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.
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
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