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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yihe Wang, Dr.
- Número de teléfono: +8618810899617
- Correo electrónico: Wangyh9011@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100037
- Xuanwu Hospital Capital Medical University
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Contacto:
- Yihe Wang, Dr.
- Número de teléfono: 18810899617
- Correo electrónico: Wangyh9011@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The difference between the FMA-UE score at the end of treatment and the baseline FMA-UE score
Periodo de tiempo: Day 90 after training.
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The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function. |
Day 90 after training.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The difference between the Action Research Arm Test (ARAT) at the end of treatment and the baseline.
Periodo de tiempo: 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.
Periodo de tiempo: Day 90 after training.
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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.
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The difference between the Stroke-Specific Quality of Life Scale (SS-QOL) at the end of treatment and the baseline.
Periodo de tiempo: Day 90 after training.
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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.
Periodo de tiempo: Day 90 after training.
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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.
Periodo de tiempo: Day 90 after training.
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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.
Periodo de tiempo: Day 90 after training.
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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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: Day 90 after training.
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EEG and fNIRS measures depend on the prespecified electrophysiological or hemodynamic metric. |
Day 90 after training.
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of Adverse events
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BCI-Stroke
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The Steering Committee will consider on a case-by-case basis requests for data sharing.
Información sobre medicamentos y dispositivos, documentos del estudio
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