Using brain-computer interface neurofeedback to improve stroke rehabilitation
Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke: A Randomized Controlled Trial
This study is testing whether a special brain-computer interface can help stroke patients improve their arm movement better than a standard training method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT06503484 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of closed-loop brain-computer interface (BCI) driven observational imitation training against sham BCI open-loop training in enhancing upper limb motor functions in stroke patients. The study will involve 44 participants who will engage in kinesthetic motor imagery, with the closed-loop group receiving real-time feedback based on their brain activity, while the sham group will receive feedback based on another participant's activity. The trial will measure improvements in motor function and mirror neuron activation using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG). Participants will undergo ten training sessions to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a chronic ischemic subcortical stroke and mild to moderate upper limb impairment.
Not a fit: Patients with severe spasticity, cognitive impairments, or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for stroke patients by improving their upper limb motor functions.
How similar studies have performed: Previous studies have shown promise in using BCI for rehabilitation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. unilateral upper extremity motor deficits caused by ischemic stroke, confirmed by medical documents such as discharge summary and/or neuroimaging examinations. 2. chronic phase of stroke, i.e., time after stroke onset more than six months. 3. aged between 18 and 75 years old. 4. with mildly-to-moderately impaired upper limb functional activity that is stratified according to the levels 3-7 in the Functional Test for the Hemiplegic Upper Extremity. 5. able to give informed written consent to participate in the study. 6. able to read and understand traditional Chinese. Exclusion Criteria 1. previous diagnosis of any neurological disease excluding ischemic stroke. 2. presence of any sign of cognitive problems (The Montreal cognitive assessment Hong Kong version\<22/30). 3. Severe spasticity measured by the Modified Ashworth Scale score\>2 in the hand, wrist or elbow extensor muscle in the hemiparetic upper extremity. 4. with other notable impairments of the upper limb not caused by stroke (e.g., bone fracture in the past year, congenital deformity, or other impairments). 5. current participation in any other treatment programme or clinical study involving exercise, non-invasive brain stimulation, or BCI/neurofeedback.
Where this trial is running
Hong Kong, Hong Kong
- Jack Jiaqi Zhang — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Jack Jiaqi Zhang, PhD
- Email: jack-jiaqi.zhang@polyu.edu.hk
- Phone: 27666696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.