Brain Computer Interface（BCI） System for Stroke Rehabilitation

September 15, 2017 updated by: Raymond KY Tong, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCI-robot (I)
EEG guided training based on ipsilesional EEG signals; Training for 20 sessions
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.
Experimental: BCI-robot (IC)
EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions
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.
Placebo Comparator: robot
Training for 20 sessions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FMA-UE
Time Frame: 6-month followup
6-month followup
ARAT
Time Frame: 6-month followup
6-month followup

Secondary Outcome Measures

Outcome Measure
Time Frame
MAS
Time Frame: 6-month followup
6-month followup
MRI
Time Frame: 6-month followup
6-month followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4055037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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