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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yihe Wang, Dr.
- Telefonnummer: +8618810899617
- E-Mail: Wangyh9011@163.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100037
- Xuanwu Hospital Capital Medical University
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Kontakt:
- Yihe Wang, Dr.
- Telefonnummer: 18810899617
- E-Mail: Wangyh9011@163.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
Zeitfenster: Day 90 after training.
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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.
|
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The difference between the Motor Status Scale (MSS) at the end of treatment and the baseline.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
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The difference between Hamilton Anxiety Rating Scale (HAMA) at the end of treatment and the baseline.
Zeitfenster: 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.
Zeitfenster: 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.
|
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The difference between fMRI/sMRI measures of structural and functional brain changes at the end of treatment and the baseline.
Zeitfenster: 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
Zeitfenster: Day 90 after training.
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EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric. |
Day 90 after training.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Incidence of Adverse events
Zeitfenster: From baseline through the Day 90 follow-up visit.
|
From baseline through the Day 90 follow-up visit.
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BCI-Stroke
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The Steering Committee will consider on a case-by-case basis requests for data sharing.
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