Vagus nerve stimulation plus robot-guided arm therapy to improve arm movement, breathing muscle strength, and quality of life after stroke
Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life in Stroke Patients
The researchers will try adding gentle ear-based vagus nerve stimulation to robot-guided arm therapy to see if it improves arm movement, breathing muscle strength, and quality of life in adults aged 18–70 who had a stroke more than six months ago and have moderate-to-severe arm weakness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07259577 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 30 adults (18–70 years) at least six months after ischemic or hemorrhagic stroke with moderate-to-severe upper-extremity weakness to compare robot-assisted upper limb training paired with transcutaneous auricular vagus nerve stimulation (taVNS) versus the same robot training with sham stimulation. Participants must have sufficient cognition (MMSE ≥23) and low to moderate spasticity (Modified Ashworth ≤2) and will be excluded if they have implanted stimulators, significant cardiac arrhythmias, severe spasticity, dysphagia, aphasia, recent botulinum toxin to the arm, or major psychiatric conditions. Outcome measures include upper extremity motor function (Fugl-Meyer UE), respiratory muscle strength, and quality-of-life metrics collected before and after the intervention. The trial is conducted at Istanbul Üniversitesi-Cerrahpaşa Büyükçekmece campus and compares active taVNS delivered at the ear versus sham stimulation paired with the same robotic training protocol.
Who should consider this trial
Good fit: Ideal candidates are adults 18–70 years old, at least six months post-stroke (ischemic or hemorrhagic), with moderate-to-severe upper-extremity weakness (Fugl-Meyer UE score 20–50), MMSE ≥23, and upper-extremity spasticity ≤2 on the Modified Ashworth Scale.
Not a fit: People with implanted electrical stimulators (e.g., pacemakers), significant cardiac arrhythmias, severe spasticity (Modified Ashworth ≥3), dysphagia or aphasia, recent botulinum toxin to the affected arm, or major cognitive/psychiatric conditions are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, combining taVNS with robot-assisted arm therapy could improve arm movement, strengthen breathing muscles, and increase daily independence and quality of life for people with chronic moderate-to-severe stroke.
How similar studies have performed: Implanted vagus nerve stimulation paired with rehabilitation has shown functional gains in prior trials, while noninvasive taVNS is promising but less well established and few randomized studies have tested it combined with robot-assisted training.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18-70 years diagnosed with ischemic or hemorrhagic stroke lasting longer than 6 months, * Moderate to severe upper extremity weakness (20-50 out of 66 on the Fugl-Meyer Upper Extremity Motor Assessment Scale), * Ability to communicate and understand (Mini Mental State Examination (MMSE) score ≥ 23), * Upper extremity spasticity of 2 or less on the Modified Ashworth Scale. Exclusion Criteria: * Use of any stimulation device, such as a pacemaker or other neurostimulator, * Presence of a medical or cognitive condition (personality disorder, anxiety, depression, etc.) that would prevent participants from participating in the study, * Receiving a Botox injection into the affected upper extremity at least 4 weeks prior, * Severe spasticity in the upper extremity (Modified Ashworth Scale ≥3), * Presence of dysphagia or aphasia, * Presence of cardiac problems such as atrial fibrillation, atrial flutter, sick sinus syndrome, or atrioventricular block.
Where this trial is running
Istanbul, Istanbul
- İstanbul Üniversitesi-Cerrahpaşa Sağlık Bilimleri Fakültesi Büyükçekmece Yerleşkesi — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Yusuf Açıkgöz — Istanbul University - Cerrahpasa
- Study coordinator: Yusuf Açıkgöz
- Email: fztysfackgz@gmail.com
- Phone: +905396335531
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.