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 find out whether long-term, noninvasive stimulation of the ear branch of the vagus nerve can slow neurodegeneration and protect motor function in early Parkinson's. Approach: the study uses transcutaneous auricular vagus nerve stimulation, a small device that delivers mild electrical pulses to the ear to modulate vagal signaling and related brain circuits, which may reduce neuroinflammation and support dopamine neuron survival; it is randomized and double-blinded with real versus sham stimulation, given alongside each person’s usual Parkinson’s medications without changing levodopa dosing. Eligibility: people 55 to 75 years old with idiopathic Parkinson’s for three years or less and H&Y stage 2.5 or lower at medication start, on standard anti-PD meds, while excluding those with significant cognitive impairment, recent use of certain neuroprotective drugs, prior vagus stimulation, pacemakers or DBS, major heart or MRI contraindications, or a history of falls or freezing.
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 find out whether long-term, noninvasive stimulation of the ear branch of the vagus nerve can slow neurodegeneration and protect motor function in early Parkinson's. Approach: the study uses transcutaneous auricular vagus nerve stimulation, a small device that delivers mild electrical pulses to the ear to modulate vagal signaling and related brain circuits, which may reduce neuroinflammation and support dopamine neuron survival; it is randomized and double-blinded with real versus sham stimulation, given alongside each person’s usual Parkinson’s medications without changing levodopa dosing. Eligibility: people 55 to 75 years old with idiopathic Parkinson’s for three years or less and H&Y stage 2.5 or lower at medication start, on standard anti-PD meds, while excluding those with significant cognitive impairment, recent use of certain neuroprotective drugs, prior vagus stimulation, pacemakers or DBS, major heart or MRI contraindications, or a history of falls or freezing.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 5 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.