StereoEEG Motor Neuronal Potentials Decoding

NCT06432907 | Recruiting

• 1 other identifier: Stereo-iBCI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistant Epilepsy; Brain-Computer Interfaces

Keywords

Brain-Computer Interface; Motor Imagery; Motor Performance; Intracranial Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Rate of BCI classification recall

  The proportion (%) of cases with correct identification of the task among all presentations of the corresponding command.

  During the procedure

Study Arms (1)

StereoEEG

EXPERIMENTAL

Each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and brain-computer interface (BCI) control.

Other: motor tasks

Interventions

motor tasks OTHER

During the study session, the patient will sit at a table in front of a computer monitor. The stereoEEG electrodes will be connected to the Neurovisor-BMM52 electroencephalograph (Medical Computer Systems, Russia) and to a computer with a software for recording and decoding brain signals (BCI classifier). One microsensor (Ascension TrekStar, Ascension Technology, USA) and two disposable cutaneous electrodes (connected to the Neurovisor-BMM52 system) will be put on each patient's hand for electromyogram recording. The session consists from 3 blocks (1-3). The participant is asked to: 1. execute simple motor tasks (thumbs up, open hand or clench hand into fist - 30 times with each hand with 5-second brakes), according to the instruction on the computer screen; 2. to imagine the same movements - 30 times with each hand with 5-second brakes; 3. to imagine the same movements with the feedback (brain-computer interface control). The blocks are separated by 5-minute brakes.

Also known as: motor execution, motor imagery, brain-computer interface control with motor imagery paradigm

StereoEEG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Center of Neurology, Russia: lead
• Institute of Higher Nervous Activity and Neurophysiology of RAS: collaborator

Study Sites (1)

Research center of neurology, Department of neurorehabilitation and physiotherapy

Moscow, 125367, Russia

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Olesya A Mokienko, MD PhD

CONTACT

+74953747776; lesya.md@yandex.ru

Roman Kh Lyukmanov, MD PhD

CONTACT

+74953747776; xarisovich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 29, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

RU (1)