Granted Patent B2

US 12,444,489 · App. 17/866,423 · Granted Oct 14, 2025

Inventors: Krzysztof Mateusz Malej (Warsaw, PL); Pawel Sebastian Soluch (Warsaw, PL); Mateusz Marek Orzechowski (Warsaw, PL); Justyna Julia Garnier (Warsaw, PL)

Assignee: Neuro Device Group S.A.

G16H20/30A61N1/36025A61N1/36034G09B19/04G16H40/63G09B7/00

Abstract

Claims (56)

1. A brain stimulation system for performing a method for treating aphasia, comprising:

a) a computer program product comprising program code which, when loaded and executed on an electronic control unit, provides an operation control system, or

b) an electronic control unit with a program code loaded on the electronic control unit, wherein the program code, when executed on the electronic control unit, provides an operation control system,

wherein the operation control system is configured to control a brain training and/or stimulation session for a brain, and

wherein the operation control system comprises a plurality of control system functionalities, the control system functionalities comprising:

a stimulation functionality which is configured to cause the electronic control unit to issue a stimulation command to an electrical brain stimulation device to cause the electrical brain stimulation device to perform an electrical brain stimulation procedure; and

a presentation functionality which is configured to cause the electronic control unit to issue a presentation command in order to present a task to be performed by a user on a user interface,

wherein the brain stimulation system is configured to:

a) provide external transcranial alternating current stimulation (tACS) to at least one language-related area of a brain of a user, wherein the frequency of a current of the tACS is within the high gamma frequency range of 70 Hz to 80 Hz;

b) present a set of tasks to the user to prompt a response;

c) synchronizing the tACS with the set of tasks presentation; and

d) provide a pause to the tACS and the presentation of the set of tasks to allow recovery by the user,

wherein the brain stimulation system is configured to be used for treating aphasia of the user, and

wherein the operation control system comprises a session operation protocol interface functionality which is configured to receive session operation data for the brain training and/or stimulation session, wherein the session operation data comprises one, an arbitrarily selected plurality of, or all of the following data:

data on whether a preparation stimulation is to be performed during the brain training and/or stimulation session,

data on whether a task stimulation is to be performed during the brain training and/or stimulation session,

one or more stimulation parameters for the electrical brain stimulation procedure which is (are) to be performed,

data on the difficulty of the tasks to be presented,

wherein, in order to get access to the session operation protocol interface functionality an authentication procedure has to be successfully completed by a practitioner different from the user.

2. The brain stimulation system of claim 1 , wherein the operation control system is configured such that, during the brain training and/or stimulation session, at least one stimulation command for alternating current mode, is issued in synchronization with the presentation of a task on the user interface.

3. The brain stimulation system of claim 1 , wherein the presentation functionality is configured to select the task to be presented on the user interface from a plurality of tasks of different levels of difficulty, wherein the level of difficulty of the task to be presented is selected by the presentation functionality based on presentation data provided to or calculated by the operation control system.

4. The brain stimulation system of claim 1 , wherein the operation control system comprises a performance assessment functionality, wherein the performance assessment functionality is configured to calculate or to provide task performance data which is indicative for the performance of a task by the user.

5. The brain stimulation system of claim 1 , wherein the operation control system further comprises a stimulation adjustment functionality which is configured to adjust stimulation data for one or more subsequent stimulation procedures during the same brain training and/or stimulation session or a subsequent brain training and/or stimulation session for the same user.

6. The brain stimulation system of claim 1 , wherein the operation control system comprises a user feedback functionality, which is configured to cause the electronic control unit to issue a feedback command in order to present a feedback to the user, wherein the feedback or the feedback command is based on user-specific performance data related to the user, wherein the feedback optionally is one of, any arbitrarily selected plurality of, or all of:

a feedback to the user during the brain training and/or stimulation session,

a feedback at the end of the brain training and/or stimulation session after the last task has been presented, and/or

a feedback at the beginning of a subsequent brain training and/or stimulation session, wherein the respective feedback is performance-indicative and/or performance-dependent feedback.

7. The brain stimulation system of claim 1 , wherein the operation control system comprises a user condition monitoring functionality which is configured to determine based on user condition data indicative for the current condition of the user, and/or based on one or more physiological parameters of the user, which may be monitored by the brain stimulation system, during the brain training and/or stimulation session whether the brain training and/or stimulation session is continued or whether the brain training and/or stimulation session is stopped or interrupted, in order to avoid excessive cognitive load for the user, wherein, if the brain training and/or stimulation session should be stopped or interrupted, the operation control system is configured to cause the electronic control unit to issue a stop session command or an interrupt session command to stop or to interrupt the brain training and/or stimulation session.

8. The brain stimulation system of claim 1 , wherein the operation control system comprises a session number tracking functionality which is configured to track or count the number of brain training and/or stimulation sessions which have been initiated, completed and/or stopped, wherein, when the number has reached a predetermined maximum, the operation control system is configured to prevent initiation of a subsequent brain training and/or stimulation session.

9. The brain stimulation system of claim 1 , wherein the operation control system comprises a telemetry or transmission functionality which is configured to transmit session data acquired or generated during the brain training and/or stimulation session to a remote location device, such as to a remote computer or a data storage, wherein the session data optionally comprises one of, any arbitrarily selected plurality of, or all of:

user-specific performance data,

stimulation-specific data comprising data on whether a stimulation procedure such as a preparation stimulation and/or a task stimulation has been performed during the brain training and/or stimulation session and/or data on the stimulation parameters used for the stimulation procedure or stimulation procedures,

user condition-specific data comprising a user condition data log over the entire brain training and/or stimulation session,

user-specific data comprising information on the user which is or was subject to the brain training and/or stimulation session,

task-specific data comprising information on what tasks were presented, on the difficulty of the task, and/or on the time it took the user to complete the task, and/or on the quality of the performance of the specific task by user,

session-specific data comprising session duration, number of tasks presented during the brain training and/or stimulation session, and/or whether the brain training and/or stimulation session has been completed as planned or has been interrupted before its completion, wherein the telemetry or transmission functionality, optionally, is configured to transmit the session data during the brain training and/or stimulation session or only thereafter.

10. The brain stimulation system of claim 1 , wherein the brain stimulation procedure is performed using stimulation data which comprises one, an arbitrarily selected plurality of, or all of the following stimulation parameters:

amplitude and offset of a current signal for a varying current stimulation procedure;

frequency, range of frequencies and/or phase and/or range of phases and/or offset of the current signal for the alternating current stimulation procedure;

presence or absence of an electrical brain preparation stimulation procedure performed in the same brain training and/or stimulation session but before presentation of the task;

magnitude of the current applied in a constant current stimulation procedure;

duration of an electrical brain stimulation procedure;

start of an electrical brain stimulation procedure; and/or

duration of an electrical brain stimulation procedure relative to a typical duration required for performing the task or by using an absolute value.

11. A brain stimulation arrangement comprising the brain stimulation system of claim 1 , and a user condition monitor device which is configured to monitor one or more physiological parameters of the user indicative for the cognitive workload of user.

12. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured to treat a user who is a patient.

13. The brain stimulation system according to claim 1 , wherein the brain stimulation system is used to treat aphasia after the user having suffered a stroke.

14. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that no tasks are presented to the user or solved by the user during the pause.

15. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that the frequency of the current of the tACS is at approximately 75 Hz.

16. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that the pause is provided after ten minutes of the tACS.

17. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that the pause is provided after a period of time longer than 5 minutes and shorter than 20 minutes of the tACS.

18. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that the pause is provided after an increase of a cognitive workload of the user while performing the set of tasks.

19. The brain stimulation system according to claim 1 , wherein the brain stimulation system is configured such that the pause has a duration that is determined by at least one of the following:

the duration that has always the same length, for instance a duration equal to approximately 2 minutes or more, and/or

at least one physiological parameter of the user is again in a normal range, and/or

the user signals that he or she is ready to continue.

Assignments (1)

Priority Claims (1)

Continuity (2)

References Cited (34)