Combining ear (auricular) vagus nerve stimulation with robotic arm training to improve arm function after stroke
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
We will test whether adding painless ear vagus nerve stimulation to robotic arm training helps adults with moderate to severe arm weakness after a stroke improve movement, strength, and daily use of the affected arm.
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 | NCT07257107 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares robotic-assisted upper extremity training combined with transcutaneous auricular vagus nerve stimulation (taVNS) versus robotic training with sham stimulation in people with chronic stroke. Eligible participants are adults 18–70 years with ischemic or hemorrhagic stroke more than six months earlier, moderate-to-severe upper limb weakness (Fugl-Meyer UE 20–50) and sufficient cognition (MMSE ≥23). Outcomes include motor impairment and function (Fugl-Meyer), grip strength, activities of daily living, and quality of life measured before and after the intervention. The study is conducted at Istanbul University - Cerrahpaşa and excludes people with implanted stimulators, significant cardiac arrhythmias, severe spasticity, recent Botox to the arm, dysphagia, or aphasia.
Who should consider this trial
Good fit: Adults 18–70 with ischemic or hemorrhagic stroke at least six months prior, moderate-to-severe upper limb weakness (Fugl-Meyer UE 20–50), MMSE ≥23, and low spasticity (Modified Ashworth Scale ≤2) are ideal candidates.
Not a fit: Patients with implanted stimulators (eg, pacemakers), significant cardiac arrhythmias, severe spasticity (MAS ≥3), recent Botox to the affected arm, dysphagia, or aphasia are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the combined taVNS plus robotic training approach could produce greater improvements in arm movement, strength, and daily function than robotic training alone.
How similar studies have performed: Robotic-assisted training has shown benefit for upper limb recovery after stroke in prior studies, while noninvasive taVNS results have been limited and mixed, so combining the two is a relatively novel approach with limited prior clinical proof.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) 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), and 4) 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: Rüstem Mustafaoğlu, associate professor — Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
- Study coordinator: Rüstem MUSTAFAOĞLU, associate professor
- Email: rustem.mustafaoglu@iuc.edu.tr
- Phone: +905554178535
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.