NCT07254390

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-01-08
• Primary completion: 2026-12-20
• Completion: 2027-04-03
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Italy