Vagus nerve stimulation plus robot-guided arm therapy to improve arm movement, breathing muscle strength, and quality of life 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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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.