Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

December 13, 2023 updated by: Xijing Hospital

Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder

This is a randomized, double-blind, parallel-controlled study of patients with generalized anxiety disorder, who will be randomly assigned to either drug-combined transcutaneous vagus nerve stimulation (tVNS) group or drug-combined sham-stimulation group for a period of 4 weeks of treatment.Scale assessments will be performed at baseline, week 1, week 2, week 3, and week 4 of treatment, and brain function monitoring as well as laboratory tests will be performed at baseline and at the end of treatment, respectively.The aim of this study is to investigate the efficacy of medication combined with tVNS and the possible mechanisms of tVNS in the treatment of anxiety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Air Force Military Medical University
        • Contact:
          • Yihuan Chen
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xi'an No.3 Hospital
        • Contact:
          • Ruiguo Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meeting DSM-5 diagnostic criteria for Generalized Anxiety Disorder;
  • Having a first episode of Generalized Anxiety Disorder or not having used an anxiolytic, antidepressant, antipsychotic, or anticonvulsant medication in the last 1 month.
  • Having a Hamilton Anxiety Scale (HAMA) score of more than 14 and a Hamilton Depression Scale (HAMD-17) score of less than 17.

Exclusion Criteria:

  • Having organic brain lesions (e.g., cerebral hemorrhage, massive cerebral infarction, encephalitis, epilepsy); cardiac QTc interval > 450ms;
  • Current or previous diagnosis of other major diseases (e.g., coronary heart disease, pulmonary heart disease, etc.)
  • Currently or previously diagnosed with a mental disorder other than anxiety disorder (except for insomnia disorder);
  • Those who are participating or have participated in vagus nerve stimulation therapy; those who are participating in transcranial magnetic stimulation or transcranial direct current therapy;
  • Pregnant, breastfeeding, or planning to become pregnant during the trial;
  • Refusing to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: medication-combined transcutaneous vagus nerve stimulation
Participants will receive anti-anxiety medication and transcutaneous vagus nerve stimulation
Device: medication-combined transcutaneous vagus nerve stimulation
Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation
Placebo Comparator: medication-combined sham stimulation group
Participants will receive anti-anxiety medication and sham stimulation
Device: medication-combined sham stimulation
Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment
Time Frame: Baseline and Week 2 of the treatment
The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms. In this study, changes in scores at baseline and the second week of treatment will be used as the primary outcome measure.
Baseline and Week 2 of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of Treatment
Time Frame: Baseline and Week 4 of the treatment
The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms.Higher scores mean that the patient's anxiety is more severe.
Baseline and Week 4 of the treatment
Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment
Time Frame: Baseline and Week 2 of the treatment
The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.
Baseline and Week 2 of the treatment
Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment
Time Frame: Baseline and Week 4 of the treatment
The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.
Baseline and Week 4 of the treatment
Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment
Time Frame: Baseline and Week 2 of the treatment
The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.
Baseline and Week 2 of the treatment
Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment
Time Frame: Baseline and Week 4 of the treatment
The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.
Baseline and Week 4 of the treatment
Changes in brain function indicators from baseline to end of treatment
Time Frame: Baseline and Week 4 of the treatment
Functional near-infrared spectroscopy and event-related potentials will be used in this study to examine brain function in patients.Event-related potential (ERP) is a special brain evoked potential that is generated by intentionally giving a stimulus a special psychological meaning, using multiple or multiple stimuli. Functional near-infrared spectroscopy (fNIRS) can utilize the good scattering of 600-900nm near-infrared light by the main components of blood to obtain changes in oxyhemoglobin and deoxyhemoglobin during brain activity.
Baseline and Week 4 of the treatment
Incidence of adverse events in each group
Time Frame: Baseline and Week 4 of the treatment
During the study period, any treatment-related adverse events will be recorded and used to evaluate the safety of the intervention.Common side effects include changes in pronunciation, hoarseness, neck pain, cough, vomiting, etc
Baseline and Week 4 of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Yihuan Yihuan, The First Affiliated Hospital of the Air Force Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232271-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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