Back to resultsBrain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brain Computer Interface
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility 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.
Sites / Locations
- Division of Biomedical Engineering, Dept Electronic EngineeringRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
fBCI-robot
gBCI-robot
sham-BCI
Arm Description
focalized BCI-robot hand training
generalized BCI-robot hand training
Sham BCI
Outcomes
Primary Outcome Measures
FMA-UE
Secondary Outcome Measures
ARAT
MAS
Full Information
NCT ID
NCT02323074
First Posted
December 18, 2014
Last Updated
July 4, 2016
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02323074
Brief Title
Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke
Official Title
Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fBCI-robot
Arm Type
Experimental
Arm Description
focalized BCI-robot hand training
Arm Title
gBCI-robot
Arm Type
Experimental
Arm Description
generalized BCI-robot hand training
Arm Title
sham-BCI
Arm Type
Sham Comparator
Arm Description
Sham BCI
Intervention Type
Procedure
Intervention Name(s)
Brain Computer Interface
Primary Outcome Measure Information:
Title
FMA-UE
Time Frame
3-month followup
Secondary Outcome Measure Information:
Title
ARAT
Time Frame
3-month followup
Title
MAS
Time Frame
3-month followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Division of Biomedical Engineering, Dept Electronic Engineering
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
12. IPD Sharing Statement
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Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke
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