Not Yet RecruitingNot Applicable

Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction

China66 participantsStarted 2026-09

Plain-language summary

This clinical study aims to evaluate the efficacy and safety of spinal cord stimulation combined with non-invasive motor imagery brain-computer interface rehabilitation training in patients with upper limb motor dysfunction after chronic stroke. The study includes an experimental group receiving spinal cord stimulation combined with motor imagery brain-computer interface rehabilitation training and a control group receiving motor imagery brain-computer interface rehabilitation training alone. The primary outcome is upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity. Secondary outcomes include muscle tone, upper limb functional activity, activities of daily living, adverse events, serious adverse events, and exploratory neurophysiological and neuroimaging indicators.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 75 years. * First-ever unilateral supratentorial stroke, either ischemic or hemorrhagic, confirmed by computed tomography or magnetic resonance imaging, resulting in hemiparesis, with disease duration longer than 6 months. * At least one active movement in the wrist or fingers of the affected upper limb, with muscle strength of grade 1 or higher. * Fugl-Meyer Assessment for Upper Extremity score between 10 and 40, indicating moderate upper limb motor impairment. * Change in Fugl-Meyer Assessment score less than 10% within the previous month, indicating a functional plateau. * Clear consciousness and basically normal cognitive function, with Mini-Mental State Examination score of 24 or higher. * Stable clinical condition and ability to understand and cooperate with simple instructions and rehabilitation training. * Written informed consent voluntarily signed by the participant or legal guardian. Exclusion Criteria: * Other neurological diseases that may cause motor dysfunction, such as Parkinson's disease, multiple sclerosis, or spinal cord injury. * Severe visual or auditory impairment that prevents cooperation with visual or auditory feedback instructions of the brain-computer interface system. * Contraindications to spinal cord stimulation surgery, such as severe coagulation dysfunction, infection at the puncture site, severe spinal deformity, or spinal canal stenosis. * History of epilepsy, intracranial metal implants, cardiac pacemaker, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines spinal cord stimulation with a brain-computer interface using motor imagery — can you explain what each of those components actually involves day-to-day, and whether my current level of upper limb function would make me a realistic candidate to discuss?
2Since this trial is listed as 'not yet recruiting,' how would we stay informed about when it opens, and is there anything I should be doing in the meantime to preserve or improve my upper limb function while we wait?
3The trial is labeled Phase NA, which I understand can mean it's a device or procedure study rather than a drug trial — what does that mean for how much safety and effectiveness data already exists for combining spinal cord stimulation with a brain-computer interface in stroke patients?
4The main thing being measured is change in the Fugl-Meyer Upper Extremity Score — can you help me understand what a meaningful improvement on that scale would actually look like in terms of real daily tasks, like gripping or reaching?
5Are there standard rehabilitation approaches or other existing treatments for chronic post-stroke upper limb dysfunction that I should consider trying first, or alongside keeping this trial as an option?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fugl-Meyer Assessment for Upper Extremity Score

Timeframe: Baseline, Week 4, Week 8, and Week 12

Trial details

NCT IDNCT07686822

SponsorZhejiang Provincial People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Faliang Gao, PhD

+86-571-85893451 gaofaliang1985@126.com

View on ClinicalTrials.gov More Chronic Stroke trials