Brain Computer Interface（BCI） System for Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: BCI using EEG signals

• Registration Number: NCT02323061
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-23
• Study Start: 2015-05-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
2. Subcortical ischemic lesion within the territory of the middle cerebral artery;
3. 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)).
4. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.

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Exclusion Criteria

1. Severe hand spasticity, open hand wound or hand deformity;
2. Visual field deficits;
3. Aphasia, neglect, and apraxia,
4. Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
5. History of alcohol, drug abuse or epilepsy,
6. Bilateral infracts,
7. Uncontrolled medical problems,
8. Serious cognitive deficits,
9. Other MRI contraindications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCI-robot (IC)	BCI using EEG signals	EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions
BCI-robot (I)	BCI using EEG signals	EEG guided training based on ipsilesional EEG signals; Training for 20 sessions
robot	BCI using EEG signals	Training for 20 sessions

Primary Outcome Measures

Name	Time	Method
ARAT	6-month followup
FMA-UE	6-month followup

Secondary Outcome Measures

Name	Time	Method
MRI	6-month followup
MAS	6-month followup

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong