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NCT Number: NCT07679529

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

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.

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Key information

About this study

Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of depression symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention. The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

This study recruited right-handed subjects from the Department of Neurology, Huai'an Second People's Hospital. The inclusion criteria for patients with PD and depression were as follows: diagnosis of idiopathic Parkinson's disease based on the clinical diagnostic criteria of the Movement Disorder Society; diagnosis of depressive disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Hamilton Depression Rating Scale (HAMD) score ≥ 8; stable medication regimens for Parkinson's disease for at least one month prior to enrollment; aged 40 to 80 years; and voluntary participation with written informed consent. In addition, age- and gender-matched non-depressed PD patients and healthy controls were enrolled to further compare brain functional characteristics among different groups.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. change of Hamilton Depression Scale Score

    Time frame: Assessed at baseline, one day post intervention,2 weeks post intervention

    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

  2. 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

    Time frame: Assessed at baseline, one day post intervention#2 weeks post intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Kezhong Zhang

CONTACT

[email protected]

13770840575

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • The Second People's Hospital of Huai'an

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation Alleviates Depressive Symptoms in Patients With Parkinson's Disease and Depression During Verbal Fluency Tasks

Acronym: PD-D-taVNS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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