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

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Stroke

Treatments: Device: Traditional Rehabilitation + Sham tVNS; Device: Traditional Rehabilitation + Active tVNS; Device: Sham trans-auricular vagus nerve stimulation + Khymeia training; Device: Active trans-auricular vagus nerve stimulation (tVNS) + Khymeia training

Study type: Interventional

Funder types: Other

Identifiers

NCT07254390

2665

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups

Khymeia + Active tVNS

Experimental group

Treatment:

Device: Active trans-auricular vagus nerve stimulation (tVNS) + Khymeia training

Khymeia + Sham tVNS

Sham Comparator group

Treatment:

Device: Sham trans-auricular vagus nerve stimulation + Khymeia training

Traditional Rehabilitation + Active tVNS

Experimental group

Treatment:

Device: Traditional Rehabilitation + Active tVNS

Traditional Rehabilitation + Sham tVNS

Sham Comparator group

Treatment:

Device: Traditional Rehabilitation + Sham tVNS