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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 55-75 years.
• Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
• Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation.
• Parkinson's disease duration ≤ 3 years.
• Receiving standard anti-Parkinson's disease medication treatment.
Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Kezhong Zhang, Professor
kezhong_zhang1969@126.com
400-13770840575
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2026-06
Participants
Target number of participants: 12
Treatments
Experimental: Standard anti-Parkinson's disease medication treatment + taVNS real stimulation
For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba.~Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.
Sham_comparator: Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation
For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.
Related Therapeutic Areas
Sponsors
Leads: Kezhong Zhang