Ear nerve stimulation during rehabilitation for people recovering from a recent stroke
Tests gentle ear nerve stimulation alongside rehabilitation in adults recovering from stroke.
Key facts
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Where
- Montescano, ItalySee the site
- Trial code
- Registry title
- Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
- Status
- Recruiting
- People taking part
- 48 people, planned
- Started
- 8 Jan 2025
- Expected to end
- 3 Apr 2027
- Type of study
- Interventional, 4 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Active trans-auricular vagus nerve stimulation (tVNS)
- Sham tVNS
- Khymeia robotic upper limb rehabilitation
- Traditional Rehabilitation
- Record updated
- 12 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke in the last 6 months and have weakness on one side, including the arm. It tests ear nerve stimulation during rehabilitation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stroke (blocked or bleeding) within the previous 6 months, clinically stable, with one brain lesion matching the movement problem and arm weakness. Muscle stiffness must be mild or moderate (Modified Ashworth Scale ≤ 2).
Main reasons for not taking part
- More than one brain lesion on scans
- Severe muscle stiffness (Modified Ashworth Scale 3-4)
- Aphasia that prevents understanding spoken instructions
- Cognitive decline or behaviour problems that disturb cooperation in training
- Bone or joint problems or surgery results that prevent rehabilitation training
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- ICS Maugeri - MontescanoMontescano, ItalyContact: Cira Fundarò, MDTaking people
About the trial
What the trial wants to find out
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
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.
The 4 groups in the trial
- Khymeia + Sham tVNSSham treatment, for comparison
Treatment: Sham tVNS and Khymeia robotic upper limb rehabilitation
- Traditional Rehabilitation + Active tVNSTreatment being tested
Treatment: Active trans-auricular vagus nerve stimulation (tVNS) and Traditional Rehabilitation
- Traditional Rehabilitation + Sham tVNSSham treatment, for comparison
Treatment: Sham tVNS and Traditional Rehabilitation
- Khymeia + Active tVNSTreatment being tested
Treatment: Active trans-auricular vagus nerve stimulation (tVNS) and Khymeia robotic upper limb rehabilitation
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Ear nerve stimulation during rehabilitation for people recovering from a recent strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 May 2026