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
Plain-Language Summary
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.