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

NCT ID: NCT02323074

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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fBCI-robot

focalized BCI-robot hand training

Group Type EXPERIMENTAL

Brain Computer Interface

Intervention Type PROCEDURE

gBCI-robot

generalized BCI-robot hand training

Group Type EXPERIMENTAL

Brain Computer Interface

Intervention Type PROCEDURE

sham-BCI

Sham BCI

Group Type SHAM_COMPARATOR

Brain Computer Interface

Intervention Type PROCEDURE

Interventions

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Brain Computer Interface

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Biomedical Engineering, Dept Electronic Engineering

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Raymond Tong, PhD

Role: primary

+852 3943 8454

Other Identifiers

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CUHK 525513

Identifier Type: -

Identifier Source: org_study_id

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