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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.
Upper limb motor dysfunction is a common and disabling sequela of stroke. Many patients enter a chronic phase more than 6 months after stroke onset, during which spontaneous recovery and conventional rehabilitation-related improvement often reach a plateau. Motor imagery brain-computer interface rehabilitation can decode motor intention from electroencephalographic signals and provide closed-loop feedback through external devices, thereby promoting cortical reorganization. However, in patients with impaired corticospinal pathways and insufficient residual motor execution capacity, the efficacy of motor imagery brain-computer interface training alone may be limited.
Spinal cord stimulation may facilitate spinal motor circuits, reduce abnormal muscle tone, and improve the excitability of residual descending motor pathways. Combining spinal cord stimulation with motor imagery brain-computer interface training may provide a synergistic central-peripheral neuromodulation strategy. The brain-computer interface decodes motor intention from the central nervous system, while spinal cord stimulation facilitates peripheral motor pathway execution, potentially enhancing motor recovery and neuroplasticity.
Participants will be assigned, according to patient preference and investigator assessment, to either the experimental group or the control group. The experimental group will undergo spinal cord stimulation implantation followed by individualized stimulation programming and standardized motor imagery brain-computer interface rehabilitation training. The control group will receive the same frequency and duration of motor imagery brain-computer interface rehabilitation training without spinal cord stimulation implantation. Clinical outcomes will be assessed at baseline, after 4 weeks of intervention, 2 months after intervention, and 3 months after intervention. Safety events will be recorded throughout the study. Exploratory assessments will include electroencephalography and neuroimaging to investigate potential mechanisms of neuroplasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training | Experimental | Participants in this group will undergo spinal cord stimulation implantation followed by individualized stimulation programming. After stabilization of stimulation parameters, participants will receive standardized motor imagery brain-computer interface rehabilitation training for 4 weeks, 5 sessions per week. |
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| Motor Imagery Brain-Computer Interface Rehabilitation Training | Active Comparator | Participants in this group will receive the same frequency and duration of standardized motor imagery brain-computer interface rehabilitation training as the experimental group, for 4 weeks, 5 sessions per week. Training equipment, motor imagery tasks, and feedback methods will be consistent with those used in the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Spinal 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 8, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Ashworth Scale Score | The Modified Ashworth Scale will be used to assess muscle tone and spasticity of the affected upper limb. | Baseline, Week 4, Week 8, and Week 12 |
| Change in Action Research Arm Test Score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, and Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faliang Gao, PhD | Contact | +86-571-85893451 | gaofaliang1985@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
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| Motor Imagery Brain-Computer Interface Rehabilitation Training | Device | Motor 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. |
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The Action Research Arm Test will be used to assess functional activity of the affected upper limb, including grasp, grip, pinch, and gross movement.
| Baseline, Week 4, Week 8, and Week 12 |
| Change in Modified Barthel Index Score | The Modified Barthel Index will be used to assess activities of daily living. | Baseline, Week 4, Week 8, and Week 12 |
| 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. | From enrollment to Week 12 |
| 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. |
| Baseline and Week 12 |
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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