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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)

6 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

38

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100037
        • Xuanwu Hospital Capital Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BCI-induced Group

Patients with upper-extremity dysfunction after ischemic stroke.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: Day 90 after training.

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

Andra resultatmått

Resultatmått
Tidsram
Incidence of Adverse events
Tidsram: From baseline through the Day 90 follow-up visit.
From baseline through the Day 90 follow-up visit.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Xuanwu Hospital, Beijing

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 oktober 2026

Primärt slutförande (Beräknad)

31 oktober 2027

Avslutad studie (Beräknad)

31 oktober 2028

Studieregistreringsdatum

Först inskickad

21 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

6 november 2026

Första postat (Faktisk)

9 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BCI-Stroke

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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