Transcutaneous Auricular Vagus Ner… for Parkinson's (AVANTGARDE-PD, NCT07337226)
Ear stimulation improves walking speed
- Trial ID
- NCT07337226
- Official Title
- Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)
- Study Acronym
- AVANTGARDE-PD
- Goal
- Ear stimulation improves walking speed
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Idiopathic Parkinson's Disease (PD)
- Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS), Conventional Physical Therapy (cPT), Sensorized Treadmill Training (STT)
Summary For Families
The study is testing whether non-invasive ear stimulation that targets the vagus nerve can improve walking and brain function in people recently diagnosed with Parkinson's, and whether it is safe and produces measurable biological effects when added to physical therapy. Participants get either active or placebo ear stimulation while doing treadmill and conventional physical therapy across 12 sessions over 4 weeks, and researchers will measure walking speed and gait, brain scans of activity and blood flow, and blood and saliva markers of inflammation and neurodegeneration. This stimulation activates the ear branch of the vagus nerve and engages brainstem pathways involved in movement, alertness, and inflammation; previous work has shown it can affect brain rhythms, gait, thinking, and inflammatory markers. The trial is looking for people aged 50 to 80 who were diagnosed within the last 6 months, can walk at least 10 meters alone, have a mental status test score above 24, have been on stable therapy for at least a month, and are not on high levodopa-equivalent doses or have ear or magnetic resonance imaging contraindications.
Locations
- Campus Biomedico, Roma, RM, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcutaneous Auricular Vagus Nerve Stimulation (taVNS). The study is testing whether non-invasive ear stimulation that targets the vagus nerve can improve walking and brain function in people recently diagnosed with Parkinson's, and whether it is safe and produces measurable biological effects when added to physical therapy. Participants get either active or placebo ear stimulation while doing treadmill and conventional physical therapy across 12 sessions over 4 weeks, and researchers will measure walking speed and gait, brain scans of activity and blood flow, and blood and saliva markers of inflammation and neurodegeneration. This stimulation activates the ear branch of the vagus nerve and engages brainstem pathways involved in movement, alertness, and inflammation; previous work has shown it can affect brain rhythms, gait, thinking, and inflammatory markers. The trial is looking for people aged 50 to 80 who were diagnosed within the last 6 months, can walk at least 10 meters alone, have a mental status test score above 24, have been on stable therapy for at least a month, and are not on high levodopa-equivalent doses or have ear or magnetic resonance imaging contraindications.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 8 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 4 groups, and 2 are sham (a pretend version of the procedure) groups. Because assignment is random, you have about a 2 in 4 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will attend 12 rehabilitation sessions over 4 weeks (three per week).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.