Efficacy and Circuit Mechanisms of Noninvasive Brain-Computer Interface Therapy for Upper-Extremity Motor Function in Patients With Ischemic Stroke (BRACING)
This prospective, single-center, single-arm exploratory clinicaltrial will enroll participants with upper-extremity dysfunction after chronicischemic stroke. A total of 38 participants are planned. All enrolled participants will receive noninvasive brain-computer interface (BCI)-controlled exoskeleton training for 4 weeks, once daily, 5 days per week. Upper-extremity motor function will be assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), the Action Research Arm Test (ARAT), and other measures. The study aims to: (1) preliminarily evaluate the efficacy of noninvasive BCI-controlled exoskeleton training in promoting upper-extremity motor recovery after chronic ischemic stroke; and (2)use multimodal neuroimaging and electrophysiological techniques to clarify the regulatory role of the reward-motor circuit in BCI-induced motor learning and functional recovery, and to explore key neural biomarkers and predictive models associated with treatment response.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Yihe Wang, Dr.
- 電話番号：+8618810899617
- メール：Wangyh9011@163.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100037
- Xuanwu Hospital Capital Medical University
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コンタクト：
- Yihe Wang, Dr.
- 電話番号：18810899617
- メール：Wangyh9011@163.com
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- First-ever unilateral supratentorial ischemic stroke.
- Stroke onset at least 1 year previously, with stable neurological function duringthe preceding 3 months(increase in total NIHSS score≤2 points).
- Age ≥18 and≤75 years.
- Any sex.
- Unilatera FMA-UE score of 10-45.
- Able to understand simple motor instructions and complete a motor-imagery task; no clinically significant cognitive impairment, defined as MoCA>20 or MMSE>24
- Sitting balance grade I-II,with the ability to maintain a seated position formore than 15 minutes.
- Sufficient comprehension and communication ability, willingness to participate,and signed informed consent.
Exclusion Criteria:
- Previous stroke, ischemic or hemorrhagic.
- Bilateral,cerebellar, or brainstem lesions.
- Severe upper-extremity spasticity(Modifed Ashworth Scale score≥3).
- Unhealed fracture, osteoporosis, joint dislocation, or another condition affecting joint movement.
- Severe depression(Beck Depression Inventory score≥17).
- Marked hemispatial neglect or severe visuospatial impaiment.
- Any MRl contraindication.
- Current participation in another clinical trial.
- Other important comorbidities,such as traumatic brain injury, ankylosing spondylitis, malignant tumor, neurodegenerative disease, epilepsy, multiplesclerosis, severe infection, unstable angina, or severe arrhythmia.
- Pregnancy or breast feeding, or inability to use appropriate contraception during the trial.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：BCI-induced Group
Patients with upper-extremity dysfunction after ischemic stroke. |
All eligible patients with upper-extremity dysfunction after chronic ischemic stroke will receive the study treatment once daily, 5 days per week, for 4 weeks. The intervention uses the BCI system together with the active passive exoskeleton training system. The clinical management platform will be used for participant enrollment, assessment, treatment planning, and data archiving. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
時間枠：Day 90 after training.
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The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function. |
Day 90 after training.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Action Research Arm Test (ARAT) total score ranges from 0 to 57, with higher scores indicating better upper-extremity functional ability. |
Day 90 after training.
|
|
The difference between the Motor Status Scale (MSS) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Motor Status Scale (MSS) total score ranges from 0 to 82, with higher scores indicating better upper-extremity motor function. |
Day 90 after training.
|
|
The difference between the Stroke-Specific Quality of Life Scale (SS-QOL) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Stroke-Specific Quality of Life Scale (SS-QOL) total score ranges from 49 to 245, with higher scores indicating better stroke-specific quality of life. |
Day 90 after training.
|
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The difference between Stroke Rehabilitation Motivation Scale, 7-item version (SRMS-7) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Stroke Rehabilitation Motivation Scale, 7-item version (SRMS-7), total score ranges from 7 to 35, with higher scores indicating greater rehabilitation motivation. |
Day 90 after training.
|
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The difference between Apathy Evaluation Scale-Selfrated (AES-S) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Apathy Evaluation Scale-Self-rated (AES-S) total score ranges from 18 to 72, with higher scores indicating greater apathy and a worse outcome. |
Day 90 after training.
|
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The difference between Temporal Experience of Pleasure Scale (TEPS) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Temporal Experience of Pleasure Scale (TEPS) total score ranges from 18 to 108, with higher scores indicating greater pleasure and less anhedonia. |
Day 90 after training.
|
|
The difference between Hamilton Anxiety Rating Scale (HAMA) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The Hamilton Anxiety Rating Scale (HAMA) total score ranges from 0 to 56, with higher scores indicating greater anxiety severity and a worse outcome. |
Day 90 after training.
|
|
The difference between Hamilton Depression Rating Scale (HAMD) at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) total score ranges from 0 to 52, with higher score. |
Day 90 after training.
|
|
The difference between fMRI/sMRI measures of structural and functional brain changes at the end of treatment and the baseline.
時間枠：Day 90 after training.
|
EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric. |
Day 90 after training.
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The difference between EEG and functional near-infrared spectroscopy (fNIRS) measures at the end of treatment and the baseline, including decoding accuracy, cortical activation, and brain-network topology
時間枠：Day 90 after training.
|
EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric. |
Day 90 after training.
|
その他の成果指標
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Incidence of Adverse events
時間枠：From baseline through the Day 90 follow-up visit.
|
From baseline through the Day 90 follow-up visit.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- BCI-Stroke
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The Steering Committee will consider on a case-by-case basis requests for data sharing.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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