Ear vagus nerve stimulation plus TENS to improve arm movement after stroke
Effect of Combining Transcutaneous Vagus Nerve Stimulation With Peripheral Nerve Stimulation on Upper Limb Motor Function in People With Stroke: A Single- Blinded Randomised Controlled Trial
This study will test whether combining gentle ear vagus nerve stimulation with TENS and task-focused practice can help improve upper‑limb movement in people more than six months after a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Kowloon) |
| Trial ID | NCT07425756 on ClinicalTrials.gov |
What this trial studies
This is a blinded, randomized controlled trial that pairs transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous electrical nerve stimulation (TENS) with task‑oriented training for upper limb recovery after stroke. Participants are randomized to active or sham versions of the peripheral and auricular stimulations while performing repetitive, goal‑directed arm tasks. Eligible participants are 55–75 years old, at least six months post‑stroke, and have some preserved shoulder and wrist movement. Outcomes will focus on changes in motor function of the paretic upper limb over the intervention period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55–75 who are at least six months post‑stroke, can communicate, and have minimal antigravity shoulder movement and at least 5° wrist extension.
Not a fit: Patients with other neurological diseases, unstable medical conditions, implanted brain metal, a history of seizures, or those with little to no voluntary wrist/shoulder movement are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could modestly improve arm strength and function and make daily tasks easier for people living with chronic stroke.
How similar studies have performed: Prior invasive and noninvasive vagus nerve stimulation studies paired with rehabilitation have shown promise for improving post‑stroke motor recovery, and transcutaneous approaches are newer but supported by early positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 55 - 75 years old; 2. diagnosed with stroke confirmed by magnetic resonance imaging or computed tomography for more than 6 months; 3. had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder; 4. had at least 5 degrees of wrist extension in the antigravity position; 5. be able to communicate Exclusion Criteria: 1. had neurological disease other than stroke, e.g., Parkinson's disease or dementia; 2. ongoing healthy condition, e.g., angina pectoris, pain, or arthritis; 3. had any contraindications of taVNS (metal implants in the brain, history of seizure)
Where this trial is running
Kowloon
- The Hong Kong Polytechnic University — Kowloon, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Shamay Ng, Professor — The Hong Kong Polytechnic University
- Study coordinator: Shamay NG, PhD
- Email: shamay.ng@polyu.edu.hk
- Phone: +852 27664889
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.