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Ear nerve stimulation with treadmill training for walking in early Parkinson's disease

Tests ear vagus nerve stimulation plus physical therapy for walking in Parkinson's disease.

Key facts

Who runs it
Fondazione Policlinico Universitario Campus Bio-Medico
Where
Roma, ItalySee the site
Trial code
Registry title
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
Status
Recruiting
People taking part
60 people, planned
Started
14 Feb 2026
Expected to end
Oct 2027
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)
  • Conventional Physical Therapy (cPT)
  • Sensorized Treadmill Training (STT)
Record updated
16 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 80 who were diagnosed with idiopathic Parkinson's disease within the last 6 months and can walk on their own.

Age
50 to 80 years
Sex
All sexes can join.
Disease stage
Idiopathic Parkinson's disease diagnosed within 6 months, confirmed by a neurologist who specialises in Parkinson's disease and movement disorders.
Earlier treatment
Must be on stable therapy for at least 1 month before the study. Must not be in other neurorehabilitation programs within 3 months.

Main reasons for not taking part

  • Signs of atypical or vascular parkinsonism, or another diagnosis (for example normal pressure hydrocephalus)
  • Levodopa equivalent daily dose above 300 mg
  • Any reason that rules out ear nerve stimulation (for example ear lesions, hearing prosthesis)
  • Any reason that rules out MRI (for example non-compatible pacemaker or prosthesis, claustrophobia)
  • Other neurological, orthopedic or active medical or cancer condition that would affect taking part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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
  • On stable therapy for at least 1 month prior to the experiment

Who cannot take part

  • Concomitant neurological, orthopedic or active medical/oncological condition that would affect participating to the study
  • 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)
  • Attempting to other neurorehabilitation programs within 3 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 80 years old?

Where in Italy

  • Campus BiomedicoRoma, ItalyContact: Massimo Marano, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 4 groups in the trial

  • taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT)Existing treatment, for comparison

    Participants will receive active taVNS, stimulation parameters: 25 Hz frequency, 200 μs pulse width, and intensity adjusted to the individual's sensory threshold, delivered to the left auricular tragus for the duration of each session (\~30 minutes). During stimulation, participants will perform treadmill walking on a sensorized treadmill system with simultaneous conventional physical therapy exercises focused on posture, balance, and gait re-education. Sessions will be delivered over a 4-week period, for a total of 10 sessions.

    Treatment: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physical Therapy (cPT), and Sensorized Treadmill Training (STT)

  • taVNS paired with conventional physical therapy (cPT)Existing treatment, for comparison

    Participants will receive active taVNS (same parameters and device as Arm 1) during conventional physical therapy sessions without treadmill training. Sessions will be delivered over a 4-week period, for a total of 10 sessions.

    Treatment: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Conventional Physical Therapy (cPT)

  • Sham taVNS paired with STT and cPTSham treatment, for comparison

    Sham stimulation will consist of few impulses delivered at 25 Hz for a duration of 60'' before waning, creating the same initial sensation without continuous current delivering. Participants will simultaneously undergo treadmill-based and conventional physical therapy as described above. Schedule: 10 sessions will be delivered over a 4-week period.

    Treatment: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Conventional Physical Therapy (cPT), and Sensorized Treadmill Training (STT)

  • Sham taVNS paired with cPTSham treatment, for comparison

    Participants will receive sham stimulation (same device and sham procedure as Arm 3) during conventional physical therapy sessions without treadmill training. Schedule: 10 sessions will be delivered over a 4-week period.

    Treatment: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS) and Conventional Physical Therapy (cPT)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)
Plain-language title
Ear nerve stimulation with treadmill training for walking in early Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07337226, who can take part
Record updated
16 July 2026