The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Depression in PD

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07679529
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Active Transcutaneous auricular vagus nerve stimulation — DEVICE
    Active Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.Sham Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. The stimulation paradigm was identical to that of the real stimulation group. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
  • Sham Transcutaneous auricular vagus nerve stimulation — DEVICE
    Two modified dot-like electrodes delivered the stimulation to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min. Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.

Study Details

This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with depression. The investigators hypothesize that taVNS will improve depression and cortical activity in Parkinson's disease patients with depression.

Key Dates

First listed
Jul 1, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: real Transcutaneous auricular vagus nerve stimulation
    Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
  • Sham Comparator: Sham Transcutaneous auricular vagus nerve stimulation
    Two modified dot-like electrodes delivered the stimulation to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min. Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.

Primary Outcome Measure

change of Hamilton Depression Scale Score [ Time Frame: Assessed at baseline, one day post intervention,2 weeks post intervention ]

Central Contacts

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