Granted Patent B2

US 12,646,603 · App. 17/428,903 · Granted Jun 2, 2026

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 (122)

1 . A brain stimulation system comprising:

a) a computer program product comprising program code (P 1 , P 1 a ) 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 (P 1 , P 1 a ) loaded on the electronic control unit, wherein the program code (P 1 , P 1 a ), 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 stimulation session for a brain, wherein the brain training and stimulation session comprises a task performance and a stimulation of the 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 task is presented during the brain training and stimulation session, 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 cognitive load/workload experienced by the user during the brain training and stimulation session whether the task performance and the stimulation of the brain training and stimulation session is continued or whether the task performance and the stimulation of the brain training and stimulation session is interrupted only temporarily to avoid excessive cognitive load/workload for the user,

wherein the system is configured such that in case of a temporary interruption, no task is presented to the user by the brain stimulation system, and

wherein a duration of the temporary interruption is determined by at least one physiological parameter of the user being again in a normal range.

2 . The brain stimulation system of claim 1 ,

wherein the stimulation functionality comprises a preparation stimulation functionality for a preparation stimulation and/or a task stimulation functionality for a task stimulation,

wherein the preparation stimulation is configured to be performed before the task is presented to the user and/or the task stimulation is configured to be synchronized with the presentation of the task.

3 . The brain stimulation system of claim 2 ,

wherein the type of stimulation in the stimulation procedure is specified in the stimulation command to be transcranial alternating current stimulation mode,

wherein the frequency of the transcranial alternating current stimulation is in the range of 70 Hz (Hertz) to 80 Hz.

4 . The brain stimulation system of claim 3 , wherein the frequency is 75 Hz.

5 . The brain stimulation system of claim 1 ,

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

6 . The brain stimulation system of claim 1 ,

wherein the operation control system is configured such that, during the brain training and stimulation session, a plurality of presentation commands is issued to present different tasks on the user interface during the brain training and stimulation session but only one preparation stimulation is performed.

7 . 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.

8 . 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 of the performance of a task by the user,

wherein the performance assessment functionality considers at least one or both of the following:

accuracy of performance of the task,

duration of performance of the task.

9 . The brain stimulation system of claim 8 ,

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 the user-specific performance data related to the user, wherein the feedback is one of, any arbitrarily selected plurality of, or all of:

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

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

a feedback at the beginning of a subsequent brain training and stimulation session,

wherein the respective feedback is performance-indicative and/or performance-dependent feedback.

10 . The brain stimulation system of claim 8 , wherein the performance assessment functionality considers the number of mistakes.

11 . The brain stimulation system of claim 10 , wherein the performance assessment functionality considers at least one of:

the selection of incorrect words,

the number of typographical errors.

12 . The brain stimulation system of claim 8 , wherein the duration of performance of the task considers how long it has taken for the user to perform a single task.

13 . 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 stimulation session or a subsequent brain training and stimulation session for the same user.

14 . The brain stimulation system of claim 1 ,

wherein the user condition monitoring functionality is configured to determine based on user condition data indicative for the current cognitive load/workload experienced by the user and based on user condition data comprising one or more physiological parameters of the user which are monitored by the brain stimulation system, during the brain training and stimulation session whether the brain training and stimulation session is continued with the presentation of a task, or whether the brain training and stimulation session is stopped or interrupted to avoid excessive cognitive load/workload for the user, wherein, if the brain training and 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 end, or to interrupt the brain training and stimulation session.

15 . 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 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 stimulation session;

and wherein the session number tracking functionality is used for billing or accounting the service that is supplied by the brain stimulation system.

16 . 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 stimulation session to a remote location device, such as to a remote computer or a data storage, wherein the session data 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 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 stimulation session,

user-specific data comprising information on the user which is or was subject to the brain training and 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 performance of the specific task by user,

session-specific data,

wherein the telemetry or transmission functionality is configured to transmit the session data during brain training and stimulation session or only thereafter.

17 . 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 the current signal for the 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 stimulation session but before presentation of the task;

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

duration of the electrical brain stimulation procedure;

start of the electrical brain stimulation procedure.

18 . The brain stimulation system of claim 1 ,

wherein the operation control system comprises a session operation protocol interface functionality which is configured to receive user-specific session operation data for the brain training and 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 session,

data on whether a task stimulation is to be performed during the session,

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

data on the difficulty of the task(s) 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 that user who is made or will be made subject to the brain training and stimulation session.

19 . The brain stimulation system of claim 1 ,

wherein the task is a task related to language comprehension and/or language production, and/or

wherein the operation control system comprises a control functionality that is part of the link or that forms the link between stimulation functionality and presentation functionality.

20 . The brain stimulation system of claim 1 ,

wherein the user condition monitoring functionality is configured to determine based on user condition data comprising one or more physiological parameters of the user which may give indication of the current cognitive load/workload of the user during the brain training and stimulation session whether the brain training and stimulation session is continued or whether the brain training and stimulation session is stopped or interrupted to avoid excessive cognitive load/workload for the user.

21 . The brain stimulation system of claim 1 , comprising the brain stimulation device configured to stimulate a human brain, electrically and transcranially, wherein the brain stimulation device is configured to be mounted on a head of a user for a brain training and stimulation session, and wherein the brain stimulation device is configured to be operated to stimulate the brain via varying, especially alternating, current stimulation in a varying current mode of operation and/or via constant current stimulation in a constant current mode of operation in a stimulation procedure;

wherein:

a) in the alternating current mode of operation, a frequency or range of frequencies of the alternating current used to stimulate the brain is adjusted or adjustable to a frequency which is characteristic for the brain rhythm that occurs while performing a treatment task in an area of the brain which is to be stimulated via alternating current, and/or

b) the brain stimulation device further comprises a device controller, wherein the device controller is configured to select the mode of operation-varying current mode of operation or constant current mode of operation—for the stimulation procedure and/or to set one or more stimulation parameters such that the respective stimulation procedure is performed according to the stimulation parameters, and/or

c) the brain stimulation device has a wireless interface for operative connection of the device to an electronic control unit, and/or

d) wherein, during operation of the brain stimulation device, the device is configured to stimulate, electrically and transcranial, a specific brain area or areas, related to treated function comprising Wernicke's area and/or Broca's area for speech therapy, wherein the respective area or areas can be stimulated via constant current mode and/or varying current mode.

22 . 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 indicative for the cognitive load/workload of the user.

23 . A brain stimulation system comprising:

a) a computer program product comprising program code (P 1 , P 1 a ) 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 (P 1 , P 1 a ) loaded on the electronic control unit, wherein the program code (P 1 , P 1 a ), 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 stimulation session for a brain, wherein the brain training and stimulation session comprises a task performance and a stimulation of the 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 task is presented during the brain training and stimulation session, 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 cognitive load/workload experienced by the user during the brain training and stimulation session whether the task performance and the stimulation of the brain training and stimulation session is continued or whether the task performance and the stimulation of the brain training and stimulation session is interrupted only temporarily to avoid excessive cognitive load/workload for the user,

wherein the system is configured such that in case of a temporary interruption, no task is presented to the user by the brain stimulation system,

wherein a cognitive load/workload level is analyzed,

wherein it is checked whether a specific cognitive load/workload level is exceeded, and

wherein the temporary interruption is provided if the check indicates that the specific cognitive load/workload level is exceeded.

24 . The brain stimulation system of claim 23 , wherein a cognitive load/workload level is analyzed during the temporary interruption,

wherein the duration of the temporary interruption is determined based on determination if at least one physiological parameter of the user is or at least one parameter related to cognitive load/workload of the user is again in a normal range.

25 . The brain stimulation system of claim 24 , wherein the duration of the temporary interruption is determined based on determination if the at least one physiological parameter is or the at least one parameter related to cognitive load/workload is again below at least one threshold that is set for the user or that is user dependent.

26 . A method for treating aphasia, the method comprising the following steps:

a) providing to a patient a task to be performed by the patient, the patient suffering from aphasia; and

b) stimulating one area or more areas of the patient's brain areas involved in language comprehension and/or language production, using varying current mode while the patient is performing the task and/or while the task is presented to the patient, further comprising the step of:

using a brain stimulation system comprising:

a) a computer program product comprising program code (P 1 , P 1 a ) 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 (P 1 , P 1 a ) loaded on the electronic control unit, wherein the program code (P 1 , P 1 a ), 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 stimulation session for a brain, wherein the brain training and stimulation session comprises task performance and stimulation of the 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;

wherein a frequency of a transcranial alternating current stimulation used for the brain stimulation procedure is in the range of 70 Hz (Hertz) to 80 Hz; 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 task is presented during the brain training and stimulation session, 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 cognitive load/workload experienced by the user during the brain training and stimulation session whether the task performance and the stimulation of the brain training and stimulation session is continued or whether the task performance and the stimulation of the brain training and stimulation session is interrupted only temporarily to avoid excessive cognitive load/workload for the user,

wherein the system is configured such that in case of a temporarily interruption no task is presented to the user by the brain stimulation system, and

wherein a duration of the temporary interruption is determined by at least one physiological parameter of the user being again in a normal range.

27 . The method according to claim 26 , 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,

wherein the performance assessment functionality considers at least one or both of the following:

accuracy of performance of the task,

duration of performance of the task, and

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 the user-specific task performance data related to the user, wherein the feedback is one of, any arbitrarily selected plurality of, or all of:

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

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

a feedback at the beginning of a subsequent brain training and stimulation session,

wherein the respective feedback is performance-indicative and/or performance-dependent feedback.

28 . The method according to claim 27 , wherein the performance assessment functionality considers a number of mistakes.

29 . The method according to claim 28 , wherein the performance assessment functionality considers at least one of:

a selection of incorrect words,

a number of typographical errors.

30 . The method according to claim 27 , wherein the duration of performance of the task considers how long it has taken for the user to perform a single task.

Assignments (2)

Priority Claims (1)

Continuity (1)

References Cited (34)