Trans-auricular vagus nerve stimulation plus robotic or traditional arm rehab for recovery after subacute 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 pilot allocates subacute stroke patients admitted for intensive rehabilitation to four groups combining either active or sham trans-auricular vagus nerve stimulation (tVNS) with either traditional or Khymeia robotic upper-limb training. tVNS is delivered with the Parasym® device to the left ear for 60 minutes daily during the rehabilitation period. The primary outcome is change in upper-limb motor function measured by the Fugl-Meyer scale, with secondary outcomes including other clinical, cognitive, psychological, neurophysiological, and autonomic measures. The trial targets adults within six months of a single ischemic or hemorrhagic stroke who can follow instructions and provide informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable
* Age ≥ 18 years
* Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit
* Cognitively able to understand and follow therapeutic instructions
* Upper limb weakness confirmed by a Motricity Index score below maximum
* Spasticity, if present, compatible with limb function (Modified Ashworth Scale ≤ 2)
* Written informed consent provided

Exclusion Criteria:

* Multiple brain lesions on neuroimaging
* Severe spasticity (Modified Ashworth Scale 3-4)
* Aphasia preventing comprehension of verbal instructions
* Cognitive decline or behavioral disorders interfering with collaboration during training
* Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training

Where it's running

• ICS Maugeri - Montescano
  Montescano, Pavia, Italy Recruiting

Study contacts

• Study coordinator: Cira Fundaro'
• Email: cira.fundaro@icsmaugeri.it
• Phone: 0385247268

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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.