ClinicalTrials.gg
Not yet recruitingNCT07924683BRACINGUpdated Nov 9, 2026

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

An interventional study of BCI system together with the active-passive exoskeleton training system in Stroke, Rehabilitation and Brain Computer Interface, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stroke
  • Rehabilitation
  • Brain Computer Interface

Browse trials for

Keywords

  • Stroke
  • Rehabilitation
  • Brain computer interface
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 38 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 cognitive impairment, defined as >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 .

Exclusion criteria

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 .
  • 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 during the trial.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    BCI-induced Group

    Patients with upper-extremity dysfunction after ischemic stroke.

    Device: BCI system together with the active-passive exoskeleton training system

Interventions

  • DeviceBCI 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 90 after training.

Secondary outcomes

  1. 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.

    Time frame: Day 90 after training.

  2. 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.

    Time frame: Day 90 after training.

  3. 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.

    Time frame: Day 90 after training.

  4. 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.

    Time frame: Day 90 after training.

  5. 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.

    Time frame: Day 90 after training.

  6. 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.

    Time frame: Day 90 after training.

  7. 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.

    Time frame: Day 90 after training.

  8. 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.

    Time frame: Day 90 after training.

  9. 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.

    Time frame: Day 90 after training.

  10. 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.

    Time frame: Day 90 after training.

Other outcomes

  1. Incidence of Adverse events

    Time frame: From baseline through the Day 90 follow-up visit.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — The Steering Committee will consider on a case-by-case basis requests for data sharing.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924683
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

Yihe Wang, Dr.
Contact
Wangyh9011@163.com
+8618810899617

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion