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

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ClinicalTrials.gov Identifier: NCT02323074
Recruitment Status : Unknown
Verified July 2016 by Raymond KY Tong, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : December 23, 2014
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: Brain Computer Interface Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. FMA-UE [ Time Frame: 3-month followup ]

Secondary Outcome Measures :
  1. ARAT [ Time Frame: 3-month followup ]
  2. MAS [ Time Frame: 3-month followup ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02323074


Locations
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Hong Kong
Division of Biomedical Engineering, Dept Electronic Engineering Recruiting
Hong Kong, Hong Kong
Contact: Raymond Tong, PhD    +852 3943 8454      
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: NCT02323074    
Other Study ID Numbers: CUHK 525513
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases