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
Istituti Clinici Scientifici Maugeri SpA
48 participants
Jan 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria5
- 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
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Interventions
Active 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.
Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS (60 min/day, 5 days/week for 4 weeks).
Robotic-assisted rehabilitation for the upper limbs using the Khymeia system.
Standard traditional physical therapy and rehabilitation protocols for upper limb recovery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07254390