Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) can improve gait and brain function in people with diagnosis of idiopathic Parkinson's disease (PD) within 6 months. It will also help researchers learn about the safety and biological effects of taVNS when used together with physical therapy.

The main questions it aims to answer are:

* Does taVNS paired with physical therapy improve walking speed and gait performance in people with PD? * Does taVNS change brain activity or breain perfusion related to movement? * Does taVNS reduce markers of inflammation and neurodegeneration in blood and saliva? Researchers will compare active taVNS to sham (placebo) stimulation to see if active taVNS works better when paired with physical therapy.

Participants will:

* Attend 12 rehabilitation sessions over 4 weeks (three per week) * Receive either active or sham taVNS during each session while doing treadmill and conventional physical therapy * Undergo gait and cognitive testing, MRI scans, and blood and saliva collection before and after treatment * Return for a follow-up visit four weeks after therapy to check how long the effects last

Eligibility criteria

Qualifiers

Idiopathic PD diagnosis within 6 months, confirmed by neurologist specialized in Parkinson's disease and movement disorders;

Ability to walking independently for at least 10 meters unassisted;

Age included between 50 and 80;

MMSE > 24;

Disqualifiers

Clinical and radiological red flags for atypical, vascular parkinsonism or alternative diagnosis (e.g., normal pressure hydrocephalus);

Levodopa equivalent daily dose > 300 mg;

Any contraindication for taVNS (e.g., ear lesions, auditory prosthesis)

Any contraindication for MRI (e.g., non compatible pacemakers or prosthesis, claustrophobic subjects);

Trial design

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)
  • Conventional Physical Therapy (cPT)
  • Sensorized Treadmill Training (STT)

Treatment groups

60 Participants
are divided into 4 treatment groups

Locations

This trial has no locations