Clinical trial NCT06432907: StereoEEG Motor Neuronal Potentials Decoding
Official title: Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Brain-Computer Interfaces
Keywords: Brain-Computer Interface
Motor Imagery
Motor Performance
Intracranial Electroencephalography
Lead sponsor: Research Center of Neurology, Russia
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Higher Nervous Activity and Neurophysiology of RAS
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of this study are (1) to evaluate the rate of stereoEEG brain-computer interface (BCI) classification accuracy and (2) to collect the dataset of neuronal signals recorded from stereoEEG electrodes during motor performance, motor imagery or brain-computer interface control. The study enrolls hospitalised patients suffering from resistant epilepsy with already implanted intracranial stereoEEG electrodes for medical reasons (i.e. for preoperative localization of the epileptogenic foci). The number and location of electrodes are determined solely for the clinical purposes of stereoEEG monitoring and are not related to the protocol of the current study.

After obtaining informed consent to participate in the study, each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and BCI control. All tasks and instructions presented during the study session are not pro-epileptogenic and cannot provoke an epileptic attack. The experiments will take place in the patient's room, without interruption of observation by the department's medical staff.

The data recorded in this study will be used to improve or develop new algorithms for decoding motor signals from deep brain structures for their potential use in invasive BCIs.


Eligibility criteria: Inclusion Criteria:

* male and female patients who have had stereoEEG electrodes implanted for medical reasons;
* voluntary informed consent to participate in the study;
* age from 18 to 70 years.

Exclusion Criteria:

* patient refusal to participate in the study;
* cognitive impairment that prevents following the study instructions;
* severe visual impairment that does not allow viewing visual instructions on a computer screen;
* upper limb paresis or other motor disorders;
* pain in the hand of any etiology;
* any acute diseases, exacerbation of chronic diseases, acute life-threatening conditions;
* occurrence of an epileptic attack during the experiment.

Primary outcomes:
measure: Rate of BCI classification recall
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research center of neurology, Department of neurorehabilitation and physiotherapy
Study officials:
References: