Brain Computer Interface(BCI) System for Stroke Rehabilitation
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ClinicalTrials.gov Identifier: NCT02323061 |
Recruitment Status :
Completed
First Posted : December 23, 2014
Last Update Posted : September 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Procedure: BCI using EEG signals | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Brain Computer Interface(BCI) System for Stroke Rehabilitation |
Actual Study Start Date : | May 1, 2015 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: BCI-robot (I)
EEG guided training based on ipsilesional EEG signals; Training for 20 sessions
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Procedure: 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. |
Experimental: BCI-robot (IC)
EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions
|
Procedure: 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. |
Placebo Comparator: robot
Training for 20 sessions
|
Procedure: 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. |
- FMA-UE [ Time Frame: 6-month followup ]
- ARAT [ Time Frame: 6-month followup ]
- MAS [ Time Frame: 6-month followup ]
- MRI [ Time Frame: 6-month followup ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323061
Hong Kong | |
Department of Biomedical Engineering, The Chinese University of Hong Kong | |
Hong Kong, Hong Kong |
Responsible Party: | Raymond KY Tong, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT02323061 |
Other Study ID Numbers: |
4055037 |
First Posted: | December 23, 2014 Key Record Dates |
Last Update Posted: | September 18, 2017 |
Last Verified: | September 2017 |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |