NCT07337226Recruiting
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 14 Feb 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Diseases
- Parkinson disease
- NCT number
- NCT07337226
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 14 Feb 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant neurological, orthopedic or active medical/oncological condition that would affect participating to the study;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campus Biomedico Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.