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.
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.
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.
Parallel
Spinal Cord Stimulation
DeviceSpinal cord stimulation will be delivered through epidural electrodes implanted at cervical spinal cord levels, typically C3-C7 for upper limb dysfunction. Stimulation parameters will be individually optimized within clinically safe and device-permitted ranges, including frequency, pulse width, amplitude, electrode configuration, and stimulation mode.
Motor Imagery Brain-Computer Interface Rehabilitation Training
DeviceMotor imagery brain-computer interface training will use a 64-channel medical-grade electroencephalography cap to acquire scalp EEG signals. Participants will perform motor imagery tasks involving the affected upper limb, such as grasping, elbow extension, or wrist lifting. Sensorimotor rhythm features, especially mu rhythm and beta rhythm event-related desynchronization, will be extracted in real time. When significant event-related desynchronization is detected, the system will trigger external feedback, such as a soft robotic glove or functional electrical stimulation, to assist the affected limb in completing the target movement.
Change in Fugl-Meyer Assessment for Upper Extremity Score
The Fugl-Meyer Assessment for Upper Extremity will be used to evaluate motor function recovery of the affected upper limb.
Change in Modified Ashworth Scale Score
The Modified Ashworth Scale will be used to assess muscle tone and spasticity of the affected upper limb.
Change in Action Research Arm Test Score
The Action Research Arm Test will be used to assess functional activity of the affected upper limb, including grasp, grip, pinch, and gross movement.
Change in Modified Barthel Index Score
The Modified Barthel Index will be used to assess activities of daily living.
Incidence of Adverse Events and Serious Adverse Events
All adverse events and serious adverse events will be recorded and assessed throughout the study. Spinal cord stimulation-related adverse events may include intraoperative or postoperative bleeding, infection, cerebrospinal fluid leakage, electrode migration or fracture, implant rejection, postoperative pain, and neurological injury. Motor imagery brain-computer interface-related adverse events may include dizziness, visual fatigue, skin allergy related to electrode gel, training-related fatigue, and other discomfort.
Change in Electroencephalographic Indicators
Resting-state and motor imagery task-state 64-channel electroencephalography will be collected to analyze event-related desynchronization/synchronization, phase-lag-index-based functional connectivity, and graph-theoretical topological properties.
Change in Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Indicators
Resting-state functional magnetic resonance imaging and diffusion tensor imaging will be performed to assess changes in functional connectivity of the default mode network and sensorimotor network, as well as fractional anisotropy and mean diffusivity of major white matter tracts, including the corticospinal tract.
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