Brain Computer Interface（BCI） System for Stroke Rehabilitation

Study Overview
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Brief Summary
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A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.

Official Title
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Brain Computer Interface（BCI） System for Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Procedure: BCI using EEG signals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment; Subcortical ischemic lesion within the territory of the middle cerebral artery; Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)). Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection. Exclusion Criteria: Severe hand spasticity, open hand wound or hand deformity; Visual field deficits; Aphasia, neglect, and apraxia, Participation in any therapeutic treatment (outside therapy) performed with the paralyzed arm during the planned study - including baseline and follow up. History of alcohol, drug abuse or epilepsy, Bilateral infracts, Uncontrolled medical problems, Serious cognitive deficits, Other MRI contraindications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCI-robot (I)<br>EEG guided training based on ipsilesional EEG signals; Training for 20 sessions | Procedure: BCI using EEG signals<br>* A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.<br>|
| Experimental: BCI-robot (IC)<br>EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions | Procedure: BCI using EEG signals<br>* A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.<br>|
| Placebo Comparator: robot<br>Training for 20 sessions | Procedure: BCI using EEG signals<br>* A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMA-UE |  | 6-month followup | 
| ARAT |  | 6-month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAS |  | 6-month followup | 
| MRI |  | 6-month followup |