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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323074
• Other study ID #: CUHK 525513
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2014
• Last updated: July 4, 2016
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: The University of Hong Kong/Hospital Authority Hong Kong West Cluster: Hong Kong
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Brain Computer Interface

Locations

Country	Name	City	State
Hong Kong	Division of Biomedical Engineering, Dept Electronic Engineering	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMA-UE		3-month followup	No
Secondary	ARAT		3-month followup	No
Secondary	MAS		3-month followup	No