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

NCT07679529 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-06The First Affiliated Hospital
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Parkinson's disease; depression; taVNS

Outcome Measures

Primary Outcomes (2)

• change of Hamilton Depression Scale Score

  Hamilton Depression Scale (HAM-D score), which was used for assessing the degree of Depression.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment

  Assessed at baseline, one day post intervention,2 weeks post intervention

• change of Hamilton Depression Scale Score Hamilton Anxiety Scale (HAM-D score), which was used for assessing the degree of anxiety.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment

  Assessed at baseline, one day post intervention#2 weeks post intervention

Study Arms (2)

real Transcutaneous auricular vagus nerve stimulation

ACTIVE COMPARATOR

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.

Device: Active Transcutaneous auricular vagus nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

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.

Device: Sham Transcutaneous auricular vagus nerve stimulation

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.

real Transcutaneous auricular vagus nerve stimulation

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.

Sham Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• presence of cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \< 23; ongoing use of antidepressant medications; presence of contraindications related to transcutaneous auricular vagus nerve stimulation (taVNS); receipt of vagus nerve stimulation (VNS) treatment within the past month; and comorbid severe neurological, renal, cardiovascular or hepatic diseases.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Second People's Hospital of Huai'an: collaborator

MeSH Terms

Conditions

Parkinson Disease; Depression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Study Officials

• Kezhong Zhang

  China, Jiang Su the First Affiliated Hospital of Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Kezhong Zhang

CONTACT

13770840575; kezhong_zhang1969@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share