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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
ICS Maugeri - Montescano
RECRUITING
Montescano
Contact Information
Primary
Cira Fundaro'
cira.fundaro@icsmaugeri.it
0385247268
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2027-04-03
Participants
Target number of participants: 48
Treatments
Experimental: Khymeia + Active tVNS
Sham_comparator: Khymeia + Sham tVNS
Experimental: Traditional Rehabilitation + Active tVNS
Sham_comparator: Traditional Rehabilitation + Sham tVNS
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov