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Efficacy and Circuit Mechanisms of Noninvasive Brain-Computer Interface Therapy for Upper-Extremity Motor Function in Patients With Ischemic Stroke (BRACING)

2026年11月6日 更新者：Xuanwu Hospital, Beijing

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100037
        • Xuanwu Hospital Capital Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：BCI-induced Group

Patients with upper-extremity dysfunction after ischemic stroke.
设备：BCI system together with the active-passive exoskeleton training system

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.

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
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
大体时间：Day 90 after training.

The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Day 90 after training.

次要结果测量

结果测量
措施说明
大体时间
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
大体时间：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.
大体时间：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.
大体时间：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.
The difference between Stroke Rehabilitation Motivation Scale, 7-item version (SRMS-7) at the end of treatment and the baseline.
大体时间：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.
The difference between Apathy Evaluation Scale-Selfrated (AES-S) at the end of treatment and the baseline.
大体时间：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.
The difference between Temporal Experience of Pleasure Scale (TEPS) at the end of treatment and the baseline.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：Day 90 after training.

EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric.
Day 90 after training.
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
大体时间：Day 90 after training.

EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric.
Day 90 after training.

其他结果措施

结果测量
大体时间
Incidence of Adverse events
大体时间：From baseline through the Day 90 follow-up visit.
From baseline through the Day 90 follow-up visit.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Xuanwu Hospital, Beijing

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月31日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2028年10月31日

研究注册日期

首次提交

2026年10月21日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BCI-Stroke

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The Steering Committee will consider on a case-by-case basis requests for data sharing.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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