Brain Computer Interface（BCI） System for Stroke Rehabilitation

• ClinicalTrials.gov Identifier: NCT02323061
• Recruitment Status: Completed
• First Posted: December 23, 2014
• Last Update Posted: September 18, 2017
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Raymond KY Tong, Chinese University of Hong Kong

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Procedure: BCI using EEG signals	Not Applicable

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: BCI-robot (I); EEG guided training based on ipsilesional 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.
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.

Outcome Measures

Primary Outcome Measures :

1. FMA-UE [ Time Frame: 6-month followup ]
2. ARAT [ Time Frame: 6-month followup ]

Secondary Outcome Measures :

1. MAS [ Time Frame: 6-month followup ]
2. MRI [ Time Frame: 6-month followup ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Hong Kong

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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
• Last Update Posted: September 18, 2017
• Last Verified: September 2017

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases