The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.

Study Overview
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Brief Summary
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To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.

Detailed Description
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Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc. In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Official Title
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China National Clinical Research Center for Neurological Diseases

Conditions
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Hemiplegia Following Ischemic Stroke

Intervention / Treatment
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* Device: Brain-computer interface
* Other: Traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (18 years<male or female≤80 years ) Ischemic stroke diagnosed by MRI within 1 month before randomization Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization Informed consent signed Exclusion Criteria: Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness A history of epilepsy Sensory disorders or hallucinations Internal carotid artery dissection or thrombolysis Apraxia Agnosia Other diseases that may interfere with motor function Severe cardiopulmonary disease, severe illness, and unstable vital signs Severe balance dysfunction Participating in other clinical trial During pregnancy and lactation The Numerical Rating Scale (NRS) scores of upper extremities>4.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>brain-computer interface rehabilitation training and traditional rehabilitation training. | Device: Brain-computer interface<br>* brain-computer interface rehabilitation training.<br>Other: Traditional rehabilitation<br>* traditional rehabilitation training.<br>|
| Other: Control group<br>traditional rehabilitation training. | Other: Traditional rehabilitation<br>* traditional rehabilitation training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of upper limb motor function at 1 month after randomization. | Tested by Fugl-Meyer Assessment (FMA) scale. | 1 month after randomization compared with traditional rehabilitation strategy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of upper limb motor function at 3 month after randomization. | Tested by Fugl-Meyer Assessment (FMA) scale. | 3 months after randomization compared with traditional rehabilitation strategy . | 
| The improvement of upper limb motor function at 1, 3 month after randomization. | Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT). | 1, 3 months after randomization compared with traditional rehabilitation strategy. | 
| The improvement in muscle tone at 1, 3 month after randomization. | Tested by the Modified Ashworth scale (MAS). | 1, 3 months after randomization compared with traditional rehabilitation strategy. | 
| The improvement of patients' ability to take care of themselves in daily life | Tested by Instrumental Activity of Daily living (IDAL). | 1, 3 months after randomization compared with traditional rehabilitation strategy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-computer interface, Electric stimulation therapy, Stroke rehabilitation