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Recruiting NCT06432907

StereoEEG Motor Neuronal Potentials Decoding

No phase Interventional Drug Resistant Epilepsy Brain-Computer Interfaces

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: motor tasks.
Who it may be relevant to
Registry conditions: Drug Resistant Epilepsy, Brain-Computer Interfaces. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 electro

Primary outcome measures

  • Rate of BCI classification recall [Time frame: During the procedure]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Russia · 1 center
  • Research center of neurology, Department of neurorehabilitation and physiotherapy — Moscow

Identifiers

NCT: NCT06432907 · Stereo-iBCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗