Drug Resistant EpilepsyNCT06432907
StereoEEG Motor Neuronal Potentials Decoding
A study testing motor tasks in people with Drug Resistant Epilepsy and Brain-Computer Interfaces, run by Research Center of Neurology, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug Resistant Epilepsy, Brain-Computer Interfaces
- What is being tested?
- motor tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 6 Jun 2024to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Research center of neurology, Department of neurorehabilitation and physiotherapy
Moscow, 125367
Natalia A Suponeva, MD, +79161894988, nasu2709@mail.ru
Olesya A Mokienko, MD PhD
About this study
Official title: Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes
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
- Being tested
- motor tasks
- Keywords
- Brain-Computer Interface, Motor Imagery, Motor Performance, Intracranial Electroencephalography
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor tasksOther
Also called motor execution, motor imagery, brain-computer interface control with motor imagery paradigm
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: motor tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BCI classification recall
The proportion (%) of cases with correct identification of the task among all presentations of the corresponding command.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start6 Jun 2024
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center of Neurology, Russia
- Sponsor type
- Other government
- Collaborators
- Institute of Higher Nervous Activity and Neurophysiology of RAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432907
- Sponsor's protocol ID
- Stereo-iBCI
- Status last verified
- Jul 2025
- First submitted
- 6 May 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes
- ClinicalTrials.gov ID
- NCT06432907
- Acronym / sponsor ID
- Stereo-iBCI
- Conditions
- Drug Resistant Epilepsy, Brain-Computer Interfaces
- Keywords
- Brain-Computer Interface, Motor Imagery, Motor Performance, Intracranial Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Research Center of Neurology, RussiaOther government
- Collaborators
- Institute of Higher Nervous Activity and Neurophysiology of RAS
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StereoEEG | Experimental | Other: motor tasksEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor tasksAlso: motor execution, motor imagery, brain-computer interface control with motor imagery paradigmDuring 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. | Other | StereoEEG |
Primary outcome
Rate of BCI classification recall
Time frame: During the procedure
The proportion (%) of cases with correct identification of the task among all presentations of the corresponding command.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor tasks in people with Drug Resistant Epilepsy and Brain-Computer Interfaces, run by Research Center of Neurology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olesya A Mokienko, MD PhD (+74953747776, lesya.md@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of BCI classification recall (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.