🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training

RecruitingNAAges 18 Years - anyAllIstituti Clinici Scientifici Maugeri SpA
NCT07254390 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

This randomized pilot clinical study aims to investigate the effects of trans-auricular vagus nerve stimulation (tVNS) on neuromotor recovery in patients in the subacute phase after stroke. Participants admitted for intensive rehabilitation at ICS Maugeri Centers (Montescano, Pavia, Nervi) will be randomized into four groups receiving either traditional or technological rehabilitation (Khymeia device), combined with active or sham tVNS. The Parasym® device (CE 0197) delivers non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes daily. The primary outcome is the improvement in upper limb motor function, assessed by the Fugl-Meyer scale. Secondary outcomes include other clinical, cognitive, and psychological measures, as well as neurophysiological and cardiovascular autonomic parameters. The study hypothesizes that coupling tVNS with rehabili

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Active trans-auricular vagus nerve stimulation (tVNS)
  • Sham tVNS
  • Khymeia robotic upper limb rehabilitation
  • Traditional Rehabilitation
📍

Where

1 site
ICS Maugeri - Montescano
Montescano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy