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Brain Computer Interface（BCI） System for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
BCI using EEG signals
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
  2. Subcortical 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-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)).
  4. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.

Exclusion Criteria:

  1. Severe hand spasticity, open hand wound or hand deformity;
  2. Visual field deficits;
  3. Aphasia, neglect, and apraxia,
  4. Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
  5. History of alcohol, drug abuse or epilepsy,
  6. Bilateral infracts,
  7. Uncontrolled medical problems,
  8. Serious cognitive deficits,
  9. Other MRI contraindications

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BCI-robot (I)

BCI-robot (IC)

robot

Arm Description

EEG guided training based on ipsilesional EEG signals; Training for 20 sessions

EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions

Training for 20 sessions

Outcomes

Primary Outcome Measures

FMA-UE
ARAT

Secondary Outcome Measures

MAS
MRI

Full Information

First Posted
December 18, 2014
Last Updated
September 15, 2017
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02323061
Brief Title
Brain Computer Interface（BCI） System for Stroke Rehabilitation
Official Title
Brain Computer Interface（BCI） System for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

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
A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.

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
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCI-robot (I)
Arm Type
Experimental
Arm Description
EEG guided training based on ipsilesional EEG signals; Training for 20 sessions
Arm Title
BCI-robot (IC)
Arm Type
Experimental
Arm Description
EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions
Arm Title
robot
Arm Type
Placebo Comparator
Arm Description
Training for 20 sessions
Intervention Type
Procedure
Intervention Name(s)
BCI using EEG signals
Intervention Description
A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.
Primary Outcome Measure Information:
Title
FMA-UE
Time Frame
6-month followup
Title
ARAT
Time Frame
6-month followup
Secondary Outcome Measure Information:
Title
MAS
Time Frame
6-month followup
Title
MRI
Time Frame
6-month followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment; Subcortical ischemic lesion within the territory of the middle cerebral artery; Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)). Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection. Exclusion Criteria: Severe hand spasticity, open hand wound or hand deformity; Visual field deficits; Aphasia, neglect, and apraxia, Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up. History of alcohol, drug abuse or epilepsy, Bilateral infracts, Uncontrolled medical problems, Serious cognitive deficits, Other MRI contraindications
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
33551777
Citation
Lau CCY, Yuan K, Wong PCM, Chu WCW, Leung TW, Wong WW, Tong RKY. Modulation of Functional Connectivity and Low-Frequency Fluctuations After Brain-Computer Interface-Guided Robot Hand Training in Chronic Stroke: A 6-Month Follow-Up Study. Front Hum Neurosci. 2021 Jan 20;14:611064. doi: 10.3389/fnhum.2020.611064. eCollection 2020.
Results Reference
derived
PubMed Identifier
32997632
Citation
Yuan K, Wang X, Chen C, Lau CC, Chu WC, Tong RK. Interhemispheric Functional Reorganization and its Structural Base After BCI-Guided Upper-Limb Training in Chronic Stroke. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2525-2536. doi: 10.1109/TNSRE.2020.3027955. Epub 2020 Nov 6.
Results Reference
derived

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Brain Computer Interface（BCI） System for Stroke Rehabilitation

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