NCT07686822Not yet recruiting
Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction
A Prospective, Single-Center, Non-Randomized, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Spinal Cord Stimulation Combined With Non-Invasive Motor Imagery Brain-Computer Interface Rehabilitation Training for Upper Limb Motor Dysfunction in Patients With Chronic Stroke
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Stroke
- NCT number
- NCT07686822
What you commit to
- Study type: Interventional
- Planned participants: 66
- From Sept 2026 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous neuromodulation surgery for hemiparesis, such as spinal cord stimulation or deep brain stimulation.
Other illness
- 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, or other contraindications to magnetic resonance imaging.
- Any other condition judged by the investigator to make the participant unsuitable for this study.
Other
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.