Gentle ear stimulation improves movement

Trial ID
NCT06409338
Official Title
Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
Goal
Gentle ear stimulation improves movement
Phase
NA
Status
RECRUITING
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study Type
INTERVENTIONAL
Enrollment
32 participants
Conditions
Parkinson Disease
Interventions
Transcutaneous auricular vagus nerve stimulation (active), Transcutaneous auricular vagus nerve stimulation (sham)

Plain-Language Summary

The goal is to see whether gentle electrical stimulation of the vagus nerve at the outer ear can change brain circuits and reduce Parkinson's motor symptoms in people with early-stage disease. The approach, called transcutaneous auricular vagus nerve stimulation or taVNS, delivers mild pulses to the auricular branch of the vagus nerve to modulate brain network activity involved in movement, and the study compares active stimulation to a sham while participants remain on their usual PD medications. Because taVNS is a non-drug device, it is being tested as an add-on that may affect symptom control independently of levodopa or other PD drugs. Eligible participants are 40 to 80 years old with idiopathic PD at Hoehn and Yahr stage 2 or less on medication, on stable PD meds for at least a month, and without significant cognitive impairment, severe tremor or dyskinesia, recent VNS, anticholinergic use, taVNS contraindications, or serious other medical conditions.

Locations

  • the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Frequently Asked Questions

What is this trial testing?
This trial is studying Transcutaneous auricular vagus nerve stimulation (active). The goal is to see whether gentle electrical stimulation of the vagus nerve at the outer ear can change brain circuits and reduce Parkinson's motor symptoms in people with early-stage disease. The approach, called transcutaneous auricular vagus nerve stimulation or taVNS, delivers mild pulses to the auricular branch of the vagus nerve to modulate brain network activity involved in movement, and the study compares active stimulation to a sham while participants remain on their usual PD medications. Because taVNS is a non-drug device, it is being tested as an add-on that may affect symptom control independently of levodopa or other PD drugs. Eligible participants are 40 to 80 years old with idiopathic PD at Hoehn and Yahr stage 2 or less on medication, on stable PD meds for at least a month, and without significant cognitive impairment, severe tremor or dyskinesia, recent VNS, anticholinergic use, taVNS contraindications, or serious other medical conditions.
Who can participate?
Participants must be between 40 Years and 80 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 3 months.

View on ClinicalTrials.gov