Neurofeedback-guided TMS to improve upper‑limb control after stroke
Development and Validation of an Adaptive Neurofeedback Interface Using Transcranial Magnetic Stimulation to Modulate Cortical Excitability
This project will test whether timing noninvasive brain stimulation (TMS) using fNIRS neurofeedback can improve arm and hand control in adults who had a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT07088107 on ClinicalTrials.gov |
What this trial studies
The team is developing a closed-loop system that uses functional near-infrared spectroscopy (fNIRS) signals to trigger transcranial magnetic stimulation (TMS) at precise moments. They will first test the accuracy of the fNIRS-triggered TMS interface in healthy adults and then run a proof-of-concept study in postacute ischemic subcortical stroke patients. The patient phase will measure changes in hemiplegic upper-extremity motor control and cortical excitability of the ipsilesional motor cortex. Results will determine whether fNIRS-controlled TMS is a feasible and clinically useful form of post-stroke neuromodulation.
Who should consider this trial
Good fit: Adults aged 18–80 with ischemic subcortical stroke at least 6 months earlier, residual upper-limb function at FTHUE levels 2–7, able to consent and communicate in Chinese are ideal candidates.
Not a fit: Patients with cognitive impairment (MoCA <21/22), major uncontrolled chronic illnesses, contraindications to TMS, or those very early after stroke are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve recovery of arm and hand function after stroke by delivering TMS at brain-state–specific times, potentially increasing treatment effectiveness.
How similar studies have performed: Conventional TMS has shown mixed benefits in post-stroke rehabilitation, and closed-loop fNIRS-triggered TMS is a novel approach with limited prior clinical outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants who meet the following criteria will be included: 1. Diagnosed with ischemic subcortical stroke, with stroke onset≥6 months. 2. Age between 18 and 80 years. 3. Residual upper limb functions between levels 2-7 in the FTHUE. 4. Capable of providing informed written consent. 5. Capable of reading and communicating with Chinese. Exclusion Criteria: Patients who meet any of the following criteria will be excluded: 1. any contraindications to TMS (screened by the safety checklist by Rossi). 2. signs of cognitive impairment, with a Montreal cognitive assessment score\<21/22 out of 30. 3. any moderate-to-severe chronic illness, such as uncontrolled hypertension, heart disease or renal failure. Healthy participants should be aged between 18 and 80, with no known history of neurological diseases. They should not have any moderate-to-severe chronic illness, such as uncontrolled hypertension, heart disease or renal failure.
Where this trial is running
Hong Kong and 1 other locations
- Hong Kong Polytechnic University — Hong Kong, Hong Kong (Not_yet_recruiting)
- Hong Kong Polytechnic University - Brain Stimulation Laboratory — 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.