Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
Recruiting · NCT07337226 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Campus Biomedico - Roma, RM, Italy