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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yihe Wang, Dr.
- Telefonní číslo: +8618810899617
- E-mail: Wangyh9011@163.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100037
- Xuanwu Hospital Capital Medical University
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Kontakt:
- Yihe Wang, Dr.
- Telefonní číslo: 18810899617
- E-mail: Wangyh9011@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
|
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The difference between Hamilton Depression Rating Scale (HAMD) at the end of treatment and the baseline.
Časové okno: 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.
Časové okno: 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
Časové okno: Day 90 after training.
|
EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric. |
Day 90 after training.
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Incidence of Adverse events
Časové okno: From baseline through the Day 90 follow-up visit.
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From baseline through the Day 90 follow-up visit.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BCI-Stroke
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The Steering Committee will consider on a case-by-case basis requests for data sharing.
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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