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

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

Tracking Information

• First Submitted Date: December 18, 2014
• First Posted Date: December 23, 2014
• Last Update Posted Date: July 6, 2016
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2014): FMA-UE [ Time Frame: 3-month followup ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 18, 2014)

• ARAT [ Time Frame: 3-month followup ]
• MAS [ Time Frame: 3-month followup ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stroke
• Intervention: Procedure: Brain Computer Interface

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 18, 2014): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT02323074
• Other Study ID Numbers: CUHK 525513
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Raymond KY Tong, Chinese University of Hong Kong
• Original Responsible Party: Same as current
• Current Study Sponsor: Chinese University of Hong Kong
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chinese University of Hong Kong
• Verification Date: July 2016