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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Rehabilitation; Brain Computer Interface
• Intervention / Treatment: Device: BCI system together with the active-passive exoskeleton training system

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihe Wang, Dr.; Phone Number: +8618810899617; Email: Wangyh9011@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Xuanwu Hospital Capital Medical University
      • Contact: Yihe Wang, Dr.; Phone Number: 18810899617; Email: Wangyh9011@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BCI-induced Group; Patients with upper-extremity dysfunction after ischemic stroke.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score	The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.	Day 90 after training.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.	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.	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.	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.	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.	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.	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.	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.	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.	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	EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric.	Day 90 after training.

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse events	From baseline through the Day 90 follow-up visit.

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: October 21, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Brain computer interface
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: BCI-Stroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No