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Recruiting NCT07254390

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active trans-auricular vagus nerve stimulation (tVNS), Sham tVNS, Khymeia robotic upper limb rehabilitation, Traditional Rehabilitation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Active trans-auricular vagus nerve stimulation (tVNS)
    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.
  • Device Sham tVNS
    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).
  • Device Khymeia robotic upper limb rehabilitation
    Robotic-assisted rehabilitation for the upper limbs using the Khymeia system.
  • Behavioral Traditional Rehabilitation
    Standard traditional physical therapy and rehabilitation protocols for upper limb recovery.

Primary outcome measures

  • Upper limb motor recovery assessed by Fugl-Meyer Assessment (FMA-UE) [Time frame: Baseline and 4 weeks after treatment]
Secondary outcome measures (7)
  • Functional Independence Measure (FIM) [Time frame: Baseline and 4 weeks.]
  • Barthel Index [Time frame: Baseline and 4 weeks]
  • Mini-Mental State Examination (MMSE) [Time frame: Baseline and 4 weeks]
  • Frontal Assessment Battery (FAB) [Time frame: Baseline and 4 weeks]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline and 4 weeks]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline and 4 weeks]
  • Somatosensory Evoked Potentials (Median Nerve) [Time frame: Baseline and 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • ICS Maugeri - Montescano — Montescano

Identifiers

NCT: NCT07254390 · 2665

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗