Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo … (NCT07337226) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
60 participantsStarted 2026-01
Plain-language summary
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
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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);
* Concomitant neurological, orthopedic or active medical/oncological condition that would affect participating to the study;
* Attempting to other neurorehabilitation programs within 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of objective changes in gait speed (m/s) through gait analysis.
Timeframe: Baseline (T0) and Post-intervention (T1, 4 weeks)