EP2373369A1 - Dispositif mobile d autostimulation transcrânienne et procédé de commande et de régulation du dispositif - Google Patents

Dispositif mobile d autostimulation transcrânienne et procédé de commande et de régulation du dispositif

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Publication number
EP2373369A1
EP2373369A1 EP09763913A EP09763913A EP2373369A1 EP 2373369 A1 EP2373369 A1 EP 2373369A1 EP 09763913 A EP09763913 A EP 09763913A EP 09763913 A EP09763913 A EP 09763913A EP 2373369 A1 EP2373369 A1 EP 2373369A1
Authority
EP
European Patent Office
Prior art keywords
stimulation
electrodes
electrode
generator
current
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09763913A
Other languages
German (de)
English (en)
Inventor
Burkhard Brocke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ANT Applied Neuroscience Technologies GmbH
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2373369A1 publication Critical patent/EP2373369A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M21/02—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0072—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with application of electrical currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]

Definitions

  • the invention relates to a mobile device for on-demand transcranial auto-stimulation of circumscribed brain structures and brain systems and a method for controlling and regulating the device.
  • auto-stimulation is to be understood in the sense of self-stimulation of a user of the device, resulting in special
  • Brain structures are defined as brain structures that, as a whole, form a functional unit and control individual neurocognitive processes, such as processes of anxiety regulation.
  • the circumscribed brain structure does not necessarily have to be spatially circumscribed, but can extend network-wise over a larger area, with deep and shallow areas of the brain being parts of the network.
  • For stimulation especially flat areas of the network concerned come into consideration, which are located just below the skull and can be reached by the transcranial stimulation.
  • Brain structures and systems and the neuronal processes that take place in them are influenced, above all by the targeted alteration of neuronal membrane potentials and rates of fire.
  • the affected processes are primarily neurocognitive processes of behavioral regulation, such as neuroregulation of attention, processes of anxiety regulation, and neurocognitive processes of target tracking and shielding, shielding or amplifying intentions to act against competing intentions to act.
  • the neuro-cognitive processes of behavioral regulation generally play a crucial role in a variety of behaviors, such as the adaptation of attention to different needs, the efficient implementation of action intent, the efficient regulation of anxiety or the regulation of other emotional states or various mental disorders, such as for example, depressive disorders.
  • Effective behavioral control is also affected by substance use and dependence or substance withdrawal, for example in tobacco products, alcohol or drugs, in eating habits or in gambling addiction and risk behavior.
  • TMS transcranial magnetic stimulation
  • TES transcranial electrostimulation
  • DC stimulation tDCS
  • tRNA transcranial random noise stimulation
  • a stimulator for neurostimulation of the outer skin of the spinal cord in angina pectoris is known, with the stimulator being implemented surgically.
  • the prior art has a stimulator for one of the twelve cranial nerves, the vagus nerve, which is used in severe depression and is also being implemented surgically (Fiedler, U. & BajBouj, M., 2007, Neuromodulation by Vagus Nerve Stimulation in Depression, Journal of Neurology, Neurosurgery and Psychiatry, 8 (4), 22-28).
  • deep electrodes are known, which are introduced in severe, therapy-resistant depression surgically in deep brain areas.
  • TMS transcranial magnetic stimulation
  • ms millisecond
  • the intensity of the magnetic field is about one to two Tesla.
  • the magnetic field penetrates through the skull bone and induces a very short current flow. This in turn generates neural discharges in a narrowly defined area of a few cubic centimeters.
  • the coil current is thus first converted into magnetic energy and then converted into electricity in the neurons.
  • rTMS repetitive TMS
  • anodal stimulation positive pole is near the cell body or the dentrides
  • depolarization is effected by increased membrane potentials and firing rates and thus increases the excitability.
  • cathodal stimulation neurons are hyperpolarized by decreased membrane potentials and rates of fire and the excitability is reduced.
  • tRNA transcranial random noise stimulation
  • an oscillation spectrum is applied for a signal with, for example, 1 mA current and random frequencies of-depending on the sampling rate-for example 0.1 to 640 Hz. All the coefficients of the frequency spectrum are of the same size ("white noise"), thus achieving similar effects as in the anodal tDCS: an increase in the excitability of circumscribed brain areas, which offers greater independence of the direction of current flow from the cortex turns Moreover, because of the oscillation, no polarization is produced, the likelihood of the user occasionally being slightly aware of the flow of current is virtually eliminated.
  • excitability changes are proportional to the number of repetitive TMS stimuli or duration of electrical stimulation. However, they persist beyond the duration of stimulation for a limited time due to an after-effect or long-term effect. As a result, for applications such as neurological dysfunctions associated with changes in neuronal excitability, suggestibility over somewhat longer periods of time results. In an anodal DC stimulation of about 15 minutes excitability increases of up to two hours are possible, with 10-minute cathodal DC stimulation long-term effects of up to one hour can be induced.
  • the length of these after-effects depends on the total induced charge in tDCS and on the number of repetitive pulses in rTMS.
  • the total induced charge in the tDCS results from the current, the electrode area and the stimulation time when linked according to the formula:
  • a device for transcranial influencing of the central nervous system in case of malfunctions is described in EP 0497933 B1.
  • a magnetic field is used to compensate epileptic foci. It low-frequency magnetic fields of low strength, 2 to 7 Hertz and 0.5 to 7.5 Picotesla, are used.
  • An arrangement of a plurality of electromagnets in a special headgear allows the local application according to the application of the magnetic fields. From a generator, the energy required to operate the electromagnets is controlled and delivered.
  • a device for transcranial neurostimulation is disclosed in US 2006/0173510 A1 with a special electrode arrangement.
  • a major disadvantage of non-invasive devices and methods is the need for a stationary device as part of the device, so that the application is localized. If there is an acute need for stimulation, it can only be fulfilled if the person to be stimulated is located directly on the stimulator. Leaving the site will only allow for an aftereffect that lasts for more than two hours, depending on the type of stimulation. When removed from the stimulator so limit the location of the device and the maximum achievable duration of action (maximum after-effect) and the operating time and the range of motion of the user. Repeated stimulation (with safety interruption after 15 minutes) is not possible because of the distance from the device. The currently achievable maximum duration of action is therefore unsuitable for the intended purposes, because the entire awake time of day has to be covered.
  • Object of the present invention is to provide a device for transcranial auto-stimulation and a method for controlling the device, which are technically designed so that in contrast to transcutaneous electrostimulation neuronal membrane potentials are effectively influenced in predetermined target areas and that in addition to highest reliability the device is also given the mobility for the user of the device.
  • a mobile device for transcranial auto-stimulation which comprises the following components:
  • Electric energy storage and a monitoring and security module with separate electric energy storage are separately electric energy storage.
  • control unit of the stimulation generator contains at least one program for determining the pulses to be emitted by the current generator with regard to the permissible value range of the electrical, topographical and temporal parameters required for the target area and purpose for the intended change of the neural
  • a user interface of the stimulation generator has program selection buttons, via which the program is selected for the relevant clinical picture.
  • function call buttons are provided in the user interface.
  • An ad completes the user interface.
  • the monitoring and security module which monitors, controls and regulates the correct operation of the device.
  • the monitoring and safety module is equipped with a separate electric energy storage.
  • a particular advantage of the device according to the invention is that it is independent of location and mobile in a variety of application situations and in the.
  • Stimulation can be applied.
  • the device is designed and secured in such a way that no medically trained personnel is required for routine use.
  • the microcontroller of the monitoring and safety module is equipped with a simple but efficient, extremely energy-saving and fail-safe buffered power supply.
  • the Monitoring device protects against errors in the program sequence or deviation of the stimulation process from the control algorithm and crash of the control software.
  • the monitoring and security module is equipped with a watch-dog system, which requires the program after each unit of time, for example every 10 ms, a precisely defined signal sequence. Should the signal sequence fail, the monitoring device will reset the control and, if necessary, force the software to restart.
  • a preferred embodiment of the invention is the application for transcranial direct current stimulation.
  • the power generator is designed as a DC generator and there are two electrodes provided on the scalp.
  • the neuronal discharge rates and thus the activity and excitability in the target area is increased with anodal alignment of the current flow direction and inhibited by cathodal alignment of the current flow direction.
  • an advantageous embodiment of the invention is that the function call buttons for retrieving a stimulation protocol from a program by the user or the entire user interface are designed as a remote control for the stimulation generator.
  • the remote control is designed wireless or wired, the wireless configuration allows a particularly inconspicuous application of the device in everyday situations.
  • Smartphones, mobile phones or PDAs on which keys are assigned as function call buttons can also be advantageously used as remote controls, the devices having corresponding interfaces on which tailored programs can run.
  • the monitoring and security module preferably has a separate microcontroller and uses as a separate energy storage to the buffered power supply in case of failure, a capacitor.
  • the electrodes each have an area of 25 to 35 cm 2 .
  • the electrodes are formed of electrode sub-areas with an area of less than 25 cm 2 .
  • a plurality of electrode sub-areas are arranged like a grid, wherein the areas acting as electrodes are formed by driving one or more electrode sub-areas.
  • This embodiment is developed particularly advantageous in that the electrode sub-areas are integrated into a headgear, as with a universal, a plurality of electrode portions containing headgear diverse applications are connected without the device and the associated medical application is visible to outsiders.
  • the stimulation generator is connected via connecting lines with the grid-like positioned plurality of electrode sub-surfaces in the headgear.
  • the control unit is designed such that, according to the program to be executed, it only controls the electrode sub-areas for the region to be stimulated.
  • Electrode surfaces is integrated into the headgear.
  • the headgear is expedient helmet designed to ensure sufficient stability.
  • the user interface is advantageously arranged in a separate wirelessly connected remote control to make the operation of the stimulation generator without having to remove the headgear.
  • the device for transcranial electrostimulation contains a speech module with headphones or speakers, which is preferably integrated into the stimulation generator or also formed separately from the stimulation generator, but coupled with the stimulation protocol.
  • the stimulation protocol based on the current electrical stimulation parameters, stores audio sequences that support the application and effect of the stimulation. This allows a combination of spoken instructions from therapy and behavioral programs and transcranial stimulation, which allows a particularly effective use of the device.
  • the user interface is executed together with the wireless remote control with the function call buttons acting on the control unit and connected to the stimulation generator together via the connecting lines with the electrodes.
  • the stimulation generator is designed with a designed as a bracelet attachment strap for attachment to the user's wrist, wherein the user interface integrated in the stimulation generator and this is connected via the connecting lines with the electrodes.
  • a wireless remote control for the control unit of the stimulation generator which has at least function call buttons.
  • electrodes or electrode subareas are advantageously designed as sensors for determining the contact resistances, the signals of which are processed by the monitoring and security module.
  • the optimum electrode area required for a treatment can be calculated and switched by the control unit as a function of the selected program. Operating errors are thus excluded in relation to the electrode size depending on the type of treatment.
  • the required intensity of the stimulation current is achieved over the permissible minimum total electrode area.
  • the device was designed such that 1. the required influencing of the membrane potentials is achieved, 2. that the user himself can safely apply the device, and 3. that the device has a high degree of safety in its functionality.
  • the first and second aspects are mainly taken into account by the technical design of the device with the control module and the program selection and function call buttons.
  • the third aspect is realized by a method of controlling and regulating the device, which controls the duration and intensity of the stimulation with respect to the respective permissible size.
  • the stimulation process and all involved components, for example the electrode resistances, are monitored and the system is reset if necessary.
  • the procedure involves the following steps: a) selecting a program by means of the program selection button on the user interface, b) selecting and recalling a stimulation unit stimulation protocol that changes the neural membrane potential and rate of fire in the target area of the cortex in the desired and desired range possible strength for the desired and permissible duration, by means of the function call buttons, c) monitoring and limiting the stimulation by means of the monitoring and safety module of the stimulation generator.
  • the parameters current, voltage, stimulation duration, electrode position and electrode surface are the directly measurable and controllable parameters, which are coordinated so that the total charge amount and the maximum current density is not exceeded.
  • the stimulation current In monitoring, for example, a gradual increase in the electrode resistance in the range of minutes or seconds, a detachment of the electrode can be detected. In this case, the stimulation current must be proportionally reduced in order to keep the current density constant and tissue damage due to excessive current density excluded. If preset limits are exceeded, the system is shut down.
  • the grid-like positioned electrodes in the helmet as sensors measure the contact resistance
  • the measured value is reported to the control unit and processed.
  • a corresponding number of the grid-like positioned plurality of electrodes is driven in order to achieve the required intensity of the stimulation current.
  • stimulation protocols can be generated, which are characterized primarily by the parameters pulse duration, pulse strength, electrode area and charge quantity as well as the electrode positions and electrode polarities for aligning the electric field.
  • pulse duration characterized primarily by the parameters pulse duration, pulse strength, electrode area and charge quantity as well as the electrode positions and electrode polarities for aligning the electric field.
  • DLPC dilateral prefrontal cortex
  • vmPC ventromedial prefrontal cortex
  • TK temporary cortex
  • insula the insula
  • buttons for easy and safe retrieval of electrical impulses of different characteristics while the program is running easy operation through multiple buttons that are systematically coordinated with each other, application advantage through possibility of auto-stimulation through simple and safe application by the user,
  • Stimulation protocols which are individual and need-based and in which the parameters of the respectively suitable stimulation are precisely defined, application advantage through the possibility of safe, individual and demand-dependent self-stimulation by the user,
  • buttons as central functional units of the utility nterfaces or a remote control
  • Electrode electrodes or electrode array can be variably controlled and there is an automatic impedance control, application advantage by individually adapted choice of the electrode position, increased efficiency and flexible control depending on the selected program,
  • Miniature stimulation generator and electrode array integrated as a functional unit in headgear integrated as a functional unit in headgear.
  • transcranial DC stimulation in the following manner:
  • the large electrodes which must be precisely positioned to reach the target area, make contact with the scalp.
  • a weak, continuous current flow a DC pulse, generates a static electric field that modulates the activity of the neurons in the brain or target area.
  • the neurons respond to the electric field with a low membrane potential shift and altered rate of fire, which changes their excitability. With anodal stimulation there is an increase in the resting potential, the rate of fire and the excitability, with cathodal stimulation a reduction.
  • inhibitory or excitatory membrane potential shifts or excitability changes are used to specifically influence circumscribed, ie spatially or functionally limited, neuronal circuits and areas that are relevant to the behaviors that are relevant here, for example attention regulation, target tracking and shielding, anxiety regulation, substance use and substance withdrawal, eating behavior, underlying.
  • Functional activation or inhibition processes of these circuits are induced or enhanced, dysfunctional activation or inhibition processes are inhibited or blocked.
  • the neural circuits underlying the behavioral regulation processes can be effectively manipulated in the areas close to the cortex surface.
  • Control of alcohol consumption anodal stimulation of the DLPC
  • Nicotine Anodal stimulation of the DLPC, cathodal stimulation of the insula
  • Neuroregulation of attention anodal stimulation of the DLPC
  • IGF inferior frontal gyrus
  • neural processes can be selectively activated or inhibited
  • FIG. 1 electrode arrangement in transcranial DC stimulation
  • FIG. 2 back of the head with positions of the electrodes
  • FIG. 3 view of the electrostimulation device with user interface, control unit and DC generator
  • Fig. 4 Arrangement of the electrostimulation device on the user's upper arm
  • Fig. 5 Arrangement of the electrostimulation device together with the
  • Electrodes in a hood in the helmet Fig. 6: Control unit as remote control, Fig. 7: Functional diagram of the electrostimulation device.
  • Figure 1 shows the head of a user of a device for DC stimulation with applied electrodes 3, which are connected as the cathode and anode, as well as for the directing of the DC pulses from the DC generator, not shown to the electrodes 3 required connection lines 4.
  • the exact location of the electrodes 3 is respectively determined so that the electric field reaches the appropriate brain area for the particular application as accurately as possible.
  • the exact positioning required for each application can be accomplished by known techniques with a neuron navigator or landmarks.
  • the definition of the target area can be found in the operating instructions of the electrostimulation device and is carried out by the user. Coordinated with these are the stimulation protocols provided for the respective application situation, which represent the pulse characteristic, the current intensity and the stimulation duration, defined in the control program, which is stored in the control unit (not shown).
  • a helmet is provided as a headgear with built-in electrodes 3 for safe operation, which is placed on the head of the user.
  • the helmet has an internal hood, which conforms to the user's head and with which the electrodes 3 are accurately positioned.
  • the helmet has numerous, arranged in a grid electrode partial surfaces.
  • the electrodes 3 are installed fixed in position in the helmet and connected to the DC generator in such a way that the electrode sub-areas are driven individually or in groups with pulses. Like the interconnection is determined by the controller and the program stored therein to stimulate the target area in the brain.
  • An advantageous embodiment further consists in that the electrodes or the electrode sub-areas are designed as sensors for determining the contact resistance, with the parameters of which the optimization of the control of the electrode sub-areas is calculated with varying contact resistances from the control unit.
  • the actively driven electrodes will then be in accordance with the selected program and retrieved stimulation protocol
  • Electric energy supplies and transmits the impulses by an electric
  • Amperage can be formed in a certain amount and with a fixed duration, via the scalp to the circumscribed brain areas.
  • the other, non-active electrodes of the electrode cap are in this phase without function and may be in the execution of another
  • Electrode cap so short ways for the electric
  • the stimulation generator is operated by means of a remote control on which the user interface with the
  • Figure 2 shows the back of the head of a user of the device with the arrangement of the electrodes 3 and demonstrates the use of so-called landmarks.
  • the line between Inion 7, the tactile soft point between the lower end of the skull and the upper end of the cervical spine, and the Nasion the Transition from the bridge of the nose to the forehead.
  • the cathode is arranged 3.5 cm above the Inion 7, the anode 6 is located 4.5 cm to the right of the cathode 5.
  • a stimulation of the visual system is possible.
  • the stimulation current is about 0.001 to 0.002 amperes, anodal or cathodal polarizable. However, it can be increased to 0.005 amperes depending on the other parameters.
  • FIG. 3 shows an embodiment of the stimulation generator 16 which comprises the DC generator, the control unit and the user interface and to which a fastening band 8 is provided.
  • the fastening strap 8 is designed as a bracelet for fastening the stimulation generator 16 on the forearm of the user or as a strap for fixing on the body of the user.
  • the stimulation generator 16 also has in the illustrated embodiment, two terminals 11. At these, the connecting lines 4, not shown here are attached to the electrodes 3 via suitable connector and the electrodes 3 connected to the DC generator of the stimulation generator 16. Since the user interface includes the function call buttons 15, no remote control for external operation of the stimulation generator 16 is required. The function call buttons 15 are then as well as the program selection buttons 9 of the user interface to operate on the same surface. In this embodiment, the retrieval of the stimulation protocols via the function call buttons 15 takes place directly on the stimulation generator 16. In order to avoid incorrect operation by the user, for example in stressful situations, the program selection buttons are additionally executed code-secured.
  • the stimulation program is activated or, with several available programs, the desired program is selected.
  • the number of programs themselves and the relevant specific parameters of the programs are specified by the manufacturer of the device and preset and protected to ensure the intended use of the device against improper modification by a common coding method.
  • an alternative, not shown embodiment with high ease of use, which is particularly suitable for covert use in various everyday situations, is that for retrieving the stimulation protocols, an external remote control with function call buttons is used with which suitable for the particular application situation and in the Program specified pulse characteristics are retrieved after the stimulation protocol.
  • the signal is the
  • the controller of the device is integrated with the stimulation generator 16 and performs the control of the stimulation, the current regulator and the management of the deployment protocol.
  • the operation of the monitoring and safety module is particularly energy-saving, independent and executed in the event of a fault without resorting to the energy resources of the stimulation generator.
  • the user When operating the device via the external remote control or integrated in the stimulation generator user interface, the user triggers a stimulation by pressing a button on one of the function call buttons 15, each of the function call buttons 15 a different high, discrete induced total charge within the range specified by the set program range makes it possible and retrievable.
  • the display 10 displays information for visually checking the current operation of the active stimulation program, and optionally other parameters such as percent of maximum charge amount, duration of treatment, duration of the pulses, type of pulses, charge status indicator of the battery, and the like.
  • FIG. 4 schematically shows a user with a neurostimulation device 1 for transcranial random noise stimulation (tRNS) with the attachment of the stimulation generator 16 to the upper arm.
  • tRNS transcranial random noise stimulation
  • a remote control is used, with which the start of the program and the choice of pulse duration and pulse strength can be done via the function call buttons.
  • the signal from the remote control is known to a person skilled in the art
  • Encryption method is encrypted in such a way that an influence by another remote control or a similar received signal is excluded.
  • the stimulation generator 16 is attached to the attachment strap 8, designed as a bracelet, on the user's upper arm.
  • the electrodes 3 are located on the user's head in the position specified for the purpose.
  • the power generator integrated in the stimulation generator 16 and the electrodes 3 are connected by means of the electrical connection lines 4, whereby the stimulation current is conducted from the current generator to the electrodes 3.
  • the cortical excitability in the target area With the help of the described tRNA, it is possible to increase the cortical excitability in the target area. With higher frequencies between, for example, 100 and 640 Hz, this effect can be achieved particularly well by the repeated and rapid opening of the cellular sodium channels (Na +).
  • the smaller stimulation electrode of, for example, 20 cm 2 above the target area and the larger reference electrode of, for example, 80 cm 2 are placed contralaterally.
  • Current parameters of 1 mA and 10-minute pacing duration for given current density limits are generated and limited by the control module and backed up by the monitoring and protection module.
  • tRNAs have greater independence from the specific structure of the target area (convolution) compared to cathodal / anodal stimulation and the greater efficiency in the excitatory effects in the target areas (multiple opening of the Na + channels). Finally, the safety aspects to be controlled are less dangerous because non-polarizing electrical currents appear to be fundamentally safer.
  • FIG. 5 shows a particularly advantageous embodiment of the invention, in which the stimulation generator 16 is integrated together with the electrodes 3 in a headgear designed as a helmet 14, the electrodes 3 being fastened to a hood belonging to the helmet 14, which is pulled over the head are.
  • the electrodes 3 are already positioned by their attachment to the hood of the helmet 14, whereby the neurostimulation device 1 is easier to handle by the user.
  • the operation of the stimulation generator 16 is performed by a remote control. This is for example attached to the wrist of the user and connected via a connecting line 4 or wirelessly connected to the control unit of the stimulation generator 16 in the helmet 14.
  • a remote control a programmable mobile phone, a PDA or a smartphone can be used.
  • the helmet 14 has a plurality of electrode sub-areas 2, which are all connected to the stimulation generator 16 and individually controllable.
  • the helmet 14, which is pulled with the electrode part surfaces 2 built into it on the head of the user, is particularly suitable for the safe operation of the stimulation device 1, since a positioning of the electrodes 3 on the scalp is eliminated.
  • 500 electrode sub-areas 2 are housed in a grid of 25 electrode sub-areas 2 in longitudinal and 20 electrode sub-areas 2 in the transverse direction, each square with appropriate size between 8 and 18 millimeters side in the helmet 14.
  • the positioning of the electrodes 3 is completely user-independent possible by several electrode sub-areas 2 depending on the selected program in the area to be stimulated by the stimulation generator 16 are automatically controlled.
  • boundary conditions such as the electrode resistance (impedance) of the user, are reacted. If the electrode resistance is high, more electrode partial areas 2 are generated by the stimulation generator 16 in order to apply the required pulse strength controlled as with low electrode resistance.
  • at least individual electrode sub-areas 2 are designed and connected as sensors and the determined measured value is processed in the control unit.
  • the control algorithm for taking account of the electrode resistance cooperates with the security system described in more detail.
  • the prefrontal cortex may be stimulated for smoking therapy, but possibly also the insula.
  • Another example illustrates the merits of this embodiment. For example, if a more focal stimulation of the target area is to be achieved, a higher current density can be achieved over a smaller switched electrode area, but this must be compensated by the remaining parameters of the induced total charge amount.
  • FIG. 6 shows the remote control 12 with the function call buttons 15 and a display 10.
  • the remote control 12 is connected to the stimulation generator 16 by means of connection lines, not shown, at the connections 11.
  • the remote control 12 is designed for wireless operation of the stimulation generator 16 and then has a transmitter and a receiver unit with antenna 13 and a power source.
  • FIG. 7 shows an overview of the control and regulation algorithm of the stimulation generator.
  • the program and the stimulation protocol are selected via the user interface and converted into signals for the stimulation output via the control unit and the current generator and, if appropriate, the speech module.
  • the parameters are recorded and processed for processing with the signals from the sensors to the supervisory and control panel Pass safety module. After evaluating and checking the data, these are output via a display in the user interface and feedback is performed on the control unit of the stimulation generator.
  • the operating concept for the device is that one or more stimulation programs with the corresponding electrical, topografi see and timed parameters are retrievable stored in the control unit.
  • the standard pulse types used are defined via the parameters Current and Voltage. Further parameters are the stimulation time, the electrode area, the electrode position for the desired influence on the activity of the target area, the charge quantity and the current density.
  • Suitable pulses with the characteristic provided for each purpose in the stimulation protocol are currents between 0.001 ampere and 0.002 ampere, in some cases up to 0.005 ampere, and a stimulation time of up to 900 seconds.
  • the control of the stimulation and the monitoring and security module are functionally separated from the user interface and the remote control.
  • the control unit in turn interacts directly with the monitoring and security module.
  • the pace of the pacing algorithm is constantly monitored for security risks. These consist of an overdose of stimulation in strength or duration caused by program or hardware failure. Furthermore, there is a risk due to the occurrence of harmful overvoltage.
  • the correct seating of the electrodes is checked by monitoring the contact resistance.
  • the effect of the safety system may stop the stimulation from exceeding one or more limits, such as maximum current, maximum stimulation time, total charge amount, and maximum current density.
  • the functions of the battery charge are checked and this secured against destruction by overcharging.
  • the mission protocol stores the course of the stimulation. This information about the last stimulation can be retrieved. But it is also necessary to monitor time integral quantities. This is especially true for limiting the amount of charge used for stimulation.
  • the messages of the mission protocol are forwarded to the user interface and can be read on the display.
  • a current regulator is connected before the stimulation output and also connected to the usage protocol.
  • the stimulation is controlled according to the program selected by the user.
  • the controller is monitored by a monitoring and security module that performs the following functions:
  • the unit monitors and limits the amperage and applied power. This eliminates injuries and ensures that the current is below the threshold.
  • the contact resistance of the electrodes is monitored to prevent injuries as the contact resistance increases. Increasing contact resistance can also be partially or completely dissolved
  • the current density during stimulation must be limited by connecting further suitable electrode surfaces or the stimulation stops.
  • Pulsed stimulation may occur in the event of a cable break or detachment of an electrode. Pulsed electricity has a much lower stimulation threshold and can be painful even at low currents. The device therefore recognizes a loose contact via the control unit and, in this case, stops the stimulation.
  • the microcontroller is equipped with a simple but efficient, extremely energy-saving and in the event of a failure independent operating current buffered monitoring device against errors in the program sequence or deviation of the stimulation process from the control algorithm and crash of the control software.
  • the microcontroller of the monitoring and safety module is equipped with a watch-dog system, which requires the program after every one unit of time, for example every 10 ms, a precisely defined signal sequence. Should the signal sequence fail, the monitoring device will reset the control and, if necessary, force the software to restart.
  • control program comes into an undefined state as a result of a defect, a program error or high-energy radiation, it is aborted after 10 ms in the worst case and restarted if necessary. A risk is therefore excluded even with complex control software and harsh operating conditions.
  • the safety-relevant control functions work according to the journaling principle, an automatic application protocol is kept, so that all stimulation processes are traceable. For example, if the stimulation program provides an increase in stimulus current, the program generates an entry in the journal that includes the current algorithm step and the current increase. Finally, it adds the change made to the journal. A restart of the control software thus leads to all safety-relevant Functions without loss of information continue seamlessly.
  • the current regulator is switched in front of the stimulation output.
  • the remote control is cryptographically secured and the transmitter unit is physically separate from the other control units. This ensures that no other remote control can trigger a stimulation.

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Abstract

L'invention concerne un dispositif mobile d'autostimulation transcrânienne en fonction du besoin de structures cérébrales et de systèmes cérébraux décrits et un procédé de commande et de régulation du dispositif. L'invention concerne notamment un dispositif d'électrostimulation transcrânienne qui comprend les composants suivants : - des électrodes avec des moyens de fixation pour le positionnement précis sur le cuir chevelu et des lignes de connexion électrique et - un générateur de stimulation transportable miniaturisé comprenant un générateur de courant, un module de commande, une interface d'utilisateur, un accumulateur d'énergie électrique et un module de surveillance et de sécurité doté d'un accumulateur d'énergie électrique séparé.
EP09763913A 2008-11-21 2009-11-20 Dispositif mobile d autostimulation transcrânienne et procédé de commande et de régulation du dispositif Withdrawn EP2373369A1 (fr)

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DE102008043973A DE102008043973B4 (de) 2008-11-21 2008-11-21 Vorrichtung zur transkraniellen Neurostimulation
PCT/EP2009/065588 WO2010057998A1 (fr) 2008-11-21 2009-11-20 Dispositif mobile d’autostimulation transcrânienne et procédé de commande et de régulation du dispositif

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CN102245253A (zh) 2011-11-16
WO2010057998A1 (fr) 2010-05-27
DE102008043973A1 (de) 2010-06-10
US20110288610A1 (en) 2011-11-24
DE102008043973B4 (de) 2011-12-01
KR20110086611A (ko) 2011-07-28
JP2012509121A (ja) 2012-04-19
US8554324B2 (en) 2013-10-08

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