Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction
2026年6月30日 更新者：Zhejiang Provincial People's Hospital
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
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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
66
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Faliang Gao, PhD
- 電話番号：+86-571-85893451
- メール：gaofaliang1985@126.com
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、310014
- Zhejiang Provincial People's Hospital
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コンタクト：
- Faliang Gao, PhD
- 電話番号：+86-571-85893451
- メール：gaofaliang1985@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Fugl-Meyer Assessment for Upper Extremity Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Modified Ashworth Scale Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Electroencephalographic Indicators
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年2月1日
研究の完了 (推定)
2028年5月1日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年6月30日
最初の投稿 (実際)
2026年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年6月30日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
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その他の研究ID番号
- KY2026089
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