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

NCT07679529 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Active Transcutaneous auricular vagus nerve stimulation

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.

DEVICE

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.

Sponsors & Collaborators

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Kezhong Zhang · China, Jiang Su the First Affiliated Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-08-01
Completion
2026-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679529 on ClinicalTrials.gov