Trans-auricular vagus nerve stimulation plus robotic or traditional arm rehab for recovery after subacute stroke
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 pilot tests whether gentle ear (trans-auricular) vagus-nerve stimulation added to robotic or usual arm therapy helps people recovering from a recent stroke regain upper-limb movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Montescano, Pavia) |
| Trial ID | NCT07254390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a single cortical or subcortical ischemic or hemorrhagic stroke within the previous six months causing hemiplegia, with some preserved ability to follow instructions, a submaximal Motricity Index, and spasticity no greater than Modified Ashworth Scale 2 are ideal candidates.
Not a fit: Patients with multiple brain lesions, severe spasticity (MAS 3–4), aphasia or cognitive/behavioral problems that prevent participation, orthopedic limitations, or who cannot attend intensive daily rehab are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding noninvasive ear vagus stimulation could speed or strengthen recovery of arm movement when paired with standard rehabilitation.
How similar studies have performed: Implanted vagus nerve stimulation paired with training has shown encouraging results in prior trials, while noninvasive transcutaneous/auricular VNS remains less established but supported by small, preliminary studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montescano, Pavia
- ICS Maugeri - Montescano — Montescano, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Cira Fundaro'
- Email: cira.fundaro@icsmaugeri.it
- Phone: 0385247268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.