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Clinical Trials/NCT02323061
NCT02323061
Completed
Not Applicable

Brain Computer Interface(BCI) System for Stroke Rehabilitation

Chinese University of Hong Kong1 site in 1 country25 target enrollmentMay 1, 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chinese University of Hong Kong
Enrollment
25
Locations
1
Primary Endpoint
ARAT
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2015
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raymond KY Tong

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

ARAT

Time Frame: 6-month followup

FMA-UE

Time Frame: 6-month followup

Secondary Outcomes

  • MRI(6-month followup)
  • MAS(6-month followup)

Study Sites (1)

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