taVNS real stimulation for Parkinson's (NCT06665113)
Ear stimulation slows Parkinson progression
- Trial ID
- NCT06665113
- Official Title
- A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients
- Goal
- Ear stimulation slows Parkinson progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Kezhong Zhang
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinson Disease, Idiopathic
- Interventions
- taVNS real stimulation, taVNS sham stimulation
Summary For Families
Goal: to see whether long-term, non-invasive stimulation of the vagus nerve through the outer ear can protect the brain and slow progression in people with early Parkinson's disease. Approach: participants are randomly assigned, and neither they nor the researchers know who gets real versus sham stimulation, with a device delivering mild electrical pulses to a part of the ear linked to the vagus nerve over a long period. Eligibility: adults 55 to 75 with a diagnosis of idiopathic Parkinson's within the last 3 years, mild disease (stage 2.5 or less at medication start), and already taking standard Parkinson's medications. Note: people with significant memory problems, prior vagus nerve stimulation, certain heart or ear conditions, recent use of specific neuroprotective or dopamine-affecting drugs, or other major medical issues are excluded.
Locations
- The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying taVNS real stimulation. Goal: to see whether long-term, non-invasive stimulation of the vagus nerve through the outer ear can protect the brain and slow progression in people with early Parkinson's disease. Approach: participants are randomly assigned, and neither they nor the researchers know who gets real versus sham stimulation, with a device delivering mild electrical pulses to a part of the ear linked to the vagus nerve over a long period. Eligibility: adults 55 to 75 with a diagnosis of idiopathic Parkinson's within the last 3 years, mild disease (stage 2.5 or less at medication start), and already taking standard Parkinson's medications. Note: people with significant memory problems, prior vagus nerve stimulation, certain heart or ear conditions, recent use of specific neuroprotective or dopamine-affecting drugs, or other major medical issues are excluded.
- Who can participate?
- Participants must be between 55 Years and 75 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 5 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 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 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?
- Each patient will receive one 30-minute stimulation session per day (at least 5 days per week) for 270 consecutive days.