Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07254390

Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-05-12

48

Participants Needed

1

Research Sites

116 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable
  • Age �3E�3D 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 �3C�3D 2)
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

ICS Maugeri - Montescano

Montescano, Pavia, Italy, 27040

Actively Recruiting

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Research Team

C

Cira Fundaro'

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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