NCT07254390Recruiting
Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 8 Jan 2025
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Stroke
- NCT number
- NCT07254390
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 8 Jan 2025 to the primary completion date, 20 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive decline or behavioral disorders interfering with collaboration during training
- Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training
Other
- Multiple brain lesions on neuroimaging
- Severe spasticity (Modified Ashworth Scale 3-4)
- Aphasia preventing comprehension of verbal instructions
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICS Maugeri - Montescano Coordinator of this site? Confirm its status | Montescano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.