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Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-01-08
Completion Date
2027-04-03
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
Active trans-auricular vagus nerve stimulation (tVNS) + Khymeia training
Active trans-auricular vagus nerve stimulation (tVNS) with the Parasym® device (CE 0197). Electrode placed on the left tragus, 25 Hz, 250 µs, intensity to tolerance, 60 min/day, 5 days/week for 4 weeks, combined with Khymeia robotic upper limb rehabilitation.
Sham trans-auricular vagus nerve stimulation + Khymeia training
Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS, combined with Khymeia rehabilitation.
Traditional Rehabilitation + Active tVNS
Active tVNS with Parasym® (left tragus, 25 Hz, 250 µs, 60 min/day, 5 days/week for 4 weeks) combined with traditional rehabilitation.
Traditional Rehabilitation + Sham tVNS
Sham tVNS with Parasym® device, electrodes on left earlobe, 60 minutes/day, 5 days/week for 4 week. Same duration and schedule, combined with traditional rehabilitation.
Locations (1)
ICS Maugeri - Montescano
Montescano, Pavia, Italy