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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Spinal Cord Stimulation
  • Motor Imagery Brain-Computer Interface Rehabilitation Training

Treatment groups

66 Participants
are divided into 2 treatment groups