Brain Computer Interface（BCI） System for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Brain Computer Interface（BCI） System for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323061
• Other study ID #: 4055037
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: September 15, 2017
• Start date: May 1, 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• BCI using EEG signals
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.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMA-UE		6-month followup
Primary	ARAT		6-month followup
Secondary	MAS		6-month followup
Secondary	MRI		6-month followup