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Brain Computer Interface（BCI） System for Stroke Rehabilitation

NCT ID: NCT02323061

Last Updated: 2017-09-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-06-30

Brief Summary

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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.

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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BCI-robot (I)

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

Group Type EXPERIMENTAL

BCI using EEG signals

Intervention Type PROCEDURE

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.

BCI-robot (IC)

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

Group Type EXPERIMENTAL

BCI using EEG signals

Intervention Type PROCEDURE

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.

robot

Training for 20 sessions

Group Type PLACEBO_COMPARATOR

BCI using EEG signals

Intervention Type PROCEDURE

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.

Interventions

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BCI using EEG signals

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.

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;
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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 33551777 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32997632 (View on PubMed)

Other Identifiers

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4055037

Identifier Type: -

Identifier Source: org_study_id