StereoEEG Motor Neuronal Potentials Decoding

Drug Resistant Epilepsy Clinical Trial

Official title:

Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432907
• Other study ID #: Stereo-iBCI
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: December 25, 2026

Study information

• Verified date: June 2024
• Source: Research Center of Neurology, Russia
• Contact: Olesya A Mokienko, MD PhD
• Phone: +74953747776
• Email: lesya.md[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 25, 2026
• Est. primary completion date: December 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy

Intervention

Other:
• 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: 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; to imagine the same movements - 30 times with each hand with 5-second brakes; to imagine the same movements with the feedback (brain-computer interface control). The blocks are separated by 5-minute brakes.

Locations

Country	Name	City	State
Russian Federation	Research center of neurology, Department of neurorehabilitation and physiotherapy	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Research Center of Neurology, Russia	Institute of Higher Nervous Activity and Neurophysiology of RAS

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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