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New treatment option for Idiopathic Parkinson's Disease (PD)
Official title Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease
ClinicalTrials.gov ID: NCT07337226
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- 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.
You likely can't join if
- 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 people);
- Concomitant neurological, orthopedic or active medical/oncological condition that would affect participating to the study;
- Attempting to other neurorehabilitation programs within 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.