Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke

July 4, 2016 updated by: Raymond KY Tong, Chinese University of Hong Kong
In this project we will design a control algorithm to identify the focalized motor-related clusters for hand function on each stroke patient. A real-time feedback will control the robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot training will be compared in a randomized controlled trial to evaluate the training effectiveness and changes in the EEG patterns.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

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
        • Recruiting
        • Division of Biomedical Engineering, Dept Electronic Engineering
        • Contact:
          • Raymond Tong, PhD
          • Phone Number: +852 3943 8454

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

No

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 (Mini-Mental State Examination (MMSE) score>25) ; (2) subcortical location of the 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-Meyer Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test (ARAT))

Exclusion Criteria:

(1) severe hand spasticity, open hand wound or hand deformity; (2) visual field deficits; (3) aphasia, neglect, and apraxia.

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: fBCI-robot
focalized BCI-robot hand training
Procedure: Brain Computer Interface
Experimental: gBCI-robot
generalized BCI-robot hand training
Procedure: Brain Computer Interface
Sham Comparator: sham-BCI
Sham BCI
Procedure: Brain Computer Interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FMA-UE
Time Frame: 3-month followup
3-month followup

Secondary Outcome Measures

Outcome Measure
Time Frame
ARAT
Time Frame: 3-month followup
3-month followup
MAS
Time Frame: 3-month followup
3-month followup

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 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 (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUHK 525513

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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