication configuration 53 for communicating with the headset 100 (in particular) and a user interface 52 which may include a touchscreen. The user interface 52 may be used for any form of interaction between the user and a software program comprising program instructions 51, and the user interface 52 may be used to present various data wirelessly transmitted by the headset 100, such as visual and auditory indications and usage logs regarding the status of the headset 100.

[0076] Referring to Figure 2A, the headset 100 may be configured to communicate wirelessly with the laptop / PC 580, either as an addition or as an alternative. Similar to the mobile phone 570, the laptop / PC 580 may be configured to have a non-temporary computer-readable storage medium in which program instructions 51 are stored.

[0077] Any one or more of the “user input devices” 150 shown in Figure 2A (a mobile phone 570, a remote control device 560, and a PC / laptop 580) may be used interchangeably in carrying out the methods disclosed herein. A headset 100 suitable for carrying out the methods disclosed herein includes any of the headsets disclosed in Applicant’s US Patents No. 9,433,774 and US No. 9,872,979, and Applicant’s concurrently pending US Patent Application No. 15 / 510,067, filed on 16 September 2015 and published as US20170296121, and No. 16 / 070,563, filed on 26 January 2017 and published as US20190022372, and No. 16 / 093,094, filed on 9 April 2017 and published as US20190117976.

[0078] Herein, we refer to Figure 3, a schematic perspective view of a non-limiting and typical embodiment of a headset 100 implementing the system 101 of Figure 1. As shown, the headset 100 may be configured to include a front member 162 connected to a pair of flexible arm members 164, each of which may also be called intermediate members, terminating at a rear member 166. The front member 162, the flexible arm members 164, and the rear member 166 together form the headset body. In some embodiments, the electrode system 172 may include an anterior electrode adapted to be located in the supraorbital region of the head covering the portion of the trigeminal nerve to stimulate the trigeminal nerve branches, or an electrode suitable for transcranial stimulation of the frontal and anterior frontal lobe 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 covering the portion of the occipital nerve to stimulate the occipital nerve branches, or an electrode suitable for transcranial stimulation of the occipital region of the brain.

[0079] As can be understood, the headset 100 may include additional electrodes having a similar structure and / or function to electrode systems 172 and 174. As can be further understood, electrode systems 172 and / or 174 may be omitted or moved to other positions on the headset 100 to be suitable for stimulating specific nerves or sets of nerves or specific brain regions. For example, electrode system 174 may be moved along a flexible arm member 164. As another example, the headset 100 may include only one pair of electrode systems located on the arm member 164, and these electrodes may be configured to be located under the hair when the headset is worn, and electrode systems 172 and 174 may be omitted. In some embodiments, electrodes may be directed to stimulate nerves located in the lateral regions of the brain as an addition to or alternative to stimulating anterior and / or posterior nerves.

[0080] The front member 162 may be configured to include an electronic circuit 176 similar to the electronic circuit 106 in Figure 1, which may be configured to be electrically coupled by conductive wires (not shown) to a power source 177, such as a battery similar to the battery 120 in Figure 1, and to electrode systems 172 and 174. In some embodiments, at least a portion of the conductive wires extends to the rear electrode system 174 via an arm member 164.

[0081] In some embodiments, the electronic circuit 176 and / or battery 177 may be located outside the headset 100 and / or communicate remotely with the headset 100.

[0082] As described above with reference to Figure 1, the electronic circuit 176 may include a stimulation circuit, a microprocessor, a charging circuit, and a user interface.

[0083] In some embodiments, the headset 100 may be configured to transfer current from an external stimulator to electrode systems 172 and / or 174 by connecting to external electronic circuits and / or stimulator circuits. In some embodiments, the headset 100 may be configured to connect to at least one external electrode which may be located in various areas of the body. In some embodiments, the headset 100 may be configured to connect to external electronic circuits and a processor to transfer signals from sensors located in the headset 100 to an external processor.

[0084] In some embodiments, the battery 177 may be located within the front member 162, and according to certain embodiments, it can be recharged by plugging a charger into a charging port 178 located in the rear member 162.

[0085] The front member 162 may also be configured to include a user control device and interface 180 on its outer surface, which may be similar to the user interface 134 in Figure 1. However, in some embodiments, other parts of the headset 100, such as the rear member 166 or arm 164, may be configured to include the user interface 180. Some of the functions of the onboard (i.e., permanently or detachably mounted or installed) user interfaces 180, 134 may overlap with the functions of the user interface 52 of the external device 150, for example, enabling the reception of user input to control neurostimulation therapy or to set one or more therapy-related parameters. In some embodiments, the user may use both the user interface 180 on the headset and the user interface 52 on the device, but in other embodiments, only one of the two user interfaces 180, 52 is available to the user.

[0086] The electronic circuit 176 and the user interface 180 may be configured to control and / or activate electrodes included in the headset 100. In some embodiments, the user interface 180 is configured to control and / or activate at least two, and in some embodiments, more than two, electrode pairs. Thus, in some embodiments, the stimulation circuit and / or user interface 180 is configured to enable the activation of specific electrodes or electrodes of a particular pair or channel, as well as the adjustment of the intensity of the current supplied by the activated electrodes or other stimulation parameters of the activated electrodes, and the provision of user indications such as user indications of pain, user indications of discomfort, or user indications of increasing or decreasing paresthesia. In some embodiments, any subset of electrodes may be activated simultaneously, and in some embodiments, a particular subset is predefined, for example, during the manufacture of the electronic circuit 176. In some such embodiments, the user interface 180 enables control of activated electrode subsets as well as control of specific electrodes or channels.

[0087] In some embodiments, the user control unit and interface 180 includes a pair of front intensity buttons 181a and 181b for increasing and decreasing the intensity of the stimulation provided by the front electrode system 172, and a pair of rear intensity buttons 182a and 182b for increasing and decreasing the intensity of the stimulation provided by the rear electrode system 174, respectively. As understood, the user control unit and interface 180 may include similar intensity buttons for each electrode included in the headset 100.

[0088] The user control unit and interface 180 may further include a mode change button 184 for activating and deactivating the electronic circuit 176 and for changing the operating mode of the headset 100. For example, the headset 100 may have several pre-set operating modes, such as sleep mode, maintenance mode, and treatment mode, and these modes can be switched by repeatedly operating the button 184, in addition to turning the headset on and off.

[0089] For example, a user indication button that enables the user to provide a user indication indicating a reduction in pain, discomfort, or paresthesia may form part of the user control device and interface 180 and may be located on the outer surface of the front member 162.

[0090] In some embodiments, the user control device and interface 180 may further include audio elements (not shown), such as a speaker or buzzer, to provide the user with audible indications of the use of the headset 180, such as activation of the headset, shutdown of the headset, pressing of a button on the interface 180, or indication of a change in the stimulation mode.

[0091] As described above, the electronic circuit and user interface are configured to control and / or activate electrodes included in the headset 100. In some embodiments, the user interface is configured to control and / or activate at least two, and in some embodiments, more than two, electrode pairs. Thus, in some embodiments, the stimulation circuit and / or user interface are configured to allow activation of specific electrodes or electrodes of a particular pair or channel, as well as adjustment of the intensity of the current supplied by the activated electrodes or other stimulation parameters of the activated electrodes. In some embodiments, any subset of electrodes may be activated simultaneously, and in some embodiments, a particular subset is predefined, for example, during the manufacturing of the electronic circuit. In some such embodiments, the user interface allows control not only of specific electrodes or channels, but also of activated electrode subsets.

[0092] In some embodiments, the electronic circuit 176 includes a transceiver 196 similar to the transceiver 116 in Figure 1, which is configured to communicate remotely with an external device 150.

[0093] According to embodiments of the present invention, a method for setting therapeutic parameters for a nerve stimulation therapy session may include determining a sensory threshold based on a train of 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 therapeutic threshold (recommended initial parameter) may be set based on the sensory threshold. A second therapeutic threshold may be set based on the first therapeutic threshold. The setting of the second therapeutic threshold based on the first therapeutic threshold may be based on a direct relationship between the two, for example, an empirically derived direct relationship. The sensory threshold may be a therapeutic parameter or a plurality of therapeutic parameters at which the user indicates feeling a paresthesia (or, more generally, cutaneous sensation) associated with a train of electrical stimulation pulses provided with monotonically increasing current intensity.

[0094] As used herein, the term "therapeutic parameter" may mean any (or all) of the following: • Charge parameter. The charge parameter may have the value of the total charge over a given period, which is generally an integer multiple of the reciprocal of the electrical pulse frequency (which may be called the pulse "period"). As a typical example, if the pulse frequency is 50 Hz, the reciprocal of the frequency is 20 milliseconds (msec), and the given period of choice may be 1 sec. For higher granular resolution, the given period may be as short as a single "period," in which case it may be 20 msec. The unit of the charge parameter may be coulombs per second (or smaller units such as millicoulombs), which can be calculated by averaging or integrating the supply current (in milliamperes) over a given period. • Current intensity parameters, such as the peak current, average current, or steady-state current of an electrical pulse. • Pulse duration parameters and frequency parameters, or their arithmetic combinations. Pulse duration, also called pulse width, is generally measured in microseconds (μsec). This can be parameterized along with the duration (reciprocal of the frequency) to derive, for example, the ratio of each period during which the pulse is applied. For example, a pulse duration (pulse width) of 50 μsec with a frequency of 50 Hz means that the pulse is applied for 0.5 msec, or 2.5%, of a 20 msec period.

[0095] It is desirable to use two or more of the above electrical parameters to characterize a pulse train. For example, current intensity and charge, or the ratio of current intensity to the reciprocal of pulse duration and frequency, and the ratio of charge to the reciprocal of pulse duration and frequency are three typical sets of electrical parameters that can be used to characterize a pulse train. As those skilled in the art will understand, any of the above sets can also be used to calculate other parameters, for example, if the average current intensity and charge per period of a pulse are known, the ratio of the time (of each period) that the pulse is applied can be calculated.

[0096] In some examples, current intensity is used herein to illustrate the use of electrical parameters in various embodiments, for example, the use of monotonically increasing current intensity in methods for setting, testing, verifying, or calibrating sensory thresholds. In such examples, the exemplary use of current intensity is not intended to be limiting, and other electrical parameters or sets of electrical parameters may be substituted for current intensity where applicable.

[0097] In a typical embodiment, the sensory threshold can be measured using electrical stimulation pulses generated by an electrode positioned anteriorly, for example, electrode 172 in Figure 3. In other embodiments, electrodes may be positioned laterally as an addition or alternative, which are not shown in Figure 3.

[0098] Accordingly, in such embodiments, the first therapeutic threshold may be calculated from the sensory threshold using a first empirically developed direct relationship with respect to pulses directed to the front of the treatment protocol. The second therapeutic threshold in such embodiments may be calculated from the first therapeutic threshold using a second empirically developed direct relationship with respect to pulses directed to the rear of the treatment protocol. In some other embodiments, the first therapeutic threshold may be with respect to pulses directed to the rear of the treatment protocol, and the second therapeutic threshold may be with respect to pulses directed to the front of the treatment protocol. In yet another embodiment, the first and second therapeutic thresholds may be with respect to pulses directed to the front and pulses directed to the sides, respectively, pulses directed to the front and pulses directed to the sides, pulses directed to the sides and pulses directed to the sides, or pulses directed to the sides on both sides of the user's head. The first and second direct relationships may be empirically derived relationships based on therapeutic thresholds known to be within an effective range having current intensity higher than the minimum required to produce significant paresthesia and lower than the threshold that causes pain or excessive discomfort to the user. Any of the steps described above may be performed using a head-mounted device including one of the headsets 100 described herein. According to a preferred embodiment, before a treatment session, the user can "calibrate" the initial treatment parameters, i.e., the first and second treatment thresholds set according to the above description, by increasing or decreasing the treatment parameters (e.g., current intensity or pulse frequency) based in particular on the user's comfort. Embodiments of this method may be performed by executing program instructions 51 stored in an external device 150, such as a mobile phone 570, the execution of the program instructions 51 being performed by one or more processors of the device 150, as described later in this disclosure.

[0099] Referring here to Figures 4–9, flowcharts and “components” of methods relating to defining and setting user-specific sensory and therapeutic thresholds, in particular, according to various embodiments of the present invention, are shown. As shown, each component, i.e., group of one or more method steps, is given a block designation (e.g., block A) to simplify the drawings that follow, which present various combinations of various method components. Each component includes a brief text description (e.g., block A (head device)) for easy and convenient identification in the flowcharts of Figures 14–19, where blocks are combined in various combinations. However, these brief text descriptions accompanying the block names are provided solely to enable easy understanding of Figures 14–19 and are not intended to delineate or limit the scope of the corresponding method steps and components. Any of the individual components may constitute a method according to the present invention, and any combination of components may together constitute a method according to the present invention, whether such a method is expressly and / or described herein.

[0100] Referring here to Figure 4, “Block A (Head Device)” comprises step S01, which includes attaching a device to the user’s head that has electrodes configured to provide electrical stimulation pulses of the type used in transcutaneous nerve stimulation therapy. In some embodiments, the device comprises electrodes and wires connecting the electrodes to a power source. In some embodiments, the device further comprises a control circuit. The device may further comprise elements for holding the electrodes in place, which come into contact with the user’s scalp, such as a headband or elastic band. In some embodiments, the device may be a headset, such as one of the headsets 100 described above in this disclosure. When the term headset is used hereafter, it should be understood that this term includes any device having electrodes and does not necessarily have some or all of the other accessories of a fully functional headset, such as the example of headset 100 in Figure 3. In some embodiments, block A additionally or alternatively comprises step S01a, which includes verifying that such a device is attached to the user’s head. For example, if the user has not yet attached the device, step S01 is performed first. In contrast, if the user has already attached the device, step S01a is performed first. Naturally, it is possible to perform both step S01 (where the user attaches the device) and step S01a (where the attachment of the device is confirmed). In some embodiments, confirmation is included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. In some such embodiments, confirmation may include receiving confirmation information from a sensor, such as a sensing electrode 104. In other such embodiments, confirmation may include receiving user input in the user interface 52 of the mobile device 570. Confirmation may further include requesting user input in the user interface 52 before receiving user input. As an addition or alternative, confirmation may include receiving user input via an onboard interface 180.

[0101] Block B (Definition of Sensory Thresholds) comprises a group of method steps for determining sensory thresholds for a specific user, as shown in Figure 5.

[0102] In step S05, a set of stimulating electrodes 102 provides a series of electrical stimulation pulses, and in some embodiments, the set of stimulating electrodes 102 includes a plurality of anteriorly positioned electrodes. The series preferably begins with weak pulses, i.e., pulses below a selected electrical parameter, such as a current intensity threshold or a “time-dependent charge threshold,” at which point the user experiences any skin sensation associated with the pulse. Thereafter, the pulses monotonically increase the selected electrical parameter(s) as the series progresses. In some embodiments, other parameters of the pulse (e.g., pulse width, phase width, and frequency) remain constant.

[0103] Step S06 comprises receiving user input indicating that the user experienced a cutaneous sensation associated with the pulse train, such as a paresthesia. Alternative step S06' comprises receiving user input indicating that the user experienced a cutaneous sensation associated with the pulse train during an electrical stimulation pulse train in which the current intensity or charge increases over time, applied by a plurality of stimulating electrodes 102 to a specific area or multiple areas (e.g., anterior area) of the user's scalp. Step S06' may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. The user input of step S06 or step S06' is preferably received via the user interface 52 and / or onboard interface 180 of the mobile device 570.

[0104] However, where reference numbers used in this disclosure, such as S06', include an apostrophe after the number, this indicates an alternative version of a step, such as S06, which is intended to be included in a program instruction executed by one or more processors in a user input device, such as a mobile phone. In each example, the technical concept is the same with respect to each of the corresponding steps in pairs, such as S06 and S06'.

[0105] In response to receiving the first user input in step S06 or S06', a sensory threshold is defined in step S07, where the sensory threshold for any electrical parameter or set of electrical parameters is equal to the respective parameter value at the time the user input was received. That is, the sensory threshold corresponds to the electrical parameter in which the user experiences a significant cutaneous sensation (e.g., paresthesia) from the electrical stimulation pulse train.

[0106] Referring to Figure 6, block C (setting the first therapeutic threshold) comprises step S08, which includes setting the first therapeutic threshold based on a relationship between the first therapeutic threshold and the sensory threshold. In a preferred embodiment, this relationship is a direct relationship derived from empirical data. The first therapeutic threshold may be a therapeutic threshold for electrical stimulation pulses provided by a specific set of electrodes directed to a specific area or set of areas of the scalp, for example, electrode 172. In some embodiments, the first therapeutic threshold relates to anteriorly positioned electrode 172 that generates electrical stimulation pulses directed to anterior areas (or sets of areas) of the scalp, including, for example, the forehead. The therapeutic threshold may comprise a value or range of current intensity considered to provide effective transcutaneous nerve stimulation therapy. For example, the therapeutic threshold may be determined to be above a minimum value for paresthesia perceived by the user and below a maximum value for pain and / or discomfort perceived by the user. In some embodiments, the value for the therapeutic threshold is determined empirically by testing the user against the above minimum and maximum values. Example 1

[0107] In this example, the direct relationship between the first therapeutic threshold and the sensory threshold was empirically established using a sample group consisting of 24 users of headset 100 for transcutaneous nerve stimulation. The following table summarizes the sensory threshold (Tto) in milliamperes (mA), the first therapeutic threshold (Tt) in mA, and the Tt to Tto ratio for each user, as defined according to the teachings of step S07. [Table 1]

[0108] Based on the results for 24 users, the Tt to Tto ratio has a minimum value of 1.3, a maximum value of 2.8, and an average value of 1.7.

[0109] The first treatment threshold in step S08 may be calculated by multiplying the sensory threshold defined for the user by a multiplier A based on the relationship between Tt and Tto shown in empirical data. The empirical data-based multiplier A may be set somewhere within a range that encompasses all or most of the preferred treatment thresholds for each user. For example, A may be in the range of 1.0 to 3.2, and the preferred treatment thresholds for all 24 users in Example 1 fall within this range. Alternatively, A may be set somewhere within the range of 1.3 to 2.8, and again, the preferred treatment thresholds for all 24 users in Example 1 fall within this range. Alternatively, A may be set somewhere within the range of 1.4 to 2.0, and 19 out of 24 users have an optimal treatment threshold within this range. Or, A may be set somewhere within the range of 1.3 to 1.9, and 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 empirical parameters described above.

[0110] Steps S07 and S08 may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570.

[0111] In some embodiments, it is desirable to test the reliability of the current intensity when a sensory threshold is received, i.e., an indication of a user experiencing tactile sensation (i.e., the first user input received in step S06 or S06'). Block D (Reliability Determination) shown in Figure 7 comprises method steps relating to testing the reliability of the sensory threshold.

[0112] In step S101, an additional train of electrical stimulation pulses is provided by multiple electrodes, for example, the same multiple electrodes used for the pulses in step S05. Step S102 comprises receiving additional user input indicating that the user has experienced a cutaneous sensation, for example, a paresthesia, in relation to the additional pulse train in step S101.

[0113] An alternative step S102' comprises receiving additional user input indicating that the user experienced skin sensation associated with a pulse train during an additional series of electrical stimulation pulses, in which the current intensity increases, applied by a plurality of stimulating electrodes 102 to a specific area or multiple areas (e.g., anterior area) of the user's scalp. Step S102' may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. The pulses of step S101 or step S102' have a monotonically increasing current intensity as the series progresses, at a rate of increase that may be the same as or different from the rate of increase of the first pulse train of step S05 or step S06'. The user input of step S101 or step S102' is preferably received via a user interface 52 and / or onboard interface 180 of the mobile device 570.

[0114] If additional user input is received in step S101 or step S102', the reliability of the sensor threshold may be determined in step S103. This may involve comparing the current intensity at the time the additional user input is received with the sensory threshold defined in step S07. Steps S103 and S08 may be included in program instructions 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. In some embodiments, if the current intensity of the additional user input is within ±10% of the sensory threshold defined in step S07, the sensory threshold may be determined to be reliable. In some embodiments, if the current intensity of the additional user input is within ±20% of the sensory threshold defined in step S07, the sensory threshold may be determined to be reliable. In some embodiments, if the current intensity of the additional user input is within ±30% of the sensory threshold defined in step S07, the sensory threshold may be determined to be reliable.

[0115] As described later, the method step in block D can be repeated any number of times to test the reliability of the sensory threshold for the user. If, after a desired number of iterations, it cannot be determined that the sensory threshold is reliable, a treatment protocol based on default values ​​can be created and / or implemented. The default values ​​can be modified based on stored user information.

[0116] In some embodiments, it is desirable to verify the reliability of the current intensity when a sensory threshold, i.e., an indication of a user experiencing skin sensation (i.e., the first user input received in step S06 or S06'), is received. Block E (reliability verification) shown in Figure 8 comprises method steps relating to verifying the reliability of the sensory threshold.

[0117] In step S201, an additional electrical stimulation pulse train is provided by multiple electrodes, for example, the same multiple electrodes used for the pulse in step S05. In some embodiments, the pulse may be provided by multiple electrodes different from those used for the pulse in step S05. For example, the pulse in step S05 may be provided by multiple electrodes located anteriorly, and the pulse in step S201 may be provided by multiple electrodes located posteriorly. To complement the use of different multiple electrodes in step S201, as will be discussed later, there may be direct relationships between the respective therapeutic parameter sets set with respect to the multiple electrodes located anteriorly and the multiple electrodes located posteriorly, which are empirically derived in some embodiments. Step S202 comprises receiving additional user input indicating that the user experienced skin sensations associated with the pulse train in step S201, for example, paresthesia. Alternative step S202' comprises receiving additional user input indicating that the user experienced skin sensations associated with the pulse train during an additional electrical stimulation pulse train with increasing current intensity, which is applied by multiple stimulating electrodes 102 to a specific area or multiple areas (e.g., anterior area) of the user's scalp. Step S202' may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. 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.

[0118] The pulse in step S201 or step S202' increases monotonically with progression of the pulse series at a rate that may be the same as, or different from, the rate of increase of the first pulse series in step S05 or S06'. In contrast to these other steps, the pulse in step S201 or step S202' is interrupted by a pause before the current intensity increases to a level of the sensory threshold defined in step S07. Preferably, the pause occurs well before the sensory threshold level is reached so that the current intensity is not substantially the same as the sensory threshold (e.g., within 10% of the sensory threshold, within 20% of the sensory threshold, or within 30% of the sensory threshold). After a pause which may be less than one second, one second or more, or several seconds, the pulse series (and the increase in current intensity) continues until, in step S202 or step S202', user input is received indicating that the user has experienced a cutaneous sensation (e.g., paresthesia). If the user input in step S202 or S202' is received after the resumption of pulses after a pause (and with a current intensity value within an acceptable range from the sensory threshold), the sensory threshold is confirmed in step S203. On the other hand, if the user input in step S202 or S202' is received before or during a pause, i.e., well before the pulse reaches the sensory threshold defined in step S07, the sensory threshold is not confirmed in step S204.

[0119] Steps S203 and S204 may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570.

[0120] As will be described later, the method step of block E may be performed after the step of block B (definition of the sensory threshold) or after one or more cycles / repetitions of block D (determination of the reliability of the sensory threshold). In some embodiments, it may be preferable to perform block E before block C (setting the first therapeutic threshold).

[0121] Referring to Figure 9, block F (setting the second treatment threshold) comprises step S301, which includes setting the second treatment threshold based on the relationship between the second treatment threshold and the first treatment threshold. In a preferred embodiment, this 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 set of electrodes directed to a specific area or set of areas of the scalp, e.g., electrode 174. In some embodiments, the second treatment threshold relates to a posteriorly positioned electrode that generates electrical stimulation pulses directed to a posterior area(s) of the scalp. The treatment threshold may comprise a value or range of current intensity that is considered to provide effective transcutaneous nerve stimulation therapy. For example, the treatment threshold may be determined to be above a minimum value for paresthesia perceived by the user and below a maximum value for pain and / or discomfort perceived by the user. In some embodiments, the value of the treatment threshold is determined empirically by testing the user against the above minimum and maximum values. Example 2

[0122] Example 2 is an extension of Example 1 in that the direct relationship between the second treatment threshold and the first treatment threshold was empirically established using the same sample group consisting of 24 users of headset 100 for percutaneous nerve therapy. The table below summarizes the first treatment threshold (Tt) in milliamperes (mA), the second treatment threshold (Ot) in mA, and the Ot to Tt ratio, defined for each user according to the teachings of step S07. [Table 2]

[0123] Based on the results for 24 users, the Ot to Tt ratio has a minimum value of 1.9, a maximum value of 3.4, and an average value of 2.4.

[0124] The second treatment threshold in step S301 may be calculated by multiplying the first treatment threshold for the user by a multiplier B, based on the relationship between Ot and Tt shown in the empirical data. The multiplier B, based on the empirical data, may be set somewhere within a range that encompasses all or most of the preferred treatment thresholds for each user. For example, B may be in the range of 1.1 to 3.8, and the preferred treatment thresholds for all 24 users in Example 2 are within this range. Alternatively, B may be set somewhere within the range of 1.4 to 3.4, and again, the preferred treatment thresholds for all 24 users in Example 2 are within this range. Alternatively, B may be set somewhere within the range of 1.8 to 3.0, and 21 out of 24 users have an optimal treatment threshold within this range. Alternatively or additionally, the relationship between Ot and Tt may include other electrical parameters, such as any of the electrical parameters described above.

[0125] Step S301 may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570.

[0126] Referring here to Figures 10-13, flowcharts of method steps and "components" of method steps are shown according to various embodiments of the present invention, particularly relating to the calibration of the treatment threshold.

[0127] Referring to Figure 10, block G (head device) comprises step S305, which includes attaching a device to the user's head, the device having electrodes configured to provide electrical stimulation pulses of the type used in transcutaneous nerve stimulation therapy. In embodiments, this device may be a headset, such as one of the headsets 100 described above in this disclosure. The device may be one of the devices described above with reference to Figure 4 and block A in this disclosure. The device may be the same device used in block A and may still be in place from the steps of block A (and / or any other method steps). In some embodiments, block G comprises, in addition or alternatively, step S305a, which includes confirming that such a device is attached to the user's head. In some embodiments, confirmation is included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. In some such embodiments, confirmation may include receiving confirmation information from a sensor, such as a sensing electrode 104. In other such embodiments, confirmation may include receiving user input in the user interface 52 of the mobile device 570. Confirmation may further include prompting for user input at the user interface 52 before receiving user input. Additionally or alternatively, confirmation may include receiving user input via the onboard interface 180.

[0128] In some embodiments, it is desirable to have the user calibrate the treatment thresholds set in steps S08 and S301 during a dedicated calibration session. User calibration may include changing treatment protocol parameters, such as current intensity, to enhance the level of comfort during treatment. In some cases, the user may prefer to increase the current intensity, while in other examples, the user may prefer to decrease the current intensity or modify other electrical parameters. For example, decreasing the charge over time may involve increasing the current intensity by 5% while shortening the pulse duration by 10%. In other examples, the user may want to shorten or lengthen the electrical stimulation pulses of transcutaneous nerve stimulation therapy and / or increase or decrease their frequency. In some embodiments, system 101 may be configured to receive calibration input from such user and, accordingly, make the requested changes very quickly (e.g., less than 1 second, or less than 500 milliseconds, or less than 200 milliseconds, after the user has completed the changes). In some embodiments, system 101 may be configured to adjust the value of at least one additional parameter in response to user calibration input, in addition to the values ​​of the parameters directly modified by the user. For example, when a user changes the value of a current intensity treatment protocol parameter, the system 101 may be configured to adjust, for example, pulse width (duration), phase width, and / or frequency. One or more additional parameters may be automatically changed in response to the user calibration input to suit the treatment objective. For example, the treatment objective may be to maintain the overall average current so that the overall average current during treatment remains at a predetermined value. (One way to calculate the average current is to multiply the current intensity by the ratio of the phase width to the pulse width, and the average current is generally measured in milliamperes.) Thus, an increase in the phase width may be triggered by decreasing the current intensity. As another example, the treatment objective may be to maintain the average current within an acceptable variance range of a predetermined value (e.g., ±30%, ±20%, or ±10%). In either of these examples, the predetermined value may be the overall average current value prior to the user calibration input.

[0129] In some embodiments, a dedicated user calibration session may take place immediately before a treatment session, and in other embodiments, the calibration session may be an independent interaction with the system 101 and components such as a headset 100, and the mobile device 570 functions as a user input device by being executed by one or more processors 54 with command program instructions 51. In some embodiments, the calibration session may take place immediately after or shortly after the performance of step S301 (setting the second treatment threshold).

[0130] Referring to Figure 11, block H (modification of treatment threshold) comprises a group of method steps relating to user calibration of the treatment threshold.

[0131] In step S310, a calibration session is activated, and in some embodiments, the base (initial) treatment threshold is one set in steps S08 and S301, and in some other embodiments, one or both of the initial treatment thresholds have already been changed in a previous calibration session. Calibration may be initiated by the user or by a system running an application (executing program instructions 51) on a user input device (e.g., a mobile device 570). According to one embodiment, during the calibration session, electrical stimulation pulses are supplied to two parts of the user's scalp (e.g., the anterior and posterior parts).

[0132] Step S311 comprises receiving user calibration input from the user, and user activation changes may be made to the values ​​of any treatment parameters as described above. Alternative step S311' comprises receiving user calibration input after activation of the calibration session, using first and second current intensity treatment thresholds and / or other electrical parameter thresholds as the respective initial current intensities applied to two parts of the user's scalp (e.g., anterior and posterior), or equivalently, using the current intensity treatment threshold previously modified by the user in a previous calibration session. All user inputs, sensory thresholds, treatment thresholds, user calibration inputs, and other data related to and / or generated by system 101 may be stored in one of the external devices 150, as well as in an external server in the cloud (not shown). Step S311' may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570. The user calibration input in step S311 or step S311' is preferably received via the user interface 52 and / or onboard interface 180 of the mobile device 570.

[0133] In response to receiving user calibration input during a treatment session (step S311 or S311'), in step S312, a change is made to at least one treatment threshold. As described above, one or more other parameters may be modified to maintain therapeutic efficacy, for example, by keeping the overall average current within a predetermined range. Step S312 may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570.

[0134] Herein, we refer to Figure 12 illustrating Method Step Block I (Out-of-Range Indication) comprising step S320. In some embodiments, step S320 may, as an alternative or addition, include, in response to receiving user calibration input in step S311 or S311', providing the user with an indication that a change request embodied in the calibration user input received during the calibration session is an out-of-range therapeutic parameter for effective neurostimulation therapy. A user receiving such an indication, for example via the user interface 52 of a mobile device 570, may be given the opportunity to "correct" the calibration user input to remain within the recommended range of parameter values. Step S320 may be included in a program instruction 51 executed by one or more processors 54 of a user input device, such as a mobile phone 570.

[0135] Block J (activation of the treatment session) shown in Figure 13 comprises step S401, which includes activating transcutaneous nerve stimulation therapy using one or more treatment parameters modified in the calibration session.

[0136] Here, we refer to Figures 14-17, which show an example of a method including the components of the method steps described with reference to Figures 4-13, according to an embodiment.

[0137] Figures 14A-D show several options for setting the treatment threshold according to various embodiments.

[0138] In Figure 14A, a typical procedure is shown to include putting on / confirming that the headset is being worn (block A), defining the sensory threshold (block B), setting a first therapeutic threshold (block C), and setting a second therapeutic threshold (block F).

[0139] In Figure 14B, another typical method is shown to include putting on / confirming that the headset is being worn (block A), defining sensory thresholds (block B), determining the reliability of sensory thresholds (block D), setting a first treatment threshold (block C), and setting a second treatment threshold (block F).

[0140] In Figure 14C, another typical method is shown to include putting on / confirming that the headset is being worn (block A), defining a sensory threshold (block B), verifying the reliability of the sensory threshold (block E), setting a first treatment threshold (block C), and setting a second treatment threshold (block F).

[0141] In Figure 14D, another typical method is shown to include putting on / confirming that the headset is on (block A), defining a sensory threshold (block B), determining the reliability of the sensory threshold (block D), confirming the reliability of the sensory threshold (block E), setting a first treatment threshold (block C), and setting a second treatment threshold (block F).

[0142] Figure 15 shows another typical method that includes putting on / confirming that the headset is worn (block A), defining a sensory threshold (block B), and determining the reliability of the sensory threshold (block D), where the method steps in block D are repeated n times, n being an integer greater than 1 (in some embodiments n is 10 or less, in other embodiments 8 or less, and in yet other embodiments 6 or less). After n iterations, if in step S103 it is not determined that the reliability is within a given range, for example, if the sensory threshold is repeated with an accuracy of ±30%, ±20%, or ±10% (branch Q1), then step S500 is performed, which includes using a set of system default values ​​as the initial (pre-calibration) treatment threshold. If the answer to Q1 is affirmative, the method in Figure 15 proceeds to verify the reliability of the sensory threshold (block E). If reliability could not be verified (i.e., step S204 was performed), then step S500 (returning to the default initial treatment threshold) is performed. If the answer to Q2 is affirmative, the execution of the method further includes performing a method step to set a first treatment threshold (block C) and a method step to set a second treatment threshold (block F).

[0143] In some embodiments, other combinations of the disclosed method steps and components of the method steps may be performed, all of which are within the scope of the present invention. For clarification, it should be noted that whenever there is a discontinuity in the performance of any of the typical methods, the method steps of block A may be performed.

[0144] Figures 16-17 show options for completing the calibration of the treatment threshold according to various embodiments.

[0145] In Figure 16, a typical method is shown to include putting on / confirming that the headset is worn (block G), changing at least one treatment threshold in a calibration session (block H), indicating that the user calibration input takes an out-of-range value (block I), and activating the treatment session based on one or more values ​​changed in the calibration session (block J). Not all steps and blocks of the method are required in all embodiments. For example, in some embodiments, block G is performed only if the method is not performed consecutively after one of the methods (or its equivalent) in Figures 13-15 where the headset is already in place. Block I is performed only if the received user calibration input takes a treatment parameter outside the desired range. Block J is optional, as the calibration session may not directly follow an actual transcutaneous nerve stimulation session.

[0146] Figure 17 shows another typical method which optionally includes putting on / confirming that the headset is worn (block G) and changing at least one treatment threshold in a calibration session (block H). If the incoming input for the change (in Q3) is out of range, block I is performed. If there is no incoming input for the change (in Q3), the method continues and block J (activating an actual treatment session with at least one changed treatment parameter) may be performed optionally. If block I is called in branch Q3, step S321 may be performed to receive a new user calibration value. If a new or "appropriate" (in-range) user calibration input is received in step S321 (in Q4), block J (activating an actual treatment session with at least one changed treatment parameter) may be performed optionally, and if no new / appropriate / in-range user calibration is received (i.e., determined so in Q4), in step S501, the system retains the previously set treatment threshold by default.

[0147] Figure 18 schematically illustrates other typical methods in which one of the four methods described with reference to Figures 14A-D can be joined "end to end" with the method in Figure 16.

[0148] Figure 19 also schematically illustrates another typical method in which the method in Figure 15 can be joined "end to end" with the method in Figure 17.

[0149] Any of the methods shown in Figures 13-19, or their equivalents, may be included in a program instruction 51 (for example, for an application) to be executed by one or more processors 54 of the mobile device 570.

[0150] As will be apparent to those skilled in the art, the examples and embodiments described herein are not limited to the “first set the front threshold, then set the rear threshold” example that has been used for convenience throughout much of this disclosure.

[0151] For example, a sensory threshold may be determined using a set of electrodes directed towards the rear, and then this sensory threshold may be "converted" to a rear therapeutic threshold, and the rear therapeutic threshold may be "converted" to an anterior therapeutic threshold, both of which are based on empirically derived relationships of their respective current intensity thresholds.

[0152] As another example, any number of different cranial or peripheral nerves that are targets of transcutaneous nerve stimulation therapy may be addressed in a desired order, and the treatment threshold may be set according to empirically derived relationships between different regions or nerves (or groups of nerves) in that desired order. In some embodiments, the target nerve branches may be located laterally on the left and right sides of the user's head.

[0153] The following is an example of a sequence in which treatment thresholds can be determined for various nerve branches or regions of the user's scalp, with respect to two sets of electrodes targeting two regions of the scalp (A=anterior, P=posterior, LL=left side, RL=right side): AP, A-LL, A-RL, PA, P-LL, -RL, LL-A, LL-P, LL-RL, RL-A, RL-P, and RL-LL. It is clear that if three or more regions of the scalp are targeted, a corresponding number of electrodes are used, and the number of possible combinations increases accordingly.

[0154] As is also clear, the embodiments are not limited to the user's head but may be applied to any limb and body region, in which case empirical relationships can be derived between sensory thresholds and therapeutic thresholds, and between various therapeutic thresholds.

[0155] Any such modifications applied to the methods and devices disclosed herein are clearly within the scope of the present invention.

[0156] Whenever it is stated that a given method step or a given group of method steps "may be included" in a program instruction, as used herein, it should be understood that an instruction for performing the given method step or a given group of method steps may be included in the program instruction, and that the execution of the program instruction (for example, by one or more computer processors or one or more processors of a mobile device as needed) may cause one or more processors to perform the given method step or a given group of method steps, or cause one or more processors to perform the given method step or a given group of method steps.

[0157] As used herein and in the following claims, the term “or” is considered inclusive; therefore, the expression “A or B” means any of the groups “A,” “B,” and “A and B.”

[0158] As used herein and in the following claims, the term “pulse” refers to an electrical signal applied, for example, through an electrode or sensed by an electrode.

[0159] To ensure clarity, certain features of the invention described in the context of individual embodiments may be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for brevity may be provided individually or in any suitable partial combination. Similarly, the content of a claim dependent on one or more specific claims may generally depend on other unexpressed claims, or be combined with them, provided there is no particular apparent inconsistency between them.

[0160] Although the present invention has been described with reference to specific embodiments, it will be apparent that numerous changes, modifications, and variations will be evident to those skilled in the art. Therefore, it is intended to encompass all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. A method for operating a medical device to determine user-specific treatment parameter values ​​for multi-channel transcutaneous nerve stimulation therapy applied to multiple locations on the user's scalp, a. A step of setting a first set of treatment parameter values ​​relating to a first electrode array adapted to engage with a first portion of the user's scalp for administering electrical pulses using the medical device, The first set of treatment parameter values ​​is set according to a first correlation, the first correlation includes a first direct relationship between at least one parameter value in the first set of treatment parameter values ​​and the corresponding at least one parameter value in the set of user-proprioceptive threshold parameter values, b. The step of setting the second set of treatment parameter values ​​with respect to a second electrode array adapted to engage with a second portion of the user's scalp to administer electrical pulses, according to a second correlation including a second direct relationship between at least one parameter value of the second set of treatment parameter values ​​and the at least one parameter value of the first set of treatment parameter values, using the medical device. Includes, (i) the first portion of the scalp is the anterior portion and the second portion of the scalp is the posterior portion, or (ii) the first portion of the scalp is the posterior portion and the second portion of the scalp is the anterior portion, The first set of treatment parameter values ​​and the second set of treatment parameter values ​​each include charge parameter values ​​and the following: Current intensity parameter; An arithmetic combination of pulse duration parameter and frequency parameter, or both of the pulse duration parameter and frequency parameter. It is characterized by including at least one of the following treatment parameter values: According to the first direct relationship, the charge parameter value of the first treatment parameter value set is equal to the number obtained by multiplying the charge parameter value of the user proprioceptive threshold parameter value set by A, where A is 1.3 or greater and 1.9 or less. According to the second direct relationship described above, the charge parameter value of the second set of treatment parameter values ​​is equal to the number obtained by multiplying the charge parameter value of the first set of treatment parameter values ​​by B, where B is between 1.1 and 3.

8. How to operate a medical device.

2. The charge parameter values ​​of the first treatment parameter value set and the second treatment parameter value set are The value of the total charge over a given period of time that is an integer multiple of the reciprocal of the electrical pulse frequency. The operating method according to claim 1.

3. The operating method according to claim 1 or 2, wherein the second direct relationship is partially based on the relationship of the respective electrode surface areas of the first and second electrode arrays.

4. The operating method according to any one of claims 1 to 3, wherein the correlation is a linear relationship based on empirical correlation.

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