Combining ear (auricular) vagus nerve stimulation with robotic arm training to improve arm function after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.