Ear nerve stimulation during rehabilitation for people recovering from a recent stroke
Tests gentle ear nerve stimulation alongside rehabilitation in adults recovering from stroke.
Plain-language title generated from the registry record
Registry title: Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
Key facts
- Where
- Montescano, ItalySee the site
Where in Italy
- ICS Maugeri - MontescanoMontescano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Trial code
- NCT07254390
- Record updated
- 12 May 2026
- Original description
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.Read full original descriptionShow less
Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery Post-Stroke in the Subacute Phase During Training With the Khymeia Technological Device and Traditional Rehabilitation
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 rehabilitation enhances cortical plasticity and accelerates motor recovery. Adverse effects are expected to be minimal, with previous studies reporting only mild transient skin irritation. The results may provide new insights into the neurophysiological mechanisms of recovery and support the integration of non-invasive neuromodulation in post-stroke rehabilitation.
Inclusion: 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: Cognitive decline or behavioral disorders interfering with collaboration during training; Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training; Multiple brain lesions on neuroimaging; Severe spasticity (Modified Ashworth Scale 3-4); Aphasia preventing comprehension of verbal instructions.