Neuromodulation devices, systems, and methods

Abstract

Therapeutic electrical stimulation devices, system and methods are disclosed. A management application (3) is provided on a management device (2) via which at least one user input is received for specifying the operation of a stimulation device. The user input is converted into a set of instructions that are transmitted from the management device to a stimulation device (1). The stimulation device (1) is configured to deliver electrical signals in accordance with the user input.

Description

[0001] Neuromodulation devices, systems, and methods

[0002] Field of the invention

[0003] The present invention relates to therapeutic systems and methods for applying electrical signals for the treatment of neurological disorders, such as Tourette's syndrome. Particular embodiments of the invention relate to the configuration of a peripheral nerve stimulation device for use in therapeutic neuromodulation.

[0004] Background to the invention

[0005] Neurological disorders such as Tourette's syndrome (TS) cause involuntary movements and utterances, known as tics. This can be alleviated via the application of electrical signals to peripheral nerves, such as those located below the wrist. These signals are propagated to the central nervous system where they can modify neural oscillations associated with the cause of tics. However, the characteristics of the electrical stimulation that provides the most effective tic relief can vary from person to person, and depending on various factors such as stress, time of day, electrode placement, current intensity and frequency. Determining the most effective stimulation characteristics can be difficult and time consuming, due in part to anatomical and physiological variations between individuals.

[0006] To provide effective relief, however, stimulation ideally needs to be performed using an unobtrusive and practical wearable device. This is achieved using a relatively simple peripheral nerve stimulation device.

[0007] An example peripheral nerve stimulation device, and a discussion of the treatment of neurological disorders such as TS is contemplated by the inventors of the present application in patent publication number W02021 / 005584 the disclosure of which is incorporated by reference in its entirety to the extent permitted by applicable law.

[0008] To minimise the complexity of such a device, the user interface of such a device is typically limited to a few buttons to turn the device on and off, start and stop, and to vary the intensity of the electrical stimulation.

[0009] The device is thus typically configured in a generic way, providing little user customisation, and adaptation to different factors and conditions.

[0010] Additionally, if the device is located underneath clothing, and at an inconvenient position on the body, this can make operating and adjusting the stimulation device problematic. This is particularly the case if a user is undertaking certain activities such as driving, for example.

[0011] Furthermore, the stimulation device may be accidentally triggered, changing settings or inadvertently activating or deactivating the device.

[0012] During interaction with such a device, it may make bleeps or other noises as audio operation feedback. This can be useful when the device is hidden from view, and so visual feedback via the device itself isn't practical. However, under many circumstances this is undesirable and potentially a cause of embarrassment for a user, raising their stress levels, and so exacerbating tics.

[0013] TS and similar neurological disorders may exist across family members. This necessitates the use separate wearable neuromodulation device for each family member, uniquely customised to deliver electrical stimulation according to their individual needs. In such circumstances where several devices may be used by individuals living in proximity to one another, an individual may inadvertently use a device which is not configured to their individual preferences, or otherwise it would be arduous to reconfigure the stimulation device. Alternatively, an individual may have several wearable stimulation devices configured to be worn at different locations around the body. In such circumstances, it is desirable to ensure that the appropriate device is used for the appropriate location, and that correct electrode placement is facilitated.

[0014] It is against this background that the present invention has been devised.

[0015] Summary of the invention

[0016] According to a first aspect of the present invention there is provided a therapeutic electrical stimulation system. The system may comprise at least one of: a wearable nerve stimulation device, a management application, and a management device. Preferably, the management device is configured to execute the management application. The stimulation device may comprise at least one of a communication interface, and an electrode assembly. Preferably, the electrode assembly is suitable for delivering a sequence of electric signals to nerves of a user wearing the device.

[0017] Preferably, the management device comprises at least one of: a user interface and a communication module. Preferably, the management device is configured by the management application. The management device may be configured by the management application to generate a set of instructions to be sent to the stimulation device. Moreover, the management device may be configured by the management application to: receive at least one user input, ideally via the user interface, for specifying the operation of the stimulation device, and convert the at least one user input into a set of instructions; and / or connect, via the communication module, with the communication interface of the stimulation device, and transfer the set of instructions to the stimulation device.

[0018] The set of instructions include a variety of data that can be used to alter the operating behaviour of the stimulation device, such as parameters for adjusting the intensity of the stimulation, the duration of the stimulation, the frequency of stimulation, the conditions under which stimulation is triggered, and others. Preferably, the stimulation device is configured by the set of instructions received from the management device to deliver a sequence of electrical signals, via the electrode assembly. The electrical signals can thus be delivered as specified by, or otherwise in accordance with the at least one user input. Advantageously, this allows the stimulation device to be a relatively simple device, with a limited interface that has a lower chance of being accidentally triggered than one necessitating a more sophisticated interface. However, it can be flexibly customised via the management device, and even remotely activated via the management device, allowing for a user to use the device under circumstances where direct access to the device is inconvenient. As the user interface of the management device is used for control, which is remote from the stimulation device, it is more conveniently accessed. Visual operational feedback can be provided via the management device, instead of audio feedback from the stimulation device, allowing the device to be operated in circumstances requiring quietness or discretion. This improves the user experience and reduces stress.

[0019] In certain aspects, the management device can be in the form of a portable device such as a smartphone already owned by a user. In alternatives, the portable device may include smartwatch, other wearable devices such as smart glasses, handheld devices, and others. This reduces the overall cost of providing the therapeutic system, and also promotes further discreet and low-stress operation. Operating the stimulation device via a management device like a smartphone is highly unlikely to attract unwanted attention to the user from others.

[0020] Preferably, the at least one user input is operable by a user to specify at least one of:

[0021] - a usage parameter, such as the location of the body that the stimulation device will be worn; - an intensity of the electrical signals for nerve stimulation; and

[0022] - a pattern of the sequence of electrical signals for nerve stimulation.

[0023] Advantageously, specifying the usage parameter allows the operation of the stimulation device to be controlled to optimise its intended use. For example, if the usage parameter specifies the location of the body, the appropriate electrode activation for that location can be used to maximise the efficacy of the electrical stimulation. One example of this relates to wearing the device on the left wrist versus the right wrist. The polarity and position of the activating electrodes is important. Specifying, via an appropriate user input, on which wrist the stimulation device is to be worn therefore allows the management device to generate and transfer a set of instructions to the stimulation device that controls it to activate the electrodes in the most effective way.

[0024] Preferably, the management device is configured by the management application to enact a set-up process to customise the operation of the stimulation device for a user, the set-up process comprising at least one of: a manual set-up process; and an automated set-up process. Preferably, the setup process comprises displaying, on the user interface of the management device: guidance for optimising the operation of the stimulation device for a respective user; and / or a set of user-interactable elements configured to: receive a sequence of user inputs to iteratively tune the operation of the stimulation device towards an optimal setting for that respective user; and receive a save command to store the optimal setting for that respective user. Preferably, iteratively tuning comprises alteration of an intensity of the electrical signals. Preferably, the optimal setting for that respective user is stored within user profile data associated with that user. Preferably, guidance displayed via the user interface of the management device includes a prompt to increase the intensity of the electrical signals until a physiological phenomenon, such as a hand, finger or muscle twitch, commonly a thumb twitch, can be observed or felt by the user. The optimal setting may be set as an intensity that is between 50% and 99% below that which that causes physiological phenomenon. Preferably, the optimal setting is set as an intensity that is between 65% and 95% below that which that causes physiological phenomenon. Advantageously, these ranges have been determined to be effective at inducing neuromodulation without significant side effects caused by physiological responses to stimulation, such as involuntary body movement.

[0025] Preferably, an automated setup process comprises at least one of: displaying, on the user interface of the management device, guidance to position a sensor of the management device, such as a camera, relative to a part of the user's body; automatically recognising correct positioning of the sensor relative to the part of the user's body; automatically starting the iterative tuning of the operation of the stimulation device; monitoring the part of the user's body via the sensor, during the iterative tuning, to detect a physiological phenomenon, such as a thumb twitch, indicating an optimal setting; and determining and storing the optimal setting for a respective user against their user profile data. Preferably, the optimal setting is determined relative to stimulation settings causing the detected physiological phenomenon. For example, the optimal setting associated with stimulation current intensity is determined to be a percentage, under 100%, of the stimulation current intensity that is applied during tuning, and that causes the detected physiological phenomenon such as a thumb twitch. As above, determining the optimal setting may comprise setting an intensity that is between 50% and 99% below that which that causes physiological phenomenon. Preferably, the optimal setting comprises setting an intensity that is between 65% and 95% below that which that causes physiological phenomenon. Preferably, as part of the stimulation setup process, an assessment of the sensory phenomenon associated with Tourettes syndrome and other tic disorders is inputted by the user. This for example could be a subjective rating of the premonitory urge sensations which may precedes tics. Alternatively, an input relating to the relief felt by the user due to the stimulation maybe used. These inputs may be used to determine or guide adjustments to increase or decrease stimulation intensity or to indicate when effective stimulation levels have been reached. Preferably, the sensor is a camera, and the management device applies automatic image recognition of the part of the user's body for positioning and monitoring. Preferably, the guidance to position the sensor includes repositioning guidance, issued in response to detecting a suboptimal positioning of the sensor relative to the user body part.

[0026] Preferably, the set-up process comprises at least one of: receiving a user input to specify a part of the body on which the stimulation device is worn for the set-up process; and automatically detecting a part of the body on which the stimulation device is worn for the set-up process. Preferably, the set-up process comprises: guidance, displayed via the user interface of the management device, for guiding a user to operate the management device to obtain an optimal stimulation setting; and / or saving of the optimal stimulation setting on at least one of: the stimulation device and the management device, for use during a therapeutic activation of the stimulation device. Preferably, the set-up process comprises a manual set-up process in which: the user interface of the management device provides at least one user input for controlling stimulation intensity, user interaction with that at least one user input being communicated from the management device to the stimulation device for respective control of electrical signal intensity. Preferably, the set-up process comprises a manual set-up process in which the user interface of the management device provides a user input for saving an optimum stimulation intensity. Preferably, the set-up process comprises a manual set-up process in which an optimum stimulation intensity is automatically saved following user interaction to control electrical signal intensity. Preferably, the set-up process comprises an automated set-up process in which: the stimulation device is activated to perform a range of electrical stimulation; the management device is configured to receive physiological response information dependent on a user body response to the range of electrical stimulation from the stimulation device; the physiological response information is processed to determine a threshold condition, such as a thumb twitch, with which an optimum stimulation intensity is associated; and / or the optimum stimulation intensity is determined and saved.

[0027] Preferably, processing of the physiological response information comprises applying a classifier function, such as a neural network trained to detect the threshold condition with which the upper limit of an optimum stimulation intensity is associated. Preferably, the physiological response information comprises images of a part of the user body influenced by the range of electrical stimulation, and the classifier function comprises applying an image classifier. Preferably the output of the image classifier is analysed in the frequency domain to recognize repeated cyclic motions associated with the twitch produced with stimulation.

[0028] Preferably, the management device is configured by the management application to detect a position of the stimulation device relative to a part of a body on which the stimulation device is worn and, in response, provide feedback, via the user interface, about how the relative positioning of the stimulation device and the part of the body can be improved to optimise stimulation device efficacy in use.

[0029] Preferably, the management device comprises a camera configured by the management application for use in detecting the position of the stimulation device relative to the part of a body on which the stimulation device is worn. Preferably, the stimulation device comprises at least one sensor. The at least one sensor may be for determining a location of the body at which the stimulation device is worn, and wherein at least one of: the intensity of the electrical signals for nerve stimulation; and the pattern of the sequence of electrical signals for nerve stimulation; are automatically selected by the stimulation device in dependence on the determined location of the stimulation device. Preferably, the at least one sensor comprises an inertial measurement unit (IMU). Preferably, the stimulation device is configured to be wrist-worn, so that the electrode assembly is positioned against the underside of a wrist of a user, adjacent to and arranged to stimulate at least one of a median nerve, an ulnar nerve and radian nerve of the user, via transcutaneous electrical stimulation.

[0030] Preferably, the electrode assembly comprises a pair of conductive pads, for promoting comfortable electrical conduction and reliable electrode-to-skin contact. Preferably, the pads have a skin-facing surface that grips the skin. Advantageously, this prevents relative movement between the stimulation device and the skin of the user, thereby ensuring that an otherwise correct placed stimulation device is not unintentionally misaligned. The pads may be self- adhesive to attach to the stimulation device or have a button connection interface.

[0031] Preferably, the stimulation device comprises an underside surface for contacting with a user's skin in use, the electrode assembly having a pair of contacts that are set into the underside surface and the pair conductive pads are detachably attachable to a respective contact. Preferably, the underside surface is contoured in the region of the contacts to define a pair of recesses for accommodating the respective pair of conductive pads so that skin-facing surfaces of the pads are substantially level with one another. Preferably, the skin-facing surfaces of the pads are slightly raised, or substantially level with a peripheral region of the underside surface around the contacts. Preferably, the stimulation device comprises a body for housing at least a power supply, the electrode assembly being repositionable relative to the body to allow electrode location customisation. Preferably, the electrodes are moveable between a left-hand and right-hand configuration. Preferably, each electrode is moveable along a respective track, the tracks ideally extending transverse to a body part to which the stimulation device is attached in use. Preferably, the electrode assembly comprises an electrode interface adapter configured to allow modular attachment one or more electrode interface pieces. Preferably, the electrode interface pieces comprise plates that are configured to slide relative to the electrode interface adapter to attach and detach therefrom. Advantageously, these features facilitate electrode placement for the targeting of specific nerves for neuromodulation.

[0032] Preferably, the stimulation device comprises indicia for indicating which way the device should be oriented, depending on a wear location. Preferably the stimulation device comprises indicia for indicating the correct mounting and positioning of gel pads over the electrode surfaces. Advantageously, this serves as a reminder to correctly fit gel pads in case they are forgotten or misaligned relative to the electrodes. Preferably, the stimulation device comprises indicia indicating which way the device should be oriented, depending on whether the stimulation device is worn on the left- or right-hand side wrist.

[0033] Preferably, the stimulation device comprises controls for user-control of the operation of the stimulation device, the controls comprising at least one of: an activation switch for switching the device between an active configuration in which electric signals are delivered via the electrode assembly, and a passive configuration in which the electrode assembly is deactivated; and mode selectors for selecting a mode of electrical signal delivery.

[0034] Mode selectors may also be used to select device modes such as to enable adjustment of stimulation parameters, or to place the device in airplane or low power mode. Preferably, the stimulation device comprises at least one status indicator for indicating to a user: a mode of electrical signal delivery; and / or a status of a power supply. Preferably, the stimulation device is configured to receive tic data, and deliver the sequence of electrical signals in dependence on the tic data. Preferably, the tic data comprises a determination of the occurrence and intensity of at least one of a: user vocal tic and a user physical tic. Preferably, the sequence of electrical signals is delivered in dependence on the tic data in a feedback loop to minimise the intensity of the at least one user vocal tic and a user physical tic. Preferably, the stimulation device comprises, or is connected to a microphone for the detection and determination of a user vocal tic. Preferably, the stimulation device comprises, or is connected to a movement sensor for the detection and determination of a user physical tic. Preferably, the stimulation device is configured to receive tic data, and deliver the sequence of electrical signals in dependence on the tic data in combination with response data, the response data being generated by measuring user manual activation of the stimulation device to deliver electrical signals following a tic.

[0035] Preferably, the stimulation device comprises a power supply and a power supply management module configured to: monitor the power supply, and transmit power supply information to the management device, the management device being configured to display the power supply information via the user interface; and / or monitor usage of the stimulation device, and switch the stimulation device between a low-power state and a normal state in dependence on whether the device is being worn and / or actively used. Preferably, the power supply of the stimulation device is rechargeable, and the stimulation device further comprises a recharge port via which the power supply is connectable to an external power source for recharging.

[0036] Preferably, the stimulation device comprises a detachably attachable identifier, having indicia for personalising the stimulation device. Advantageously, this provides a way to make the stimulation device uniquely identifiable to a particular user. Indicia can serve as a means of personalisation, with specific customisable design features assisting identification and recognition of multiple devices by one or more users of those devices.

[0037] Preferably, the sequence of electrical signals delivered by the electrode assembly of the stimulation device are characterised by at least one of: voltages up to 170 volts; currents up to 20 milliamps; at least one pulse train having 100-200 microsecond pulses; at least one pulse train having a frequency between 3-30 Hertz; and a waveform that is substantially charge balanced. Preferably, the stimulation device comprises a stimulation feedback controller for regulating at least one of the current and the voltage at a stable level.

[0038] Preferably, the system comprises a plurality of nerve stimulation devices wearable by a common user, each configured to communicate so that they can deliver electric signals that are coordinated with one another to the nerves of the common user.

[0039] Preferably, the system comprises a body use detector for detecting use of a part of a user body on which at least one of the plurality of nerve stimulation devices are worn, the delivery of electric signals by the plurality of nerve stimulation devices being controlled in response to the detected use of a body part by the body use detector. Preferably, the detected use comprises detection of fine motor skills, such as writing or typing.

[0040] Preferably, the management device is a portable management device, such as a smartphone, smart watch, smart wearable or tablet configured to download the management application from an application server.

[0041] Preferably, the management device is configured to display, via the user interface, a user selection prompt, the prompt being configured to receive an input to select an identity of a user of the stimulation device, and in response access user profile data, associated with the selected user, for use in specifying the operation of the stimulation device. Preferably, the management device communicates with the stimulation device to specify that the selected user is the active user. Preferably, the management device and / or the stimulation device is configured to persistently display, via the user interface, a user identifier associated with the active user selected via the user selection prompt, thereby guiding against misuse by one user of another user's settings. Preferably, the management device is configured to store usage data, such as time and duration of manual activation of the stimulation device, within the user profile data associated with the selected active user. Preferably, stimulation device comprises a user selection interface, the user selection interface being configured to receive an input to select between multiple users of the stimulation device, and in response access user profile data, associated with the selected user. Preferably, at least one of the stimulation device and the management device is configured to display a user identifier associated with the active user selected via at least one of the user selection interface of the stimulation device, and the user selection prompt of the management device. Preferably, the stimulation device and the management device communicate to transfer user profile data between one another. Preferably, the user profile data includes at least one optimal setting for that user, as stored during a setup process. Preferably, the system comprises a user profile server, the management application configuring the management device to receive user credentials, and in response synchronise user profile data with the user profile server. Preferably, the user profile data comprises the at least one user input for specifying the operation of the stimulation device. Preferably, the user profile data comprises at least one of: usage data, and user-specified parameters.

[0042] According to a second aspect of the present invention there may be provided a method of therapeutic electrical nerve stimulation, comprising at least one of: executing a management application on a management device; receiving at least one user input for specifying the operation of a stimulation device, and converting the at least one user input into a set of instructions; and transmitting the set of instructions from the management device to a stimulation device for configuring the stimulation device to deliver electrical signals in accordance with the at least one user input.

[0043] According to a third aspect of the present invention there may be provided a computer program comprising instructions which, when executed on a management device configures the management device to execute the method according to the second aspect, at least in part.

[0044] It will be understood that features and advantages of different aspects of the present invention may be combined or substituted with one another where context allows.

[0045] For example, the features of the system described in relation to the first aspect of the present invention may be provided as part of the method described in relation to the second aspect of the present invention, and / or the computer program of the third aspect and vice-versa.

[0046] Furthermore, such features may themselves constitute further aspects of the present invention, either alone or in combination with others.

[0047] For example, the features of the stimulation device, the management application, the management device may themselves constitute further aspects of the present invention.

[0048] Brief description of the drawings

[0049] In order for the invention to be more readily understood, embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0050] Figure 1 is a schematic block diagram of a therapeutic electrical stimulation system according to various embodiments of the present invention, the system comprising at least one electrical stimulation device, a management device, and a management server;

[0051] Figure 2 is a schematic block diagram of the management device and management server of Figure 1;

[0052] Figure 3 shows two views of the stimulation device of Figure 1;

[0053] Figure 4 shows an alternative embodiment of the stimulation device to that shown in Figure 3;

[0054] Figure 5 is a schematic block diagram of electronic control circuitry for stimulation devices according to various embodiments of the invention;

[0055] Figure 6 is a graph showing an example of the stimulation output during a setup process for stimulation devices according to various embodiments of the invention;

[0056] Figure 7 is a schematic flow diagram illustrating the setup process for stimulation devices according to various embodiments of the invention;

[0057] Figure 8 shows an illustration of a stimulation device according to various embodiments;

[0058] Figure 9 is a schematic illustration of a mobile device running a management application according to various embodiments of the invention;

[0059] Figure 10 is an alternative schematic illustration of the mobile device of Figure 9;

[0060] Figure 11 is a schematic diagram of an image processing pipeline as applied by the system of embodiments of the invention;

[0061] Figure 12 is a schematic diagram of an alternative processing pipeline to that of Figure 11 ;

[0062] Figure 13 is a time-series graph showing a kinematic signal associated with movement caused by a stimulation device of various embodiments of the invention;

[0063] Figure 14 is a graph showing the result of a Fast Fourier Transform FFT of the signal of Figure 13;

[0064] Figure 15 shows two additional variations of the stimulation device according to various embodiments, each being worn on the left hand of user;

[0065] Figure 16 is a set of views of the mobile device and stimulation devices according to various embodiments of the present invention;

[0066] Figure 17 is a schematic view of an example implementation of an instruction set for the devices of in Figure 16;

[0067] Figure 18 shows a view of two stimulation devices according to various embodiments of the invention;

[0068] Figure 19 shows views of a variation of the stimulation device according to various embodiments of the present invention;

[0069] Figure 20 is a partial side view of the stimulation device of Figure 19;

[0070] Figure 21 shows an electrode interface piece compatible with the stimulation device of Figure 20; and

[0071] Figure 22 shows a side view of components of a stimulation device according to a further embodiment of the present invention.

[0072] Specific description of the preferred embodiments

[0073] Figure 1 shows a schematic block diagram of a therapeutic electrical stimulation system 1S according to various embodiments of the present invention, the system comprising at least one wearable electrical stimulation device 1. Although only one stimulation device 1 is shown in Figure 1 , it will be understood that the system 1S supports multiple stimulation devices as well as other wearable devices. The stimulation device 1 is primarily intended as a therapeutic neuromodulation device that applies electric signals, via an electrode assembly arranged for transcutaneous electrical nerve stimulation (TENS), to peripheral nerves located underneath the wrist. However, in alternatives, the stimulation device may be applied at other locations on the body and may be alternatively arranged - for example to fit around the leg, upper limbs or other parts of the body. Naturally, when multiple stimulation devices are used, each can be for different parts of the body.

[0074] In each alternative, the use of the stimulation device 1 cause electric signals to propagate to the central nervous system where they can modulate neural oscillations that cause tics associated with Tourette's syndrome, or alleviate the symptoms of other neurological health conditions.

[0075] The system 1 S, also comprises a management device 2 in the form of a mobile computing device 2, and a management server 4. The management server 4 implements cloud computing infrastructure such as data storage and at least one back-end application as will be discussed below. The system 1S also comprises an application server 4a from which a management application 3 is downloadable on to the management device 2 for execution. When the management application 3 is executed on the management device 2, it specifically configures the management device 2 to operate as a component of the electrical stimulation system 1S. Prior to this, the unconfigured management device 2 is unable to function as part of the system 1S.

[0076] In relation to the present and similar embodiments, the term management device 2 and mobile computing device 2 may be used interchangeably. The term management application 3 and mobile application 3 may be used interchangeably. The term stimulation device 1 and neuromodulation device 1 may be used interchangeably.

[0077] The application server 4a may be in the form of a single platform, or a combination of several different platforms - such as the Apple® Appstore®, the Google® Play ™ Store, and / or the Microsoft® Store - but merely for simplicity this is represented as a single entity in Figure 1. In alternatives, the management server 4 may provide the role of the application server 4a. The application server 4a may be separate from the system 1S.

[0078] The components of the system 1 S, as well as the components that interact with the system are communicatively interconnected with one another via one or more communication networks. In various embodiments, the networks may be embodied by a wired and / or wireless local area network (LAN), peer-to-peer wireless connections (e.g. using at least one of Bluetooth® and direct Wi-Fi), a wide area network (WAN) such as the Internet, GSM network or a combination of these.

[0079] In the current embodiment, the management device 2 comprises a communication module for connecting with a complementary communication interface of the stimulation device 1 establishing a peer-to-peer wireless connection between them. In the current embodiment, the peer-to-peer wireless connection is a Bluetooth® connection, with both the communication module of the management device 2, and the communication interface of the stimulation device 1 comprising a Bluetooth® module. However, in alternatives, other wireless connections are possible.

[0080] The management device 2 connects to the servers 4, 4a across the internet, for example through a wireless Wi-Fi module via which a connection to a broadband router and then the internet can be established. This allows certain functionality to be achieved as will be described below. Nonetheless, the mobile computing device 2 and mobile application 3 may operate without connectivity to the cloud-based applications and resources of the management service 4, albeit without access to the additional functionality provided by the management server 4. In preferred embodiments, the mobile computing device 2 is a smartphone or tablet, or any personal and portable computing device which can provide wireless connectivity to the wearable stimulation device 1. It is advantageous to be able to use a relatively ubiquitous device, such as a smartphone, as this permits the user to configure and operate the stimulation device discreetly, thereby reducing stress on the user that could otherwise exacerbate tics. Also, a device such as a smartphone that is already possessed and habitually carried by the user usefully reduces the size and cost of the stimulation device 1 without inconveniencing the user with needing to remember to also carry a dedicated ancillary unit for remote control.

[0081] However, other implementations of the management device as configured by a management application are contemplated within this disclosure. In certain alternatives to the embodiments described herein, a custom-designed ancillary device may be used instead.

[0082] The mobile computing device 2 comprises a touch-sensitive screen 2a on which can be displayed user-interface (Ul) elements. Moreover, the management application 3 configures the mobile device 2 with Ul control functions 8, including the display of Ul elements associated with the management of the stimulation device 1. These can communicate a state of the mobile device computing 2, or other components of the system 1 S, such as the stimulation device 1 to a user. The Ul elements also provide a means by which a user can input information to the mobile computing device 2. This is done via interacting with those Ul elements - for example via a touch-interaction with the touch-sensitive screen. The Ul elements may include a virtual electronic keyboard, as is known in the art, for inputting data such as alphanumeric characters. Ul elements may also include virtual buttons and sliders. The mobile devices' sensors including motion, microphone and camera also provide the means for inputting data.

[0083] At a general level, the mobile computing device 2 is configured by the management application 3 to receive user input, via the user interface, that specifies the operation of the stimulation device 1 or to input data associated with the demand for stimulation. The user input is converted into a set of instructions, including parameters, that are transmitted from the communication module of the mobile computing device 2 to the communication interface of the stimulation device 1. The stimulation device 1 is configured by the set of instructions received from the management device 2 to deliver a sequence of electrical signals, via the electrode assembly, the sequence of electrical signals being dependent on the user input provided.

[0084] The user can operate the user interface of the mobile computing device 2 to specify usage parameters, such as the location of the body that the stimulation device 1 will be worn. The user can also specify an intensity of the electrical signals for nerve stimulation, and a pattern of the sequence of electrical signals for nerve stimulation. These user inputs are converted into the appropriate instructions that are sent to the stimulation device 1, and then used to control the activation of the stimulation device 1. The stimulation device 1 also communicates with the mobile computing device 2, for example status information about battery levels, and data about the operating behaviour of the stimulation device. Such data may include temporal usage data, especially if the stimulation device 1 is activated and deactivated directly by the user.

[0085] Generally, this arrangement has the benefit of permitting the stimulation device 1 to be in the form of a relatively simple unit, with a simplified interface of its own. As the stimulation device 1 may be worn underneath clothing, it can be conveniently controlled and configured from the management device 2 without the user needing to frequently manually interact with the stimulation device 1 itself. Moreover, the simple interface reduces the chance of the device being accidentally triggered or it's functionality maladjusted. Nonetheless, a more sophisticated interface is provided remotely, via the user interface of the management device 2, which can provide visual feedback, improving the overall user experience. The user interface controls 8 and associated logic controls 9, via the screen 2a of the management device 2 provide a user with indication of wearable status and settings parameters as well as to provide controls to adjust TENs stimulation settings and parameters. In another implementation of the management application 3, it provides the means to coordinate and control several wearable stimulation devices which may be worn simultaneously on the body as will be discussed further below with reference to Figures 16 to 18.

[0086] The management application 3 includes a diary function 11 to enable users to enter outcome health and well-being data. Features to display outcome and usage data trends, such as charts and audio-visual notifications are also contemplated. The management application 3 may also include alerts and alarms features 10 to help provide indication to the users relating to the functionality of the wearable device or to act as reminders relating to diary functions or to synchronise their wearable to ensure data retention and storage in a data store 6 of the management server 4.

[0087] In an example implementation of the management application 3, it is provided as a web application, connecting to a back-end database provided by the management server 4 via cloud infrastructure applications. In such an implementation the back-end database 6 forms the master data record and is related to users and their profiles including linked device settings and preferences, such as user inputs that specify the operation of the stimulation device 1 . The management server 4 can effectively define a user profile server with which user profile data can be synchronised with the management device 2. To this end, the management application 3 configures the management device 2 to receive user credentials for undergoing a log-in exchange with the management server 4. When authenticated via the log-in exchange, information such as the user profile data can be synchronised between the management device 2 and a user-specific account with the management server 4.

[0088] Local data storage 12 may be provided by way of the management application 3 and mobile computing device 2 to facilitate the diary and usage features during periods without connectivity to cloud resource provided by the management server 4. When connectivity to the cloud is re-enabled, offline data held locally on the management device 2 can be synchronised and updated with the cloud database 6 of the management server 4.

[0089] Back-end application functions 5 may be used to manage and configure user accounts and the associated user profile data. User profile data includes stimulation profiles as well as the linking of wearable hardware, such as the stimulation device 1 , to stimulation profiles and user accounts. The stimulation profiles may include, for example, stimulation current intensity, pulse period, frequency, duration, periods of interspaced active and non-active stimulation periods. Parameters in the stimulation profiles may be specific to left or right-handed wearable devices or requirements for wearing a device at other anatomical locations. The parameters may include the frequency characteristics of the stimulation whether it is rhythmic or arrhythmic.

[0090] Machine learning methods and techniques are contemplated within implementations in this disclosure. These may be as part of the machine learning resources 7 provided by the management server 4 that include machine learning models, and the software processes for those machine learning models to be trained and then deployed. These models can be implemented on the management server 4 providing data results through to the web application for display. Alternatively, machine learning models maybe deployed, on the edge directly on the mobile device 2 via the application 3 or on the stimulation device 1.

[0091] It will be understood that, in either case, a variety of machine learning / deep learning methods may be used. The data storage 6 provided in the cloud may comprise training data for machine learning methods. A variety of methods are contemplated including supervised, unsupervised, and semi-supervised methods. Machine learning models being trained to detect and classify, for example, twitching of the thumb once a stimulation threshold has been reached.

[0092] Alternatively, to detect and classify the occurrence of vocal and motor tics, from data acquired either via the mobile application or from sensors on the wearable device or worn elsewhere on the body which have wireless data connectivity to the mobile application. In other implementations user through device controls and app functions can self-report tic occurrences and severity to create annotated sensor data which may be used for machine learning. Symptomatic data either obtained through sensor and / or via self-reported means, along with usage data being used to train predictive model that can advise the user to initiate stimulation or automatically initiate stimulation before the onset of severe symptoms.

[0093] Figure 2 is a schematic block diagram of the management device 2 and management server 4. As described, the mobile application 3 on the management device 2 can connect to a cloud based back-end application and database resource on the management server 4 for functions such as user profile data synchronisation. User profiles and associated user profile data typically originate from the management device 2 which may be configured by the management application 3 to handle more than one user profile.

[0094] In an example implementation, the mobile application 3 can create and manage multiple user profiles 13a, 13b, 13c. The user profiles and associated user profile data comprises a set of specific parameters relating to an individual user, their hardware and stimulation preferences and settings, as well as monitoring data measured by the stimulation device 1, management device 2, other wearable devices (including other stimulation devices), and / or health outcome data entered by the user.

[0095] Linked to a user profile are hardware identifiers 16 relating to wearable devices, such as the stimulation device 1 , used by an individual. Whilst multiple users, for example of a household, may share a stimulation device 1 , the mobile application 3 generally ensures that a stimulation device 1 is exclusively linked to one user profile at a time. This allows multiple users, for example of a family household, to utilise one or more stimulation devices in a convenient and safe manner. User settings and preferences are set correctly, and usage and outcome data obtained from the wearable devices are correctly linked to the assigned user. This is conveniently achieved because the user profile is managed at the management device 2, remote from the wearable stimulation device 1.

[0096] The user profile stimulation parameters 14 may relate to any parameters which specify delivery of transcutaneous electrical stimulation through the wearable stimulation device 1 electrodes 26, 27. These may include, for example, the current intensity of the delivered pulses, stimulation frequency and waveform characteristics such as symmetrical or asymmetrical waveform types. The parameters may also include a specification of whether pulses are delivered in a rhythmic or arrhythmic manner, the pulse period, and duration of stimulation.

[0097] The parameters may also include the characteristics of a stimulation session comprising the sequencing of periods of active and non-active stimulation. Typically, active periods are those periods of time where stimulation is provided through the electrodes, and non-active periods are periods of time where stimulation is not provided. A session may comprise of a sequence of consecutive active and non-active periods with various durations.

[0098] A user profile may also comprise of other related user data 15 relating to outcomes that have been entered by the user, for example with via a health monitoring diary feature. The user data may include the timing, frequency and occurrence data of stimulation sessions that have been triggered by the user on the wearable. This may be combined with adjustments the users may have made directly on the management device 2, or the wearable simulation device 1. Other data may include sensory data, as monitored by sensors on the stimulation device

[0099] 1 , or via other sensors which are wirelessly connected to the stimulation device 1 or management device 2. Of particular use is sensor data that corresponds to the detection of physiological phenomena that is related to the occurrence and severity of tics or other neurological related movement disorders. For example, in one implementation, an inertial measurement unit (IMU) is used to track limb motions and other activities. Machine learning models and other detection algorithms deployed on the wearable stimulation device 1 and / or by the management application 3 can be used to automate the triggering of stimulation based on the detection of user activities such as the presence of vocal and motor tics.

[0100] Also, it has been determined that certain physiological response occur directly prior to tics. Accordingly, it is possible to monitor sensor characteristics which are a precursor to tics, or otherwise indicate an urge to tic. In yet another implementation the machine learning detection and classification algorithms are used to predict stimulation requirements in advance. For example, this may be based on a time-series analysis of sensory data through the detection algorithms.

[0101] A user profile may also comprise of several unique identifiers relating to an article of hardware. An example of this is a Bluetooth® MAC address being a unique 48-bit identifier assigned to each Bluetooth® device. In particular, the MAC address of the Bluetooth® module of the communication interface of the stimulation device 1 can serve as an identifier of the stimulation device 1 for uniquely identifying it to the mobile management application 3.

[0102] In a preferred implementation, the mobile application 3 governs the assignment of hardware, such as an identifier of the stimulation device 1 to a specific user profile mobile. The management application 3 ensures that hardware can only be assigned to one user profile at a time through a linking and unlinking process. A user therefore may be able to use several independent wearable devices which share the same user profile and data information. In Figure

[0103] 2, the example given shows a mobile application 3 configured to manage three user profiles with several assigned devices in each profile. Profile 13a is linked to three wearable devices 1a, 1b, 1c. The second user profile 13b is linked to a single wearable device 1 d, whereas the third user profile 13c is connected to two wearable devices 1e, 1f. At least some of these wearable devices can be in the same form of the stimulation device 1 of Figure 1.

[0104] Figure 3 shows two views - an overhead perspective view, and an underside perspective view - of the stimulation device 1 of Figure 1. The stimulation device 1 comprises a body with an electronics enclosure 20 that encases a rechargeable battery, the communication interface that provides communication to the management device 2, and stimulation control circuitry for providing transcutaneous electrical stimulation through the electrodes 26, 27.

[0105] A control button 21 is formed within the outwardly facing surface of the electronics enclosure 20 with the button 21 arranged to be slightly recessed from the general contour of that surface. This prevents accidental triggering of the button 21 , especially when clothing is worn over the stimulation device 1 . In the present embodiment, the button 21 is used to start and stop electrical stimulation the characteristic of which are specified using the management device 2 and transferred to the stimulation device 1. In order to minimize the risk of erroneously device responses due to inadvertent button actions, predetermined minimum time and / or a defined sequence of timed button depress actions may be implemented to control the device.

[0106] The stimulation device 1 electrodes 26, 27 are positioned such that when the stimulation device 1 is worn as shown in Figure 8 and with the electrodes 26, 27 positioned adjacent to the underside of the wrist, the electrodes 26, 27 can stimulate the median nerve, leading to neuromodulation. Targeting of the ulnar and radian nerve are also contemplated and to considered within the scope of this disclosure.

[0107] The stimulation device 1 ideally has a surface profile around the electrodes 26, 27 that assists with the separation of the electrodes. Additionally, in certain embodiments, the surface profile define seats for detachably attachable hydrogel pads that act as a comfortable and reliable interface between the metal components of the electrodes and the skin of a user.

[0108] In use, the stimulation device 1 is preferably orientated and worn such that the cathode electrode 26 would be proximal to the body (closest to the elbow) and the anode electrode 27 would be distal to the body (closest to the fingers). To this end, the surface of the electronics enclosure 20 is marked or designed with asymmetrical design features to indicate the correct orientation.

[0109] The stimulation device 1 also comprises a wristband having wrist strap portions 22, 23 that can couple to one another, and overlap to a lesser or greater extent to accommodate various sizes of wrists. In certain variations to the present embodiment, the strap portions may be detachable from the enclosure. The wrist band may comprise of multiple sections connectable to both a stimulation device and a smart watch simultaneously. Thereby allowing a smart watch to worn on the upper wrist and a simulation device providing median nerve stimulation on the underside of the wrist.

[0110] The wristband is connected to the enclosure 20 and supports means for personalization to assist device identification and recognition. Specifically, attached to the wristband is a removable identifying device 24 which can be fitted to help users differentiate one device from another. This is intended to aid device identification and recognition, for example, different devices may be differentiated by colour, or using alphanumerical characters.

[0111] In certain variations to the present embodiment, the wrist straps 22, 23 may include an electrical interface which provides connectivity to the electronics enclosure 20. Sensors may be mounted on and within the wristband to measure wrist size, strap tension and other physiological parameters. The sensors may be in the form of a flexi-rigid PCB. Sensors may also be mounted on the underside of the enclosure contacting the skin to measure physiological parameters. The enclosure 20 may include one or more connection port 25 used to provide charging power to the integral battery and / or to interface digitally with external sensors or other wearable devices.

[0112] Figure 4 shows an alternative embodiment of the stimulation device T to that shown in Figure 3. Figure 4 shows two views of the alternative stimulation device T - an overhead view, and a side view. In general, the main principal structures and functions are the same as the stimulation device of Figure 3, and so are denoted in Figure 4 with the same reference numerals.

[0113] The main electronics enclosure 20 has an upper part 20a, and a lower part 20b. The lower part 20b of the enclosure defines a generally flat underside for contact with the wrist. Accordingly, the enclosure is naturally seated at a central position on the wrist when the wristband is tightened around the wrist.

[0114] The upper part 20a of the enclosure comprises a graphical display 29 to provide status and control setting information when in use. An activation control button 21 is used to start and stop stimulation, and two further adjustment control buttons 31, 32 are used to adjust device settings and to enter data. The adjustment control buttons 31, 32 are arranged with markings indicating a direction towards a side of the upper part of the enclosure 20a. The left-hand button 31 points to the left-hand side, and the right-hand-button 32 points towards the right-hand side.

[0115] LED indicators 30, 30a, 30b are provided to provide status information. This may include charging and power status, battery level indication, active and non-active stimulation, fault, or errors modes. The LED indicators 30a, 30b are situated on either side of the electronics enclosure 20a in an arrangement that can advantageously indicate which out of left-hand or righthand stimulation mode has been selected. The left LED 30a can be illuminated for left-hand stimulation, or the right LED 30b can be illuminated for right-hand stimulation.

[0116] The two additional adjustment control buttons 31 and 32 can be used to select left hand or right-hand stimulation mode according to which side button 31 , 32 is depressed.

[0117] In certain implementations of the electronics enclosure 20, a modular construction is envisaged where the electrodes are detachable via a mounting plate which is physically and electrically connected to the control electronics within the enclosure 20. This allows various electrode sizes and geometries, as well as electrode positions and orientations to be implemented through various modular attachments. One way this can be implemented is via the electrode being part of the lower enclosure 20b which is detachable from the upper part of the enclosure 20a.

[0118] For example, electrodes may be positioned slightly to the left or right of the centre line of the enclosure to better target the median and radial nerves which are similarly offset from the centre line of the forearm. Detachable removable electrodes 26 allows convenient means to reorient electrodes according to left- or right-hand wrists stimulation requirements. In particular, the electrodes can be detached, rotated 180 degrees, and reattached to position the electrodes 26 at the appropriate offset for the left or right wrist.

[0119] An example of how electrodes can be reoriented in this way is discussed further below with reference to Figures 19 and 20.

[0120] In addition to setting the appropriate offset for the left or right wrist, it is also desirable to set the stimulation intensity according to left or right-handed selection.

[0121] The applicants have found that the median nerve stimulation required to depolarize the nerve can vary between the left- and right-hand side. It is therefore desirable to be able to select stimulation according to a left hand or right-hand stimulation mode or level. This ensures that stimulation provided is adequate and comfortable depending on which wrist the device is worn on. The present disclosure includes means to select either a left-hand or right-hand mode according to which side the device is worn on.

[0122] One way that this can be implemented in certain embodiments is via the stimulation device 1 detecting repositionable electrode orientation, and automatically selecting the respective left- or right-hand mode of stimulation. In addition, LED indicators provide feedback to a user about the automatically selected mode.

[0123] Other preferred embodiments include means to conveniently select and indicate these sided modes. The mobile app provides a process where the user can set the intensity level for either the left- or right-hand side thereby accounting for anatomical differences between each side.

[0124] The inventors have found that a user's dominant side may typically require a higher intensity level, additionally wrist sizes on the dominant size are slightly larger.

[0125] Sensor data comprising of an I MU (Inertial measuring unit) within the electronics enclosure 20 can track the kinematics and motions of the arm and wrist. Such sensor data can be analysed to determine on which side the stimulation device is being worn as well other inferences.

[0126] This is achieved through machine learning models and detection algorithms. Similarly, the same sensing means and associated detection algorithms on the stimulation and mobile devices can detect common task and activities undertaken by users, such as driving, writing, and typing. The control algorithms governing the devices are thereby able to conveniently select devices on the left or right wrist such that stimulation is provided on the side which least impedes the users' activities and tasks being performed by the hands.

[0127] Figure 5 is a schematic block diagram of electronic control circuitry for the wearable neuromodulation stimulation device 1 of the present embodiments.

[0128] The control circuitry comprises a main processing module 41 , an input-output interface module 42, a power management module 43, a stimulation pulse generation module 45 and an electrode interface 46.

[0129] The control circuitry is powered by a rechargeable battery 50 of the stimulation device 1. A power management module 55 of the stimulation device 1 includes battery charge controllers and a power gauge 43a for battery life monitoring. Power regulators to provide various voltage level power supplies to other parts of the system circuitry are also provided.

[0130] The main processing module 41 is used to provide overall control of the stimulation device 1 including interfacing to the external mobile application 3 and associated host management device 4. An implementation of the main processing module 41 may be in the form of a multicore microprocessor, or a microcontroller running embedded firmware.

[0131] The stimulation device 1 also comprises volatile and non-volatile memory 52 which can be used by the microcontroller and other circuitry components for data storage. Device life cycle and device usage data may be stored in this memory as well as control settings and parameters, for example. The control circuitry may implement a system-on-a-chip architecture and may include other integral sensors 53.

[0132] The control circuitry includes a temperature sensor and an inertial measurement unit (I MU) 53, and a real time clock 54.

[0133] The IMU is configured to perform acceleration measurement, angular rate measurement, and magnetometry. The IMU also comprises data processing means to filter and decompose the kinematic trajectories and motions of the IMU.

[0134] The real time clock 54 may be used to accurately timestamp data or device changes, for example changes to device settings as well as device usage data or any other data recorded.

[0135] The power management module 55 may be used to optimise power consumption, for example switching parts of the system into low power sleep modes when not being used.

[0136] The control circuitry architecture of the stimulation device 1 includes a number of peripheral interfaces to communicate with external devices. An output port 57 is configured for driving indication LEDs, vibration motors, or other output devices. The indication LEDs may indicate device status as well as stimulation modes and status.

[0137] Alternatively, communications protocols such as I2C and SPI may be used to interface with external components such as a graphical LCD display, or other input-output devices such as a microphone, camera or speaker.

[0138] The communications interface comprises a wireless transceiver module 56 that enables communication with external devices such as the management device 2 via, for example, Wi-Fi or Bluetooth low energy connections.

[0139] An output controller 58 of the stimulation device 1 is configured by the main processing module to generate an output control signal. The signal may be a direct representation of the stimulation pattern required prior to amplification or otherwise set a demand level signal to the stimulation pulse generation module 45. The stimulation pulse generation module 45, comprises signal generation and amplification components able to provide variable pulse trains with voltage levels up to 170 volts with current intensities up to 20 milliamps. A preferred embodiment provides pulse trains with 100- 200 microsecond pulses, with frequencies between 3 and 30 Hertz. The pulse generation circuitry can provide monophasic pulse waveforms (single polarity) as well as biphasic asymmetrical and symmetrical waveforms. The preferred embodiment provides a charged balanced waveform avoiding the buildup of electrolytes within the tissue which may arise from extended stimulation with monophasic waveforms.

[0140] Amplification to the required voltage levels may be achieved through several possible electronics topology implementations. These may include voltage step-up transformers, and voltage boost and multiplication circuits 45a.

[0141] Stimulation output can be regulated via a feedback controller 45b. The skin impedance across the electrodes 47, 48, 49, can be variable and so the stimulation control output may be configured to produce a constant current or voltage across the electrodes. Preferably, a constant current is delivered by the electrodes. Advantageously, current regulation, that maintain a constant current, helps ensure that the intensity of stimulation felt by the user stays consistent in spite of changes to skin impedance. Connection to the electrodes may be through a connection port to enable selection of several modular electrode configurations to be connected to the control system.

[0142] A further implementation of the control circuitry further comprises input control components 62 which may include, for example, user input controls such as control buttons / switches or potentiometers. A further implementation of the input control components may include a microphone interface to enable detection of sounds for the purposes of user voice control as well as detection of vocal tics.

[0143] Indicator components 61 such as a graphical interface may be used to provide the user with pertinent device information such as battery level and stimulation session parameters, as well as other usage and measured physiological data or derived data. In certain embodiments, the graphical interface 61 may be in the form of an LED screen.

[0144] The input-output interface module 42 may be used to receive signals from external sensors 60 which may be connected directly via a direct interface port 60b or via a wireless interface 60a such as Bluetooth. These sensors may include, for example, skin moisture, temperature, blood oxygenation, pulse, blood pressure, EMG, galvanic skin response, electrical biofeedback.

[0145] In another preferred embodiment, external sensors are used to monitor the kinematic vibrations of the thumb and fingers. Advantageously, such a sensory input can be used in a feedback control algorithm to set the median nerve stimulation current intensity to a level which is just sufficient to provide a visible thumb twitch or to a level relative to the intensity producing a visible thumb twitch. The sensors are capable of the detection and quantitative analysis of the magnitude of movement and thumb twitch resulting as a response to the median nerve stimulation, and the stimulation device 1 can be configured to set the electrical stimulation levels accordingly. Specifically, the feedback control ensures that the current of the electrical stimulation is neither set too low to be ineffective, such that no thumb twitch occurs, nor too high, where excessive thumb twitch and discomfort occurs.

[0146] Figure 6 is a graph showing an example of the stimulation output during a setup process for stimulation devices according to various embodiments of the present invention.

[0147] The horizontal X axis is time, and the vertical axis is stimulation current intensity in milliamps. In the example shown a pulse train is initiated at 80, the pulse train is then incrementally increased to reach the effective stimulation level. This may be done manually or automatically.

[0148] Advantageously, the increments in current intensity may be of varying magnitudes during the process. In particular, at lower current intensity levels the increment steps may be larger than the increment steps at higher current intensity levels. This promotes a quicker setup process. 71 and 72 for example show these differing adjustment steps.

[0149] In a preferred embodiment of the setup process, the user will be freely available to adjust the current intensity increasing and decreasing the level to the point where a visible thumb twitch just becomes evident. In the example shown, the thumb twitch becomes evident at 73 the user then increases further the stimulation level and then decreases the stimulation level to determine the minimum point where some twitch is visible. When the minimum level of thumb twitch is evident 75 the user then may save that intensity level into the programme memory of the controller. The setup process is then terminated at 81.

[0150] In another preferred embodiment, the stimulation current intensity associated with a visible thumb twitch - also known as "the thumb-twitch intensity level" - is used to define an upper limit of a range of stimulation current intensity effective at alleviating symptoms. The lower limit of the range of stimulation current intensity is typically not below 50% of the thumb-twitch intensity level. The user may adjust the intensity within this effective range 75a.

[0151] Alternatively, the optimum stimulation intensity setting may be determined and indicated relative to the thumb-twitch intensity level. For example, the optimum stimulation 75b may be a preset quantity or a specific percentage lower than the thumb-twitch intensity level, but not below 50% of the thumb-twitch intensity level.

[0152] The range of effective adjustment relative to the twitch intensity level may be indicated via a GUI on the mobile or wearable device. This assisted setup guidance helps ensure the stimulation is not reduced to a level which becomes ineffective.

[0153] It should also be noted that other physiological phenomena instead of thumb twitch (e.g. hand muscle twitch) may be used to define the effective stimulation current range.

[0154] Figure 7 is an example schematic flow diagram illustrating the setup process for stimulation devices according to various embodiments of the present invention. The user will be able to start setup process 80a initiating a stimulation pulse train 82 at a low current setting. A timer function 83 may be used to ensure the setup process and pulse cannot be delivered indefinitely. In a manually adjustable setup process 84, adjustments are achieved through user interaction to either increase 88 or decrease 89 the stimulation current intensity. This is preferably achieved using controls presented by the user interface of the management device 2 running the management application 3. The users through their own sensory and visual feedback 90 whilst receiving stimulation make an assessment as to whether the required stimulation level has been reached.

[0155] In certain embodiments directed to the relief of symptoms associated with Tourettes syndrome, the setup process may comprise prompting a user to input an "urge to tic" rating prior to the application of electrical stimulation, and / or a "tic relief' rating after the application of electrical stimulation. These ratings may be used to determine stimulation characteristics, such as current intensity, or otherwise provide guidance as to how much stimulation characteristics can be altered to provide more effective relief.

[0156] Figure 8 shows an illustration of a stimulation device 1 according to various embodiments worn on the left hand of a user. The stimulation device 1 is activated such that the user receives median nerve stimulation. The user can then observe the extent of thumb, finger or muscle twitch 200 whilst receiving this stimulation.

[0157] Referring back to Figure 7, once the required stimulation level has been reached 91 , 92, the user would then confirm the setting by pressing a control button 85 on the management application 3. This stops the stimulation pulse train 86, reset the setup timing function 83a and save the current intensity parameter to memory 87. This process may be repeated to fine-tune and optimise settings or may be done, for example, for the individual left and right hands.

[0158] In a variation to the process shown in Figure 7, pressing the confirm button 85, defines the upper limit or an optimised adjustment range 75a or is used to calculate an optimum setting 75b relative to the confirmed intensity level.

[0159] Figure 9 is a schematic illustration of the mobile device 2 according to various embodiments, running the management application 3. Under control of the management application 3, the mobile device 2 communicates with the stimulation device 1 to initiate a manual set up process to allow the user to set up the current stimulation levels. As described above, the mobile device 2 comprises a touch-sensitive screen 2a on which can be displayed user-interface (Ul) elements such as those used for remote control of the stimulation device 1.

[0160] Specifically, during the setup process, the management application 3 configures the graphical user interface GUI to instantiate various Ul elements, including: stimulation intensity control Ul elements 88, 89 to increase and decrease the stimulation current respectively; a stop Ul element 95 to stop the stimulation pulse train, and set up process; a confirmation Ul element 85 to confirm / save the settings; a visual stimulation indicator bar 100 showing the extent of available stimulation level adjustments and settings ranges; a stimulation level Ul element 101 positioned along the bar, to indicate the present level of stimulation; a left-hand setting level Ul element 96 to indicate the setting for the left hand; a right-hand setting level Ul element 97 to indicate the setting for the right hand; and a guidance pane 98 to display guidance to a user, including set up and operating guidance.

[0161] Figure 10 is an alternative schematic illustration of the mobile device 2 of Figure 9. In Figure 10, the mobile device 2 is controlled by the management application 3 to communicate with the stimulation device 1 to initiate an automated setup process as an alternative to the manual setup process 84 described in relation to Figure 9. In this case, the management application 3 accesses an inbuilt camera 102 of the mobile device 2. This is used to obtain video images of a user's hand on which the stimulation device 1 is positioned. A view from the field of view of the camera 102 is shown on the screen in a video display pane 99, allowing the user to correctly position and orient the mobile device 2. The video images are automatically processed utilising computer vision or machine learning detection and classification models in order to quantitatively determine the extent of the thumb twitch in real time. A visual indicator bar 98 or other graphical indicating means shown as part of the interface or superimposed on the video may be used to visually indicate the extent of a thumb twitch detection, or the magnitudes of other sensor data relating to the effect of stimulation.

[0162] In this example, the setup process is initiated by the user by pressing control Ul element 200a. Inputs on the mobile device 2, such as the camera, along with computer vision and object detection and classification algorithms may be used to track motions of the hand and fingers in order to be able to quantitatively assess the extent and presence of a thumb, finger and / or muscle twitch which is created through median nerve stimulation.

[0163] The image processing steps may include convolutional filtering, along with custom filters created through selection of an image portion. Tracking movements within the image may be achieved to quantify the magnitudes and hand finger motions. For example, the user would use the indicator 98a showing the magnitude of thumb twitch as a guide to determine an effective stimulation level. When the user is satisfied with the stimulation level the process can be stopped and the current settings saved.

[0164] In another preferred embodiment, guidance can be provided to a user for the optimum positioning of the stimulation device 1 relative to a user's wrist (or another limb). In general, the management device 2 is configured by the management application 3 to detect a position of the stimulation device 1 relative to a part of a body on which the stimulation device 1 is worn and, in response, provide feedback, via the user interface, about how the relative positioning of the stimulation device and the part of the body can be improved to optimise stimulation device efficacy in use.

[0165] Again, this can be achieved using the inbuilt camera of the mobile device 2. Image classification of the hand and fingers may be used to guide the placement of the stimulation device over the peripheral nerves. This is accomplished by detecting and measuring the physical extent of the hand, wrist and lower arm. Graphics to assist placement could then be superimposed on to real-time camera imagery displayed on the screen of the mobile device. This serves to augment the observations of the user (i.e. , via an augmented reality view). For example, the mobile device 2 is configured to show outline targets to assist placement of the stimulation device 1 over the peripheral nerves. Other visual indication means to guide placement may be used, such as arrows and highlighted animation graphics, as relative positioning of the stimulation device 1 and the part of the body on which it is worn deviates from an optimum target location.

[0166] A predetermined nerve location relationship and other anatomical landmarks based on a reference model, scaled anthropometrically, can provide the means to determine target positions. These predetermined models may be references held in a cloud database such the data storage 6 of the management server 4.

[0167] The models themselves may be created using optical scanning and machine learning techniques. To acquire training data for machine learning, or example, three dimensional scans of upper and lower limbs or other relevant body parts may be acquired. Methods of object scanning photogrammetry using a mobile device to acquire 3D models and machine learning techniques to approximate anatomical locations are considered applicable and within scope of this disclosure, including deep learning neural networks, convolutional neural networks, supervised and unsupervised learning methods.

[0168] Machine learning models may be trained using cloud computing resources, such as those deployed by the management server 4, and then deployed on the edge within the mobile device 2 via the management application 3. The models may include detection of specific body parts - for example left- and right-hand identification and individual fingers as well as the movements associated with tics. In certain embodiments, the models may be deployed within the stimulation device 1 , utilising sensors of or connected to the stimulation device 1 to determine where the stimulation device 1 is fitted on the body, and the occurrence of movement tics. The models may also be trained to detect audible tics via a microphone of the management device 2 or other wearables computing devices like smart glasses. In some embodiment, the stimulation device 1 may comprise a microphone for the detection of audible tics.

[0169] Figure 11 is a schematic diagram of an image processing pipeline configured to detect user body movement for use in evaluating tics and / or peripheral nerve stimulation, as applied by the system of embodiments of the present invention. Primarily, the pipeline is generated and refined on the management server 4 utilising cloud-based computing and data storage 6, with trained machine learning models and applications 7. However, a version of the pipeline is transferred from the management server 4 to the management device 2 and implemented on it via the management application 3. Thereby, the management device 2 is provided with the function of detecting user body movement caused by tics and / or peripheral nerve stimulation. Additionally, the management device 2 sends data to the management server 4 to enable continuous refinement of machine learning models and other data processing means implemented on the management server 4.

[0170] The pipeline comprises processing steps that include filtering or other image processing 200 to enhance the detection and tracking of objects of interest. For example, the processing steps may include filters applied to narrow the visible spectrum, convolution filtering to highlight edges or to detect optical patterns. Machine learning objection detection models 205, are preferably generated at the management server 4, but are deployable on the mobile device 2 via the mobile application 3. The detection models 205 may be arranged to, for example, detect specific fingers or anatomical landmarks within the field of view of a camera of the mobile device 2. The models 205 are preferably applied to video images captured by the camera in real-time. Further object classification models 206 are configured to segment the video images to extract specific objects of interest. Segmentation may comprise detecting at least one foreground object, and at least one background object. These objects may then be tracked using an object tracking routine 207 for further analysis. For example, the movement of objects in the foreground can be tracked relative to the background. The kinematic trajectory of detected features and objects within the video, relative to one another, provides the means to assess movements arising out of peripheral nerve stimulation. The object tracking routine 207 generates kinematic signals relating to body movement, particularly oscillatory movement, that can be further analysed using frequency analysis to determine the frequency components within the signal. To this end, a frequency domain analysis module 203 determines frequency components within the signal. Stimulation which is applied at a specific frequency can invoke an oscillatory physical motor response in muscles which has a substantially similar frequency characteristic to the frequency of stimulation which is applied through the electrodes to the peripheral nerves.

[0171] The mobile application 3 may configure the mobile device 2 with a display indictor 201 for displaying outputs from the signal analysis. This helps users optimise settings of the stimulation device 1.

[0172] In a further embodiment, the outputs of these processing steps may provide the inputs to further detection 204 and processing logic 202. For example, the processing pipeline may be able to detect and classify the severity of tics. Detection modules may be deployed on the stimulation device 1 itself for continuously monitoring user activities and being able to log the occurrence of motor and audible tics.

[0173] This data acquisition may be uploaded to the management server 4 whenever the mobile device 2 and the stimulation device 1 are synced, and the mobile device 2 has an Internet connection. In this way data may be captured to develop machine learning models specific to an individual user's tics, and as these change over the course of time, update and change detection models. These processing steps also provide the means to quantify the effectiveness of the neuromodulation provided by the stimulation device 1. The processing steps may also be used as an input to the stimulation setup process - increasing or decreasing the stimulation based on the quantitative analysis provided through the detection models.

[0174] Figure 12 is a schematic diagram of an alternative processing pipeline to that of Figure 11, also configured to detect user body movement for use in evaluating tics and / or peripheral nerve stimulation and subsequent use for optimisation and control. The pipeline uses sensors 60 to augment detection of movements. These sensors may be interfaced wirelessly, or through a wired connection with the mobile device 3, and / or stimulation device 1. Example sensors may include an inertial measurement unit (IMU) with the capability of tracking kinematic motions with 9 degrees of freedom. Specifically, the IMU can detect translation and rotational movements using a combination of accelerometer, magnetometer and gyroscope components.

[0175] Alternatively, there may be sensors mounted on the user's body to pick up the responses from stimulation through muscle electromyography (EMG). Other skin / tissue / nerve sensing transduction modalities are considered within this group. These also include the means to detect heart rate, skin temperature, and impedance. The signal inputs may undergo processing steps 205, for example filtering 205 and frequency domain analysis, for example using a Fast Fourier Transform (FFT). The outputs may be displayed via the display indicator 201 as before. Thresholding detection logic may be applied to provide useful indications to the user through the mobile application 3 on the mobile device 2. For example, a traffic light signal approach (red, amber, green) may indicate the proximity of the current setting to what is considered to be optimal. In another embodiment, the sensory input is combined with the signal processing pipeline is used to provide controlling logic 202 to the setup process. The controlling logic starting or stopping stimulation based on the detection of activities, via the sensors, or an assessment of the response created by the stimulation intensity levels. In this embodiment the process is largely automatic, and the neuromodulation current intensity is determined predominantly by the sensor inputs and the analysis algorithms.

[0176] Figure 13 is a time-series graph showing a kinematic signal corresponding to an output of a point tracked on the thumb when peripheral nerve stimulation, via the stimulation device 1 , is active at a frequency of approximately 10 Hertz. The graph is representative of an example output of a processing step associated with kinematic analysis 208.

[0177] The movements are detected via the detection of changes in image properties, such as pixels corresponding to the tip of the thumb shifting relative to a detected background. Two notable features in the graph are highlighted: region 205 is a motion artefact caused by the hand moving relative to the image frame, and region 206 shows a higher frequency oscillation within the overall motion trajectory.

[0178] Figure 14 is a graph showing the result of a Fast Fourier Transform FFT of the signal of Figure 13. Region 207a indicates that 10-11 Hz is a commonly occurring frequency within the kinematic signal of Figure 13.

[0179] Figure 15 shows two additional variations of the stimulation device 1 according to various embodiments, each being worn on the left hand of user. In each case, external devices are applied to assist an automated setup process akin to that described above in relation to Figure 10. The external device used to augment detection of the required response from stimulation when it is applied. In both illustrations a detectable thumb twitch 200 is the target observation used to set the desired stimulation threshold or to set the upper limit of a range of effective settings.

[0180] In the first shown variation, optical hand markers attached to the user's hand are used to assist in the tracking of hand motions. A first marker 99a is attached to a palm region of the hand, and a second marker 99b is attached to the tip of the thumb. One or more background optical markers 99c may be applied to a background surfaces. These markers maybe of specific colours shapes or patterns which are more readily detectable through computer vision filtering algorithms. For example, they may be of a specific colour, ideally contrasting with natural skin tones. Optical filtering can then remove unwanted data from the imagery, simplifying the tracking and detection process. In certain variations, the markers may be reflective of infrared light, be specifically colour-coded, and / or have detectable patterns such as QR codes. The added markers can be motion tracked within the imagery. Movement artefacts which are not of specific interest in relation to stimulation settings may be removed through comparison of motion trajectories mounted on the body and anatomical landmarks relative to markers mounted on the background frame of reference.

[0181] In the second variation shown in Figure 15, a movement detection component 600 forms an extension to the stimulation device 1. The movement detection component 600 comprises a fitment portion in the form of an elasticated loop 600a for fitting to the end of the thumb of a user, and an inertial measurement unit (IMU) sensor 60. The kinematic outputs from the IMU and associated filtering can be used to track thumb motions relative to the wrist-mounted wearable stimulation device 1 . The detection component 600 further comprises a direct wired data and power connection 600b for connecting to the stimulation device 1 , such that the I U can draw power from the stimulation device 1 , and transfer movement data to it. Other external sensors 60 may be used, as discussed above, and may be connected directly for power and data exchange with one or more stimulation devices 1 in the same way as the movement detection component of Figure 15. In further alternatives, external sensors 60 may instead have their own standalone power supply and communicate wirelessly with the one or more stimulation devices 1.

[0182] Figure 16 includes two schematic views, each of the mobile device 2, according to various embodiments of the present invention configured to interface with several stimulation devices 1a, 1b, 1c, 1d, each also according to various embodiments of the present invention. Moreover, and as referred to above, the management application 3 configures the mobile device 2 to coordinate and control two or more wearable stimulation devices 1a, 1 b, 1c, 1d, to be worn simultaneously by the same user at different locations on their body.

[0183] For example, in the case of stimulation devices 1a, 1b, 1c, 1d intended for median nerve stimulation, such devices may be worn on either or both hands. Due to hand dominance, it may be desirable to initially provide stimulation via a dominant side, and then switch stimulation to the non-dominant side automatically as a dominant hand begins to perform tasks.

[0184] Sensors within the electronics enclosure 20 of each stimulation device 1a, 1b, 1c, 1d are used to quantify and characterize the activity being performed. Control logic is then used to selectively switch to the non-dominant side so as not to impede the function of the hand and fingers during dominant hand critical tasks, such as writing and typing. This may be achieved by further machine learning models deployed on the wearable devices or other detection algorithms used to quantify and threshold levels of activity. For example, when very fine repetitive motions are detected, this may indicate typing or writing.

[0185] The simultaneous use of multiple neuromodulation devices 1a, 1b, 1c, 1d worn at other body locations is considered within the scope of this disclosure. This may include, for example, devices worn on the upper limbs and lower limbs, trunk, or head. Furthermore, it may be desirable to provide stimulation with different characteristics (e.g., at different frequencies) to target the therapy for different neurological conditions and disorders.

[0186] This may extend to applications of physical rehabilitation in the case of nerve injuries and impairments. The simultaneous use of more than one neuromodulation device 1a, 1b, 1c, 1d enables peripheral nerve stimulation at a multitude of different frequencies and different rhythmic patterns. The stimulation provided from a stimulation system incorporating multiple devices 1a, 1b, 1c, 1d may be coordinated to start / stop, change frequency or rhythmic pattern on the detection of certain conditions. Detection of activities could include specific activities through detection classification models, for example adopting machine learning and deployment techniques. Models could be trained to detect specific actions on activities such as playing instruments, writing, typing or other characteristic task and body motions. This may be combined with a wider data acquisition and activity analysis which includes physiological measures such as heart rate, oxygen consumption. Sensor data from the stimulation devices 1a, 1b, 1c, 1d, other wearables and the mobile device 2 along with historical data records may input into algorithms and reference thresholds to provide control logic.

[0187] The first view shown in Figure 16 schematically represents a system having multiple neuromodulation devices 1a, 1b, 1c, 1d having wireless connection capability to the mobile device 2 as configured by the mobile application 3. In this view, there is no interconnectivity between neuromodulation devices 1a, 1b, 1c, 1d.

[0188] The second view shown in Figure 16 schematically represents the same system as the first, but wherein the neuromodulation devices 1a, 1b, 1c, 1d can communicate with one another (as well as to the mobile device 2). In this version, one of the neuromodulation devices 1a may be assigned the role of master where the other neuromodulation devices 1b, 1c, 1d receive command control information from the master neuromodulation device 1a.

[0189] The master device and / or the individual neuromodulation devices may also be interconnected and coordinated through the mobile device 2.

[0190] Ultimately, whether the neuromodulation devices 1a, 1b, 1c, 1d are connected directly to one another, or do so via the mobile device 2, they have the capability to exchange data and control information for the purposes of stimulation activity control where the actions performed by one neuromodulation device are dependent on monitoring the actions of others. Moreover, the activity of the neuromodulation devices 1a, 1b, 1c, 1d can be monitored and controlled via instruction sets that can be conditional on the behaviour of one another.

[0191] Figure 17 is a schematic view of an example implementation of an instruction set, expressed as a table, for the group of interoperable neuromodulation devices 1a, 1 b, 1c, 1d, (also identified as DA1 , DA2, DA3, DA4 respectively) shown in Figure 16. The instruction set is dependent on receiving information from an activity monitoring pathway 305, typically implemented via activity communications between the devices 1a, 1 b, 1c, 1d.

[0192] In certain embodiments, the instruction set is distributed across the stimulation devices 1a, 1b, 1c, 1d and the mobile device 2, each storing and executing a relevant part of the instruction set.

[0193] The instruction set table establishes a relationship between a device 1x (column 1), how it is synchronised or otherwise coordinated with other devices 301 (column 2), the frequency of stimulation in Hertz when that device is active 302 (column 3), the pattern of stimulation 303 (column 4), and how the activation of the device is dependent on a detected activity or condition of a user 304 (column 5).

[0194] By way of illustrative, non-limiting example, the instruction set specifies that:

[0195] Device DA1 starts stimulation activity at the same time as DA2 plus a time delay (ds), with a stimulation frequency of 10Hz, in a rhythmic pattern, but stimulation is excluded if activity A1 (e.g. a user driving a car) is detected;

[0196] Device DA2 starts stimulation activity if DA1 is active, with a stimulation frequency of 12Hz, in an arrhythmic pattern, with no user activity dependencies;

[0197] Device DA3 starts stimulation activity exclusively when no other devices are activated, with a stimulation frequency of 12Hz, for a predetermined period at scheduled times of the day, and is triggered by user activity A2 (e.g., high stress levels); and

[0198] Device DA4 starts stimulation activity when DA3 finishes its first stimulation period such that DA3 and DA4 alternate stimulation activity (i.e., when DA3 is on, DA4 is off, and vice-versa). DA4 applies a stimulation frequency of 15Hz, in a rhythmic pattern, with no explicit user activity dependencies. However, as device DA4 follows the activation of DA3 in response to user activity A2, it is implicitly dependent on activity A2.

[0199] Natural variations to these behaviours and instructions are contemplated within the scope of the present embodiment. For example, the stimulation frequencies may be the same, or may different between devices. The stimulation patterns maybe rhythmic or arrhythmic. The order of stimulation may be programmed to be initiated at specific times of the day. The control logic may also consider a variety of activities and conditions as a positive or negative input. For example, when certain activities are detected, stimulation via a specified device may be prohibited.

[0200] Figure 18 shows a view of two stimulation devices 1a, 1b, worn simultaneously by user on the left and right wrist respectively, providing coordinated median nerve stimulation. Each are connected in the manner as described above, with controlling logic to selectively switch stimulation modes and types between hands. The LED indicators on the wrist-mounted stimulation devices 30a, 30b, indicating which is active. Other LED indicators may indicate the mode of stimulation.

[0201] Figure 19 shows three views of a further example variation of the stimulation device according to various embodiments of the present invention. The stimulation device 1g of this variation is arranged to provide targeted stimulation of nerves, such as the median, radial, and ulnar nerves, below the wrist. This is achieved by allowing a user to vary the position of the electrodes 47, 48 to accommodate the offset of those nerves from a central position along the arm.

[0202] This cannot be achieved by simply wearing the device upside down, as it has been determined that the relative positioning of the positive and negative electrodes (anode and cathode) is important to achieve a desirable stimulation effect and so must be maintained rather than switched around. As described above, preferably the cathode electrode 48 should be proximal to the body (closest to the elbow) and the anode electrode 47 would be distal to the body (closest to the fingers).

[0203] Thus, to target the radial nerve having a less centralised position for example, the offset position needs to be sided according to the left or right hand. This means that differing offset positions would be required for the left and right hand whilst maintaining the correct polarity of the electrodes.

[0204] To overcome this problem, the stimulation device 1g comprises an electrode interface adapter configured to allow modular attachment of a left-hand or right-hand electrode interface piece 400.

[0205] It should be noted that a multipurpose electrode interface piece 400 may serve as both a left-hand and right-hand electrode interface piece 400 depending on the orientation with which it is attached to the electrode interface adapter. To this end, such a multipurpose electrode interface piece 400 and the electrode interface adapter have complementary connectors to allow left- or right-hand connection orientations.

[0206] The first view shown in Figure 19 is of an underside of the stimulation device 1g fitted with a right-hand electrode interface piece 400. The interface piece 400 is also shown in the first view from the rear. When fitted, electrode contact with the wrist of a user is at an offset towards a thumb side of the wrist.

[0207] The second view shown in Figure 19 is of an underside of the stimulation device 1g fitted with a centrally-aligned electrode interface piece 400a. The third view shown in Figure 19 is of an underside of the stimulation device 1 fitted with a left-hand electrode interface piece 400b.

[0208] In each case, the piece 400, 400a, 400b is in the form of a slidably attachable plate that can be slid into a channel 401 formed in the underside of the enclosure 20 of the stimulation device 1g. The sliding direction to attach the piece is indicated in the third view of Figure 19 by a large arrow. The channel 401 comprises a constraining abutment 402 against which the piece abuts when fitted, as shown by the dashed line in the third view of Figure 19. The electrode interface adapter and the electrode interface piece have complementary locking formations that interact with one another to lock the piece into place, also thereby ensuring the reliability of the electrical connection from the electrical signal generator within the enclosure, via the complementary connectors of the electrode interface piece 400 and the electrode interface adapter, to the electrodes.

[0209] The user can select and fit a left-hand or right-hand electrode interface piece 400 depending on their requirements, and in doing so, the polarity of the electrodes is correctly set.

[0210] This helps overcome the complexity where the user would have to correctly orient cathode and anode electrodes according to polarity as well as ensure sidedness position of the electrodes is correct according to the wrist the stimulation device 1g is being worn on. The electrode interface piece 400 and the adapter are configured such that selecting an appropriate position of the electrodes inherently results in the correct polarity setting.

[0211] A further advantage of this approach is that different electrode patterns and shapes may be interchangeably fitted to neuromodulation devices.

[0212] The electrode mounting interface piece 400, may be electrically connected using malefemale electrical connection sockets, or through spring loaded electrical connections.

[0213] Figure 20 is a partial side view of the stimulation device 1g of Figure 19 fitted with the electrode interface piece 400b. The electrode interface piece 400b comprises a plate having bevelled edges 408 that are narrower towards the outwardly facing surface of the piece 400b. This cooperates with a complementarily-angled slot into which the plate is slidably fitted such that the plate is retained in place once so fitted. Variations of the slidable and detachable electrode plates are to be considered within the scope of this disclosure. This includes variations in electrode materials, patterns, positions, sizes and shapes. Through an electric connection to the plate, the plate may also contain other sensors in contact with the skin. Referring back to the second view of Figure 19, the electrode interface pieces may each have a surface profile that assists with the electrical separation of the anode and cathode, and furthermore including seats for conductive pads which may be made from hydrogel 403. For example, referring to the second view of Figure 19, a raised central region 405 of the surface profile between the anode 47 and cathode 48 ensures separation and furthermore defines part of the recessed seat into which conductive hydrogel pads 403 are received. The surface profile around the metal part of the electrodes is countersunk by an amount that, when the hydrogel pad is fitted, brings the skinfacing surface of the gel pad that is fitted into the seat approximately level with, or slightly above the surrounding surface profile, such as that of the raised central region. Additionally, the electrode surfaces may have surface profiling 48b to add to the contact surface area to provide friction and added adhesion effect to the fitted conductive hydrogel pads.

[0214] Figure 21 shows another electrode interface piece 400c compatible with the stimulation device of Figure 20. The electrode interface pieces 400c comprises a pair of linear grooves 406 within each of which a respective electrode 47, 48 is slidable. This is achieved via each electrode sliding along a respective conductive track extending along each groove, each conductive track being connected to the electrical stimulation circuitry within the device 1g.

[0215] In the present embodiment, friction between each moveable electrode and its track is sufficient to keep the electrode at a user-selected position. In alternatives, other electrode position control mechanisms may be used, such as a detent / ratchet mechanism. Additionally, arrangements with more than two electrodes may be provided in alternative embodiments. For example, moveable electrical electrode positions may be used to switch between the targeting of the median radial and ulnar nerves of each of the left and right hand. When connected to the electrode interface adapter, the electrode interface piece 400c effectively becomes part of the underside of the enclosure 20b of the stimulation device 1g. In alternatives, the moveable electrodes 47, 48 and grooves 406 may be integrated with the underside of the enclosure 20b. That is, provision of the moveable electrodes need not necessarily rely on the use of an electrode interface piece 400c.

[0216] Figure 22 shows a side view of the enclosure 20 and the wristband 22, 23 of a stimulation device 1 according to a further embodiment of the present invention. The enclosure 20 and wristband 22, 23 are shown to be separated from one another to illustrate that they have complementary electrical connectors 60b, 60c that electrically interconnect when the enclosure 20 and wristband are physically interconnected. The connectors 60b, 60c may be spring-loaded ball connectors, or other suitable mating connectors, which facilitates an electrical connection that is resilient to slight relative movements between the connectors as may result from flexing of the wristband during use.

[0217] This connection provides the power and data interface connectivity to a sensor 60 that is external to the enclosure 20. The sensor 60 is embedded at another location on the wrist strap 23 to that of the electrical connector 60c. External sensors of various types are contemplated within the scope of this disclosure which may, for example, be able to measure wristband strain (and thus band tightness), contact surface pressure and temperature. Electrical, magnetic and optical transduction techniques may be applied by such sensors to measure physiological characteristics of a user's skin or body tissue.

[0218] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations.

Claims

CLAIMS1. A therapeutic electrical stimulation system, the system comprising a wearable nerve stimulation device, a management application, and a management device configured to execute the management application: the stimulation device comprising a communication interface, and an electrode assembly for delivering a sequence of electric signals to nerves of a user wearing the device; the management device comprising a user interface and a communication module, the management device being configured by the management application to: receive at least one user input, via the user interface, for specifying the operation of the stimulation device, and converting the at least one user input into a set of instructions; and connect, via the communication module, with the communication interface of the stimulation device, and transfer the set of instructions to the stimulation device; the stimulation device being configured by the set of instructions received from the management device to deliver a sequence of electrical signals, via the electrode assembly, in accordance with the at least one user input.

2. The system of any preceding claim, wherein the management device is a portable management device, such as a smartphone, configured to download the management application from an application server.

3. The system of any preceding claim, wherein the management device is configured to display, via the user interface, a user selection prompt, the prompt being configured to receive an input to select an identity of a selected user of the stimulation device, and in response access user profile data, associated with the selected user, for use in specifying the operation of the stimulation device.

4. The system of claim 3, wherein the management device communicates with the stimulation device to specify that the selected user is the active user, the stimulation device being configured for operation exclusively linked to the user profile data of the active user.

5. The system of claim 4, wherein the management device and / or the stimulation device is configured to persistently display, via the user interface, a user identifier associated with the active user selected via the user selection prompt, thereby guiding against misuse by one user of another user's settings.

6. The system of claim 4 or claim 5, wherein the management device is configured to store usage data, such as time and duration of manual activation of the stimulation device, within the user profile data associated with the selected active user.

7. The system of any preceding claim, wherein the stimulation device comprises a user selection interface, the user selection interface being configured to receive an input to select between multiple users of the stimulation device, and in response access user profile data, associated with the selected user.

8. The system of any preceding claim, wherein at least one of the stimulation device and the management device is configured to display a user identifier associated with the active user selected via at least one of the user selection interface of the stimulation device, and the user selection prompt of the management device.

9. The system of any preceding claim, wherein the stimulation device and the management device communicate to transfer user profile data between one another.

10. The system of claim 9, wherein the user profile data includes at least one optimal setting for that user, as stored during a setup process.11 . The system of any preceding claim, wherein the system comprises a user profile server, the management application configuring the management device to receive user credentials, and in response synchronise user profile data with the user profile server;wherein the user profile data comprises the at least one user input for specifying the operation of the stimulation device.

12. The system of claim 11 , wherein the user profile data comprises at least one of: usage data, and user-specified parameters.

13. The system according to any preceding claim, wherein the at least one user input is operable by a user to specify at least one of: a usage parameter, such as the location of the body that the stimulation device will be worn; an intensity of the electrical signals for nerve stimulation; and a pattern of the sequence of electrical signals for nerve stimulation.

14. The system according to any preceding claim, wherein the management device is configured by the management application to enact a set-up process to customise the operation of the stimulation device for a user, the set-up process comprising at least one of: a manual set-up process and an automated set-up process.

15. The system according to claim 14, wherein the setup process comprises displaying, on the user interface of the management device, guidance for optimising the operation of the stimulation device for a respective user.

16. The system according to claim 14 or claim 15, wherein the setup process comprises displaying, on the user interface of the management device, a set of user-interactable elements configured to receive a sequence of user inputs to iteratively tune the operation of the stimulation device towards an optimal setting for that respective user.

17. The system according to claim 16, wherein iteratively tuning comprises alteration of an intensity of the electrical signals.

18. The system according to claim 16 or claim 17, wherein the optimal setting for that respective user is stored within user profile data associated with that user.

19. The system according to any one of claims 14 to 18, wherein the setup process comprises displaying, on the user interface of the management device, a prompt to increase the intensity of the electrical signals until a physiological phenomenon, such as a thumb twitch, can be observed or felt by the user.

20. The system according to claim 19, wherein the optimal setting is set as an intensity that is between 65% and 95% below that which that causes the physiological phenomenon.21 . The system according to any one of claims 14 to 20, wherein an automated setup process comprises at least one of: displaying, on the user interface of the management device, guidance to position a sensor of the management device, such as a camera, relative to a part of the user's body; automatically recognising correct positioning of the sensor relative to the part of the user's body; automatically starting the iterative tuning of the operation of the stimulation device; monitoring the part of the user's body via the sensor, during the iterative tuning, to detect a physiological phenomenon indicating an optimal setting; and determining and storing the optimal setting for a respective user against their user profile data.

22. The system according to claim 21, wherein the sensor is a camera, and the management device applies automatic image recognition of the part of the user's body for positioning and monitoring.

23. The system according to claim 21 or claim 22, wherein the setup process comprises displaying, on the user interface of the management device, guidance for optimising the position of the sensor, issued in response to detecting a suboptimal positioning of the sensor relative to the user body part.

24. The system according to any one of claims 14 to 23 wherein the set-up process comprises at least one of: receiving a user input to specify a part of the body on whichthe stimulation device is worn for the set-up process; and automatically detecting a part of the body on which the stimulation device is worn for the set-up process.

25. The system according to any one of claims 14 to 24, wherein the set-up process comprises: guidance, displayed via the user interface of the management device, for guiding a user to operate the management device to obtain an optimal stimulation setting; and saving of the optimal stimulation setting on at least one of: the stimulation device and the management device, for use during a therapeutic activation of the stimulation device.

26. The system according to any one of claims 14 to 25, wherein the set-up process comprises a manual set-up process in which: the user interface of the management device provides at least one user input for controlling stimulation intensity, user interaction with that at least one user input being communicated from the management device to the stimulation device for respective control of electrical signal intensity; and the user interface of the management device provides a saving means, such as a user input, for saving an optimum stimulation intensity.

27. The system according to any one of claims 14 to 26, wherein the set-up process comprises an automated set-up process in which: the stimulation device is activated to perform a range of electrical stimulation; the management device is configured to receive physiological response information dependent on a user body response to the range of electrical stimulation from the stimulation device; the physiological response information is processed to determine a threshold condition with which an optimum stimulation intensity is associated; and the optimum stimulation intensity is determined and saved.

28. The system according to claim 27, wherein processing of the physiological response information comprises applying a classifier function, such as a neural network trained to detect the threshold condition with which an optimum stimulation intensity is associated.

29. The system according to claim 27 or claim 28, wherein the physiological response information comprises images of a part of the user body influenced by the range of electrical stimulation, and the classifier function comprises applying an image classifier.

30. The system according to any preceding claim, wherein the management device is configured by the management application to detect a position of the stimulation device relative to a part of a body on which the stimulation device is worn and, in response, provide feedback, via the user interface, about how the relative positioning of the stimulation device and the part of the body can be improved to optimise stimulation device efficacy in use.31 . The system of claim 30, wherein the management device comprises a camera configured by the management application for use in detecting the position of the stimulation device relative to the part of a body on which the stimulation device is worn.

32. The system of any preceding claim, wherein the stimulation device comprises at least one sensor for determining a location of the body at which the stimulation device is worn, and wherein at least one of:- the intensity of the electrical signals for nerve stimulation; and- the pattern of the sequence of electrical signals for nerve stimulation; are automatically selected by the stimulation device in dependence on the determined location of the stimulation device.

33. The system of claim 32, wherein the at least one sensor comprises an inertial measurement unit (IMU).

34. The system of any preceding claim, wherein the stimulation device is configured to be wrist-worn, so that the electrode assembly is positioned against the underside of a wrist of a user, adjacent to and arranged to stimulate at least one of a median nerve, an ulnar nerve and radian nerve of the user, via transcutaneous electrical stimulation.

35. The system of any preceding claim, wherein the electrode assembly comprises a pair of conductive pads, for promoting comfortable and reliable electrode-to-skin contact.

36. The system of claim 35, wherein the pads having a skin-facing surface that grips the skin.

37. The system of claim 35 or claim 36, wherein the stimulation device comprises an underside surface for contacting with a user's skin in use, the electrode assembly having a pair of contacts that are set into the underside surface and the pair conductive pads are detachably attachable to a respective contact.

38. The system of claim 37, wherein the underside surface is contoured in the region of the contacts to define a pair of recesses for accommodating the respective pair of conductive pads so that a skin facing surface of the pads is at least one of: substantially level with and slightly raised from a peripheral region of the underside surface around the contacts.

39. The system of any preceding claim wherein the stimulation device comprises a body for housing at least a power supply, the electrode assembly being repositionable relative to the body to allow electrode location customisation.

40. The system of claim 39, wherein the electrodes are repositionable between a left-hand and right-hand configuration.41 . The system of claim 39 or claim 40, wherein each electrode is moveable along a respective track, the tracks extending transverse to a body part to which the stimulation device is attached in use.

42. The system of any preceding claim, wherein the electrode assembly comprises an electrode interface adapter configured to allow modular attachment one or more electrode interface pieces.

43. The system of claim 42, wherein the one or more electrode interface pieces comprise plates that are configured to slide relative to the electrode interface adapter to attach and detach therefrom.

44. The system of any preceding claim, wherein the stimulation device comprises indicia for indicating which way the device should be oriented, depending on which body part the device is to be worn.

45. The system of any preceding claim, wherein the stimulation device comprises controls for user-control of the operation of the stimulation device, the controls comprising at least one of: an activation switch for switching the device between an active configuration in which electric signals are delivered via the electrode assembly, and a passive configuration in which the electrode assembly is deactivated; and mode selectors for selecting a mode of electrical signal delivery.

46. The system of any preceding claim, wherein the stimulation device comprises at least one status indicator for indicating to a user:- a location of the body that the device is intended to be worn;- a mode of electrical signal delivery; and- a status of a power supply.

47. The system of any preceding claim, wherein the stimulation device is configured to receive tic data, and deliver the sequence of electrical signals in dependence on the tic data; wherein the tic data comprises a determination of the occurrence and intensity of at least one of a: user vocal tic and a user physical tic.

48. The system of claim 47, wherein the sequence of electrical signals are delivered in dependence on the tic data in a feedback loop to minimise the intensity of the at least one user vocal tic and a user physical tic.

49. The system of claim 47 or claim 48, wherein the stimulation device comprises, or is connected to, a microphone for the detection and determination of a user vocal tic.

50. The system of any one of claims 47 to 49, wherein the stimulation device comprises, or is connected to, a movement sensor for the detection and determination of a user physical tic.51 . The system of any preceding claim, wherein the stimulation device is configured to receive tic data, and deliver the sequence of electrical signals in dependence on the tic data in combination with response data, the response data being generated by measuring user manual activation of the stimulation device to deliver electrical signals following a tic.

52. The system of any preceding claim, wherein the stimulation device comprises a power supply and a power supply management module configured to: monitor the power supply, and transmit power supply information to the management device, the management device being configured to display the power supply information via the user interface; and / or monitor usage of the stimulation device, and switch the stimulation device between a low-power state and a normal state in dependence on whether the device is being worn and / or actively used.

53. The system of claim 52, wherein the power supply of the stimulation device is rechargeable, and the stimulation device further comprises a recharge port via which the power supply is connectable to an external power source for recharging.

54. The system of any preceding claim, wherein the stimulation device comprises a detachably attachable identifier, having indicia for personalising the stimulation device.

55. The system of any preceding claim, wherein the sequence of electrical signals delivered by the electrode assembly of the stimulation device are characterised by at least one of: voltages up to 170 volts; currents up to 20 milliamps; at least one pulse train having 100-200 microsecond pulses; at least one pulse train having a frequency between 3-30 Hertz; and a waveform that is substantially charge balanced.

56. The system of any preceding claim, wherein the stimulation device comprises a stimulation feedback controller for regulating at least one of the current and the voltage at a stable level.

57. The system of any preceding claim, wherein the system comprises a plurality of nerve stimulation devices wearable by a common user, each configured to communicate so that they can deliver electric signals that are coordinated with one another to the nerves of the common user.

58. The system of claim 57, wherein, the system comprises a body use detector for detecting use of a part of a user body on which at least one of the plurality of nerve stimulation devices are worn, the delivery of electric signals by the plurality of nerve stimulation devices being controlled in response to the detected use of a body part by the body use detector.

59. The system of claim 58, wherein the detected use comprises detection of fine motor skills, such as writing or typing.

60. A stimulation device or a management device of the system of any preceding claim.

61. A method of therapeutic electrical nerve stimulation, comprising: executing a management application on a management device; receiving at least one user input for specifying the operation of a stimulation device, and converting the at least one user input into a set of instructions; transmitting the set of instructions from the management device to a stimulation device for configuring the stimulation device to deliver electrical signals in accordance with the at least one user input.

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