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

N/ANot Yet RecruitingNCT07679529

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Active Transcutaneous auricular vagus nerve stimulationDEVICE

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 stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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

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

Central Contacts

Kezhong Zhang

CONTACT

13770840575 kezhong_zhang1969@126.com

Data from ClinicalTrials.gov

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