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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Sham Transcutaneous auricular vagus nerve stimulation; Device: Active Transcutaneous auricular vagus nerve stimulation

• Registration Number: NCT05950347
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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 anxiety. The investigators hypothesize that taVNS will improve anxiety and cortical activity in Parkinson's disease patients with anxiety.

Detailed Description

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 anxiety 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 Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-18
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28
• Study Start: 2023-08-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• (1) diagnosed with idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD;
• (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for anxiety and Hamilton Anxiety Scale (HAMA) score ≥ 12;
• (3) stable pharmacotherapy for PD at least one month prior to the study;
• (4) 40-80 years old;
• (5) willing to sign written informed consent.

Exclusion Criteria

• (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) < 23;
• (2) took antianxiety drugs;
• (3) with taVNS contraindications;
• (4) received VNS treatment during the past month;
• (5) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Transcutaneous auricular vagus nerve stimulation	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.
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.

Primary Outcome Measures

Name	Time	Method
change of Hamilton Anxiety Scale Score	Assessed at baseline, one day post intervention，2 weeks post intervention	Hamilton Anxiety Scale (HAM-A score), which was used for assessing the degree of anxiety. It consists of 14 symptomatic definition elements, with a total possible score of 56. The differences in HAMA score before and after treatment can be used to evaluate the effect of taVNS treatment.

Secondary Outcome Measures

Name	Time	Method
change of HbO2 in the prefrontal cortex	Assessed at baseline, one day post intervention	The change of HbO2 in the prefrontal cortex is accessed by fNIRS combined with verbal fluency task. Recent documents have highlighted the effectiveness of fNIRS combined with verbal fluency task (VFT) in detecting alterations in the PFC in patients with anxiety. The differences in HbO2 before and after treatment can be used to evaluate the effect of taVNS treatment.
change of Unified Parkinson's Disease Rating Scale Score section III	Assessed at baseline, one day post intervention，2 weeks post intervention	Unified Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms.
change of Unified Parkinson's Disease Rating Scale Score section I	Assessed at baseline, one day post intervention，2 weeks post intervention	Unified Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions)

Trial Locations

Locations (1)

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