StereoEEG Motor Neuronal Potentials Decoding

NCT ID: NCT06432907

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2026-12-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

StereoEEG

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.

Group Type: EXPERIMENTAL

motor tasks

Intervention Type: 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.

Interventions

motor tasks

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.

Intervention Type: OTHER

Other Intervention Names

motor execution, motor imagery, brain-computer interface control with motor imagery paradigm

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Higher Nervous Activity and Neurophysiology of RAS

UNKNOWN

Sponsor Role: collaborator

Research Center of Neurology, Russia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research center of neurology, Department of neurorehabilitation and physiotherapy

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Olesya A Mokienko, MD PhD

Role: CONTACT

lesya.md@yandex.ru

+74953747776

Roman Kh Lyukmanov, MD PhD

Role: CONTACT

xarisovich@gmail.com

+74953747776

Facility Contacts

Natalia A Suponeva, MD

Role: primary

nasu2709@mail.ru

+79161894988

Other Identifiers

Stereo-iBCI

Identifier Type: -

Identifier Source: org_study_id