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Brain Computer Interface（BCI） System for Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323061
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: BCI using EEG signals Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Computer Interface（BCI） System for Stroke Rehabilitation
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. FMA-UE [ Time Frame: 6-month followup ]
  2. ARAT [ Time Frame: 6-month followup ]

Secondary Outcome Measures :
  1. MAS [ Time Frame: 6-month followup ]
  2. MRI [ Time Frame: 6-month followup ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323061


Locations
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Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
More Information
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Responsible Party: Raymond KY Tong, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02323061    
Other Study ID Numbers: 4055037
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases