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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Faliang Gao, PhD
- 电话号码：+86-571-85893451
- 邮箱：gaofaliang1985@126.com
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310014
- Zhejiang Provincial People's Hospital
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接触：
- Faliang Gao, PhD
- 电话号码：+86-571-85893451
- 邮箱：gaofaliang1985@126.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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, or other contraindications to magnetic resonance imaging.
- Previous neuromodulation surgery for hemiparesis, such as spinal cord stimulation or deep brain stimulation.
- Pregnancy or lactation.
- Any other condition judged by the investigator to make the participant unsuitable for this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training
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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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.
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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有源比较器：Motor Imagery Brain-Computer Interface Rehabilitation Training
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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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Fugl-Meyer Assessment for Upper Extremity Score
大体时间：Baseline, Week 4, Week 8, and Week 12
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The Fugl-Meyer Assessment for Upper Extremity will be used to evaluate motor function recovery of the affected upper limb.
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Baseline, Week 4, Week 8, and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Modified Ashworth Scale Score
大体时间：Baseline, Week 4, Week 8, and Week 12
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The Modified Ashworth Scale will be used to assess muscle tone and spasticity of the affected upper limb.
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Baseline, Week 4, Week 8, and Week 12
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Change in Action Research Arm Test Score
大体时间：Baseline, Week 4, Week 8, and Week 12
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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.
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Baseline, Week 4, Week 8, and Week 12
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Change in Modified Barthel Index Score
大体时间：Baseline, Week 4, Week 8, and Week 12
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The Modified Barthel Index will be used to assess activities of daily living.
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Baseline, Week 4, Week 8, and Week 12
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Incidence of Adverse Events and Serious Adverse Events
大体时间：From enrollment to Week 12
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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.
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From enrollment to Week 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Change in Electroencephalographic Indicators
大体时间：Baseline, Week 4, and Week 12
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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.
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Baseline, Week 4, and Week 12
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Change in Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Indicators
大体时间：Baseline and Week 12
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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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Baseline and Week 12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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