Galvanic and electromagnetic stimulator miniaturized by microfabrication

Abstract

The invention relates to a stimulation module combining galvanic and electromagnetic stimulation, consisting of a housing having: • two electrodes positioned to come into contact with the mastoids of the user and connected to a source of electric current, one of the electrodes being active, the other of the electrodes being passive • at least one electromagnetic coil for generating electromagnetic stimulation without contact, formed on an electrically insulating substrate, the substrate being associated with a heat sink • two separate compartments for housing, on the one hand, the electrical stimulation circuit connected to the electrodes and, on the other hand, the electromagnetic stimulation circuit supplying the coil • an electronic control circuit for controlling the sequences of electrical and electromagnetic stimulation, including a Bluetooth module for receiving remote control signals of the stimulation parameters.

Description

Miniaturized galvanic and electromagnetic stimulator produced by microfabrication Scope of the invention

[0001] The present invention relates to the field of galvanic and electromagnetic stimulation devices for treating various vestibular and neurological disorders. These devices are designed to provide therapeutic stimulation through miniaturized electrodes and coils attached to the mastoid process (the area behind the ears). These electrodes deliver electrical and electromagnetic signals intended to rehabilitate or stabilize balance, alleviate neurodegenerative symptoms, or enhance immersion in virtual environments.

[0002] These devices are used, in particular, to treat vestibular disorders, pathologies affecting balance, such as Ménière's disease, chronic vertigo, and other dysfunctions of the vestibular system. They are also used for the rehabilitation of patients suffering from brain injuries, concussions, or other neurodegenerative diseases such as Parkinson's disease. These patients can benefit from stimulation to improve their perception of balance or reduce associated symptoms. Finally, electromagnetic and galvanic stimulation can also be used to synchronize sensory signals with immersive experiences, such as virtual reality (VR), and to prevent or reduce symptoms of disorientation.

[0003] Thus, these devices find applications in health systems, portable rehabilitation devices and even in wellness or sensory training uses via miniaturized electronic devices.

[0004] State-of-the-art galvanic and electromagnetic stimulation devices stimulate the nervous system using low-intensity electric currents or electromagnetic fields applied to specific areas of the body, particularly around the ears and head.

[0005] Vestibular galvanic stimulation uses electrodes placed behind the ears to send low-intensity direct currents through the mastoid muscles. The electrical current temporarily alters how the brain interprets balance signals from the semicircular canals in the inner ear. It is used for the rehabilitation of patients with vertigo, balance disorders, or disorientation. It is also being explored to improve posture and stability.

[0006] Some devices use helmet-mounted electrodes for non-invasive skin stimulation, synchronized with other systems to adjust signals according to body movements.

[0007] Electromagnetic stimulation uses coils to generate magnetic fields near the mastoids, inducing non-contact stimulation of the underlying nerve tissue. The magnetic field penetrates the tissue and influences neurons in the stimulated area. Electromagnetic stimulation is often used in conjunction with electrical stimulation, allowing for more precise interaction with nerve structures.

[0008] In addition to the treatment of vestibular disorders, this technique is used for neurological rehabilitation, for example in patients who have suffered brain injuries.

[0009] Some devices integrate both types of stimulation, such as galvanic and electromagnetic stimulators (GVS / GEMS), and include control modules to adjust stimulation parameters in real time. They may include motion sensors (IMU) to synchronize stimulation with the user's movements and thus optimize the therapeutic effect.

[0010] The electrodes for GVS deliver controlled currents, while the electromagnetic coils generate fields for gentler, non-invasive stimulation. These devices are equipped with embedded computer systems to monitor and adjust the stimuli according to individual needs and data collected on the patient's condition.

[0011] Some recent devices include motion sensors such as accelerometers and gyroscopes to track head movements and adjust stimulation accordingly. Some devices also capture physiological data, such as brain or muscle activity, to personalize stimulation in real time.

[0012] Users can adjust stimulation levels from mobile applications or specific software, allowing for the personalization of therapies according to preferences or medical recommendations.

[0013] Current devices use wireless induction charging and are encased in biocompatible materials such as silicone for extended use without discomfort or skin reaction. State of the art

[0014] Prior art includes application WO 2023 / 176924, which describes a transcranial stimulation device combining galvanic and electromagnetic stimulation. This prior art device comprises a stimulation module designed to deliver a current via two electrodes placed on the head (particularly near the ears), and a magnet (electromagnetic or permanent) cooperating with a pulsed current source to locally modify the path of the intracranial current by the Lorentz effect. The magnetic field configuration allows the current trajectory in the brain to be modulated to target specific functional areas. WO 2023 / 176924 envisions several pairs distributed across the scalp. The aim is to improve the focusing of electrical stimulation in neurological or vestibular treatments, particularly in outpatient settings.Furthermore, the control of the device is purely internal or local; the control circuit is embedded in the casing, without opening to the outside via a radio protocol.

[0015] US patent 2013 / 0150653 describes a non-invasive electromagnetic stimulation device for modulating neural functions in the ear region. The system uses one or more electromagnetic coils (EM coils) arranged near neural structures, including the vagus nerve, the Gasserian ganglion, and other periauricular areas. The coils are combined with a power pack, an energy regulation system, sensors, and a signal generator, all integrated into a portable module. The goal is to generate focused electromagnetic fields to stimulate or inhibit specific nerve areas without physical contact. The system can be anatomically adapted to different user profiles, but it does not include galvanic stimulation, remote control, or a housing that integrates all control and heat dissipation functions.

[0016] US patent application 2024 / 0226553 describes a portable neuromodulation device that applies low-intensity electrical currents through the skin using two electrodes. It aims to improve alertness, cognition, or athletic performance through transcranial direct current stimulation (tDCS). This prior art device is housed in an ergonomic casing and includes flexible electrodes, a microcontroller, a rechargeable battery, and a Bluetooth interface for adjusting parameters via a mobile application. The shape and positioning of the electrodes are adjustable.

[0017] US patent 11,324,916 describes a portable neuromodulation system designed to apply electrical currents through the skin (tDCS or transcutaneous electrical nerve stimulation) using flexible electrodes placed on the scalp or other areas. The system includes an integrated control module, a Bluetooth interface for remote control, and safety algorithms to prevent overstimulation.

[0018] US2019 / 0046794 describes a portable neurostimulation device using an electromagnetic coil to deliver non-invasive transcutaneous stimulation to cranial nerves, including the vagus nerve. Stimulation is produced via contactless magnetic induction from one or more coils integrated into a flexible support. The system includes a microcontroller, a data storage and processing module, and a wireless (Bluetooth) user interface. Disadvantage of prior art

[0019] Previous solutions are poorly suited for user-friendly applications and require expert intervention for placement on the patient's skull. Furthermore, the positioning of the multiple electrodes is delicate and sometimes leads to faulty contact, preventing the correct application of GVS stimulation signals. Solution provided by the invention

[0020] To overcome these drawbacks, the invention relates to a stimulation module combining galvanic and electromagnetic stimulation, consisting of a housing comprising: two electrodes precisely positioned to come into contact with the user's mastoids, connected to an electrical current source, one of said electrodes being active, the other of said electrodes being passive; at least one electromagnetic coil for generating non-contact electromagnetic stimulation, formed on an electrically insulating substrate, said substrate being associated with a heat sink; two separate compartments to house the electrical stimulation circuit connected to said electrodes on the one hand and the electromagnetic stimulation circuit powering said coil on the other hand; an electronic circuit for controlling the electrical and electromagnetic stimulation sequences.including a Bluetooth module to receive remote control signals for stimulation parameters.

[0021] Advantageously, the module according to the invention further comprises: a circuit for detecting the quality of contact between said electrodes and the user's skin, controlling the interruption of the electrical stimulation circuit in the event of non-compliant contact; and / or a temperature sensor to control the cessation of stimulation in the event of exceeding a threshold value; and / or a microcontroller controlling the resetting of the stimulation sequence based on the detection of operating errors; and / or an inertial circuit comprising an accelerometer and a three-axis gyroscope connected to said electronic circuit, controlled to adjust the electrical and electromagnetic stimulation sequences according to the movements of the user's head.

[0022] Preferably, the electronic circuit includes a microcontroller controlled by a real-time synchronization and modulation program for galvanic and electromagnetic stimulation, based on stimulation profiles predefined by the user via a mobile application.

[0023] Advantageously, the said case is covered by a silicone sleeve.

[0024] Detailed description of a non-limiting example of implementation

[0025] The present invention will be better understood upon reading the following description, concerning a non-limiting embodiment, illustrated by the accompanying drawings where: Figure 1 represents a schematic side view of a device support according to the invention; Figure 2 represents a schematic perspective view of a device support according to the invention; Figure 3 represents a schematic perspective view of a variant of the device support according to the invention; Figure 4 represents a schematic diagram of the electronic circuit of the device according to the invention. General principle of the invention

[0026] The invention relates to an electrical and electromagnetic stimulation module consisting of a substantially parallelepiped-shaped housing covered in silicone, and having two conductive electrical electrodes on its side that comes into contact with the user's skin. The user is equipped with two modules positioned on their skull by a support having two slots positioned to make contact with the user's mastoid muscles.

[0027] The invention differs from the prior art by: the use of two electrodes, and only two electrodes, positioned to make contact with the user's mastoid processes, connected to an electrical current source, one of said electrodes being active and the other passive. This configuration allows for targeted and effective galvanic vestibular stimulation (GVS) using the mastoid processes, areas anatomically close to the vestibular nerves. The active / passive asymmetry allows for precise current direction, improving the modulation of balance or posture perception. The use of at least one electromagnetic coil to generate non-contact stimulation, formed on an electrically insulating substrate, which is associated with a heat sink. Non-contact electromagnetic stimulation (GEMS) allows for non-invasive neuromodulation complementary to GVS. The insulating substrate ensures electrical safety and field stability.The heat sink manages the heat generated by the coil, preventing overheating and ensuring continuous, safe operation. The housing is divided into two separate compartments to accommodate the electrical stimulation circuit (connected to the electrodes) on one side and the electromagnetic stimulation circuit (powering the coil) on the other. This separation prevents electromagnetic interference between the two types of stimulation. It contributes to reliability, signal accuracy, and independent modulation of treatments. An electronic circuit controls the stimulation sequences and includes a Bluetooth module to receive remote control signals for stimulation parameters, allowing real-time adjustment of the parameters (intensity, duration, frequency) of each stimulation according to the patient's needs.This promotes user autonomy and therapeutic personalization, including through predefined profiles accessible from a mobile application.

[0028] The invention proposes a coherent and coordinated functional combination of technical means, the interaction of which produces an overall effect greater than the simple sum of their isolated effects. This synergy manifests itself along several interdependent axes, leading to real-time adaptation to physiological, behavioral, or contextual needs. This transforms the device into a customizable therapeutic platform, with an overall technical effect (coordinated, safe, effective, and adaptable neural stimulation) that cannot be achieved without this specific combination, thus demonstrating a true inventive synergy. Module support

[0029] Laet lare represent a side and perspective view of an example embodiment, consisting of a piece of elastically deformable flexible material, having a hook (1) in the general shape of a “C” to allow attachment around the ear, with an enlarged area (2) forming a flexible shell into which an electronic module described below can be inserted.

[0030] A cord (4) joins the right and left hooks and runs along the back of the head at the nape of the neck to ensure proper positioning on the user's head. This cord (4) forms a loop whose ends (5) meet and terminate in a knot (6) allowing the cord's length (4) to be adjusted and the device fitted to the user's head.

[0031] Laillustre illustrates a variant embodiment where the modules (3) are housed in two shells (10) connected by flexible hoops (11, 12). Description of a module (3)

[0032] The modules (3) are stimulation devices that combine both galvanic and electromagnetic stimulation for therapeutic or rehabilitation applications. Each module (3) has two electrodes placed, when the system is worn by the user, on the mastoid processes (behind the ears) to deliver a direct current to stimulate the vestibular nerves. This stimulation can be adjusted remotely via the onboard control system.

[0033] Miniaturized electromagnetic coils are integrated into the module (3). They are manufactured using microfabrication techniques in a cleanroom to guarantee contactless stimulation, which allows for a gentler and more targeted action on the areas to be treated.

[0034] Module (3) is equipped with a Bluetooth module, allowing the user or practitioner to control stimulation parameters remotely, which offers great flexibility in settings and personalization of treatments.

[0035] An induction-rechargeable battery eliminates the need for wired connectors, ensuring extended use and greater freedom of movement for the user.

[0036] The combination of galvanic and electromagnetic stimulation offers versatility in therapeutic applications, whether for vestibular disorders, neurological disorders or for virtual reality applications.

[0037] Bluetooth integration allows for real-time adjustment of parameters, improving the effectiveness and personalization of therapies. Galvanic Electrical Stimulation (GVS)

[0038] Two electrodes placed behind the ear serve as entry points for the galvanic current, one active and the other passive. The device allows for real-time control of the stimulation intensity via the multifunction button or mobile app, adapting to each user's needs. The intensity limit is programmed to prevent overstimulation, ensuring maximum safety. An integrated safety algorithm detects changes in electrode contact quality or sudden movements, and adjusts or temporarily interrupts the stimulation if a problem arises.

[0039] Using a mobile app, users can create and save multiple stimulation profiles tailored to different uses (e.g., low intensity for transportation, moderate intensity for virtual reality). These profiles can be easily activated, allowing for quick customization depending on the environment or therapeutic goal. Galvanic Electromagnetic Stimulation (GEMS)

[0040] The coil has a planar spiral or micro-winding solenoid shape to maximize magnetic field production in a confined space. A planar spiral allows for good focusing and a more uniform field. It is made of copper or aluminum, used in microfabrication for their high conductivity, on a thermally stable silicone or silicon oxide substrate suitable for cleanroom processing. Cooling systems

[0041] The coating will utilize a thermally conductive material, such as polymers or thermal ceramics, which dissipates heat to the skin without requiring additional components. A micro-fin-like structure, created through microfabrication, will increase the heat exchange surface area. These microstructures improve heat dissipation by maximizing contact with ambient air or skin. By incorporating materials with high thermal capacity, such as graphene or doped carbon, the coating could absorb heat fluctuations produced during stimulation, particularly during electromagnetic stimulation.

[0042] The electrical and electromagnetic stimulation circuits are housed in separate compartments of the device, each optimized to avoid electromagnetic interference. This physical isolation reduces the risk of electromagnetic "noise." Insulating materials (such as polymer coatings) are used to encapsulate each circuit, minimizing unwanted capacitive or inductive coupling between them.

[0043] Each circuit has its own regulated power supply, ensuring that the power delivered for electrical stimulation does not interfere with that of electromagnetic stimulation. This separation allows for specific power regulation for each type of stimulation.

[0044] A central microcontroller can synchronize the signals to ensure that the two types of stimulation operate without overlapping or interfering. For example, electrical stimulation could be pulsed at specific intervals to avoid conflicting with electromagnetic pulses.

[0045] The galvanic stimulation electrodes and electromagnetic coils are designed to operate independently. The coil is calibrated to generate an electromagnetic field without affecting the electrodes.

[0046] The operating frequencies of each circuit are defined to minimize interference. For example, electromagnetic circuits might operate at a different frequency than that used by galvanic stimulation circuits to reduce any interaction. Embedded computing

[0047] The electronic circuit includes an ESP32™ or STM32™ microcontroller with sufficient processing power and Bluetooth communication. It includes flash memory (minimum 512 KB) for storing the latest stimulation parameters, as well as a history of recent parameters for monitoring.

[0048] An integrated BLE module (like on the ESP32) minimizes power consumption. It will handle communication with PC software for configuration, recording, and retrieval of stimulation data.

[0049] A high-precision digital-to-analog converter (DAC) is used to generate the analog stimulation signals required for GVS and GEMVS. This component is essential for fine control of the intensity and frequency of the stimulation signals.

[0050] To retain a large volume of stimulation data (e.g., historical settings and user configurations), 4 GB of storage is integrated via an eMMC chip, providing fast and durable access to data.

[0051] Minimalist buttons on the device allow you to start, stop, and reset stimulation without using PC software. A multi-color LED indicates Bluetooth connection status, stimulation activity, and battery life.

[0052] A biocompatible silicone casing protects the electronics and minimizes the risk of skin reactions during prolonged use, with easy visual identification of the orientation.

[0053] Integrated system and interoperability with PC software

[0054] The device connects to the PC via Bluetooth, allowing dedicated software to send stimulation parameters or retrieve recorded data. The BLE connection ensures low latency for real-time synchronization during stimulation sessions.

[0055] The microcontroller stores the last stimulation parameters so the user can resume an identical session without reconfiguration. Configurations are also saved for recurring sessions, ensuring consistent results.

[0056] The PC software allows stimulation parameters (intensity, frequency, duration) to be sent to the device and session data to be retrieved for analysis. It displays current parameters and records history, offering complete control for the user or medical team. Security system and error management

[0057] To ensure user safety and device reliability, a safety and error management system is integrated. Its main features are: Automatic stimulation intensity limitation: The device has a maximum threshold for the current intensity sent to the electrodes. This limit is programmed into the microcontroller and prevents any stimulation beyond the user's tolerable level, thus reducing the risk of overstimulation or discomfort. Contact detection: The system can detect the quality of contact between the electrodes and the skin. If the contact is insufficient (for example, if movement displaces the electrode), the device temporarily interrupts stimulation and alerts the user via a light notification (LED) or the mobile app. Temperature monitoring: A temperature sensor integrated into the casing continuously monitors the device's temperature.If the temperature reaches a critical threshold, the system automatically stops stimulation to prevent overheating, thus ensuring user safety. Internal error detection and automatic reset: In case of malfunction (e.g., loss of Bluetooth connection, microcontroller error, or overvoltage), the device is programmed to detect the error and reset itself automatically. The device attempts to reconnect to the application and notifies the user if the problem persists. Error logging: The microcontroller records every incident or malfunction in an internal log. This log can be accessed via the mobile application or when connected to a PC, allowing engineers to diagnose problems and improve system performance.To keep the device up to date and respond to technological developments, an OTA (Over-The-Air) software update system is integrated.

[0058] Here are the main features of this system: Secure Update: Each OTA update is digitally signed to guarantee the authenticity and integrity of the update file. Before installation, the device verifies the signature to ensure it comes from an authorized source, preventing any attempt at hacking or installing unauthorized software. Secure Transfer Protocol: Updates are downloaded via Bluetooth using secure transfer protocols (e.g., AES 128 or 256 for data encryption), ensuring that the exchanged information cannot be intercepted or altered. Non-Blocking Update Process: The device is designed to perform updates in the background, allowing continued use without major interruptions. If a restart is necessary, a warning is sent to the user, who can then schedule the restart for a convenient time.Recovery mechanism in case of failure: If an update fails, the device automatically reverts to the previous software version, stored in a recovery partition. This rollback mechanism prevents software corruption and ensures the device's continued operation. Notifications and control via the mobile app: The user is notified of available updates via the mobile app. They can initiate and monitor the update process directly from the app, which provides information on the update status (e.g., download, installation, required restart). Integration of Motion and Orientation Sensors (IMU).

[0059] The device can be equipped with an IMU (Inertial Measurement Unit) module comprising an accelerometer and a three-axis gyroscope. This module allows for the detection and measurement of the user's body movements and orientation in space in real time.

[0060] The IMU sensor detects rotational, tilting, and acceleration changes in the user. This information is continuously processed by the device's microcontroller, which analyzes the user's dynamics (for example, if the user suddenly turns their head or leans forward).

[0061] Based on sensor data, the device adjusts stimulation parameters, including intensity, frequency, and timing, to synchronize artificial vestibular signals with the user's actual movements. For example: When head movement is detected, the device immediately adjusts the stimulation to compensate for the perceived movement, thus enhancing the immersive or stabilizing effect to prevent cybersickness. In the event of acceleration or braking (such as in a vehicle or simulator), the device adapts the stimulation intensity to mimic the perception of real acceleration and reduce disorientation. Optimizing desensitization therapy:

[0062] In the context of vestibular desensitization or rehabilitation, IMU allows for monitoring the user's progress by identifying the types and intensities of movement to which they are exposed. The device can then gradually increase stimulation to improve the user's tolerance to specific movements, enabling personalized and progressive therapy. Filtering of unwanted movements:

[0063] The IMU module uses a filtering algorithm to ignore extraneous movements (small involuntary movements) and focus on meaningful movements. This ensures that the device only reacts to changes in posture or accelerations that require stimulation adjustment. Biocompatible silicone casing

[0064] The silicone used is medical grade, meeting ISO standards for implantable devices, thus ensuring it is safe for prolonged skin contact without risk of irritation or allergic reaction. This material is perfectly suited for direct skin contact, even under conditions of prolonged wear.

[0065] The biocompatible silicone casing is molded to provide waterproof protection (IP67), preventing the ingress of dust and liquids. This waterproofing allows the device to be used in humid environments or in light rain, while also making it resistant to perspiration and splashes, which is essential for mobile or outdoor applications.

[0066] Silicone acts as a natural shock absorber, absorbing impacts and vibrations. Thanks to this protection, the device is less sensitive to physical impacts, thus ensuring greater durability, even in the event of a fall or during intense physical activity.

[0067] Silicone is a thermal insulator, protecting internal components from moderate temperature variations. This allows the device to operate reliably in hot or cold environments, with an estimated operating temperature tolerance between -10°C and 50°C.

[0068] Silicone is naturally resistant to many chemicals, including cosmetics, sweat, and other substances to which it might be exposed during use. This allows the device to maintain its performance and integrity even during daily use. Sealed case

[0069] The case is fully sealed using a screwless welding and assembly process. This seal protects the internal electronic components from moisture and dust, while also making the case more robust against repeated handling.

[0070] The device uses wireless technology (Bluetooth) for communication, and inductive charging could be considered, eliminating the need for exposed ports that could allow contaminants to enter. This enhances water resistance and improves durability. User interface

[0071] The device is equipped with minimal physical controls to facilitate quick interaction:

[0072] o On / Off Function: By pressing and holding the button (for example, 3 seconds), the user can turn the device on or off. A short vibration or beep confirms each action.

[0073] Intensity control: By briefly pressing the button, the user can increase the stimulation intensity in predefined increments (e.g., low, medium, high). A series of vibrations (1, 2, or 3) or multi-colored LEDs indicate the selected intensity level.

[0074] o Stimulation mode: A double press allows switching between different stimulation modes (continuous stimulation, intermittent stimulation, etc.), adapted to different uses (motion sickness, cybersickness, training).

[0075] The device includes LED indicators: Connection indicator: A flashing LED indicates the Bluetooth connection status (rapid flashing while searching for a connection, solid light when connected). Battery indicator: The LED changes color (e.g., green for full battery, yellow for 50%, red for low battery) or flashes red when the battery reaches a critical level. Active stimulation indicator: An LED light illuminates or flashes during stimulation, visually indicating that the device is in use. PC or Mobile interface via application

[0076] For more precise control and detailed monitoring, the device is paired with a PC or mobile application accessible via Bluetooth. This application offers advanced features: Dashboard: Real-time status: Displays battery status, stimulation intensity, selected mode, and Bluetooth connection status. Session history: Records each stimulation session with the parameters used (intensity, mode, duration). This history is accessible to allow users or healthcare professionals to track progress or make necessary adjustments.

[0077] Fine-tuning of stimulation: Intensity and frequency control: Allows for more precise manual adjustment of stimulation parameters (intensity and frequency) than the options on the device. Users can save specific stimulation profiles (e.g., for different types of use such as VR, transportation, training). Stimulation mode selection: The user can select from several predefined and customizable modes (e.g., continuous stimulation, intermittent stimulation, motion-synchronized stimulation, etc.).

[0078] The app sends notifications to alert the user when the battery is low, when a software update is available, or if an error is detected (such as poor electrode contact). This ensures the user is always informed about the device's status.

[0079] The application offers the option to launch OTA updates to ensure the device remains up-to-date with the latest security patches and functional improvements. Updates can be scheduled to install automatically or manually, with clear indicators of the update status.

[0080] The application may include an interactive user guide explaining the different stimulation options and modes of use, as well as tips for maximizing effects. Online support or a chatbot may also be integrated to answer frequently asked user questions. Schematic diagram of the electronic circuit

[0081] The figure represents an example of a schematic diagram of the electronic circuit of the stimulation device combining galvanic and electromagnetic stimulation according to the invention.

[0082] The device is powered by an inductively rechargeable battery (16), allowing for extended use without the need for wired connectors. This inductive charging system enables continuous operation while maintaining the device's water resistance and portability.

[0083] The device is equipped with a user interface (15), including controls and LED indicators to visualize the device's status (such as Bluetooth connection, battery level, and current stimulation status). This interface allows for quick and visual local control, in addition to the ability to control it remotely via the mobile app or PC software.

[0084] The stimulation module includes electrodes positioned on the mastoids to send direct current (DC) electrical currents. These electrodes are controlled in intensity and frequency by a circuit (11) to adjust the galvanic stimulation according to therapeutic needs, via a microcontroller (10).

[0085] Electromagnetic stimulation is provided by miniaturized electromagnetic coils, manufactured in a cleanroom, capable of generating contactless magnetic fields according to an excitation signal delivered by a circuit (12) controlled by the controller (10) to provide gentle electromagnetic stimulation, in addition to galvanic stimulation, thus offering a more complete therapeutic approach.

[0086] The core of the system is a microcontroller (10) that manages the interactions between galvanic and electromagnetic stimulation. This microcontroller (10) receives data from the IMU sensor (13) to adjust the stimulation parameters according to the user's movements, and uses information sent via the Bluetooth interface (14) to adjust the stimulation in real time.

[0087] The device incorporates an IMU (Inertial Measurement Unit) sensor (13), which detects the user's head movements and orientation. This sensor provides crucial information for adapting the stimulation to the environment or the patient's movements, thus improving therapeutic efficacy.

[0088] The device is equipped with a Bluetooth module (14) enabling wireless communication with PC software or a mobile application. This allows the user or therapist to customize and adjust stimulation parameters remotely, as well as monitor data in real time.

[0089] The device uses a combination of galvanic and electromagnetic stimulation to act on the vestibular nerves and other sensory systems, helping to treat balance disorders or neurological conditions. It is controlled via a simple user interface and Bluetooth communication for remote management. The IMU sensor adjusts settings based on detected movements, and the inductively rechargeable battery ensures extended, uninterrupted use.

[0090] This architecture makes the device versatile and portable, with the ability to adapt to the specific needs of the patient, while offering a user-friendly interface for local and remote control.

Claims

Stimulation module combining galvanic and electromagnetic stimulation, consisting of a housing having: two electrodes positioned to come into contact with the user's mastoids, connected to an electrical current source, at least one electromagnetic coil to generate non-contact electromagnetic stimulation, an electronic circuit for controlling the electrical and electromagnetic stimulation sequences. Characterized in that said housing has two separate compartments to house the electrical stimulation circuit (11) connected to said electrodes on the one hand and the electromagnetic stimulation circuit (12) supplying said coil on the other hand. In that one of said electrodes is active, the other of said electrodes being passive. In that said electronic control circuit includes a Bluetooth module (14) for receiving remote control signals of the stimulation parameters.And in that said electromagnetic coil for generating non-contact electromagnetic stimulation is formed on an electrically insulating substrate, said substrate being associated with a heat sink. Stimulation module according to claim 1, characterized in that it further comprises a circuit for detecting the quality of contact between said electrodes with the user's skin, controlling the interruption of the electrical stimulation circuit (11) in the event of non-compliant contact. Stimulation module according to claim 1, characterized in that it further comprises a temperature sensor to control the cessation of stimulation in the event of exceeding a threshold value. Stimulation module according to claim 1, characterized in that it further comprises a microcontroller (10) controlling the reset of the stimulation sequence according to the detection of operating errors. Stimulation module according to claim 1, characterized in that it further comprises an inertial circuit (14) including an accelerometer and a three-axis gyroscope connected to said microcontroller (10), controlled to adjust the electrical and electromagnetic stimulation sequences according to the movements of the user's head. Stimulation module according to claim 1, characterized in that said electronic circuit comprises a microcontroller (10) controlled by a real-time synchronization and modulation program for galvanic and electromagnetic stimulations, according to the stimulation profiles predefined by the user via a mobile application. Stimulation module according to claim 1, characterized in that said housing is covered by a silicone envelope.

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