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

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What is being tested

medication-combined transcutaneous vagus nerve stimulation

+ medication-combined sham stimulation

Device
Who is being recruted

Generalized Anxiety Disorder

+ Anxiety Disorders

+ Mental Disorders

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorXijing Hospital
Study ContactYihuan Yihuan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 5, 2023

Actual date on which the first participant was enrolled.

The study is designed to explore how effective a treatment combining medication and a technique called transcutaneous vagus nerve stimulation (tVNS) is for people with generalized anxiety disorder. This disorder causes excessive and uncontrollable worry about various aspects of life. The research aims to see not only if this combination helps reduce anxiety symptoms but also to understand how tVNS works in this context. By better understanding these mechanisms, the study hopes to improve treatment options for those struggling with anxiety, offering them more effective ways to manage their condition. Participants in the study are randomly divided into two groups. One group receives the actual tVNS treatment along with their medication, while the other group receives a sham or fake version of the stimulation, also with medication. This approach helps researchers determine the true effectiveness of the real treatment compared to a placebo effect. Over a period of four weeks, participants undergo assessments to measure changes in their anxiety symptoms. Brain function and other laboratory tests are conducted before starting the treatment and after completing it, providing insights into the biological impact of the treatment. The process is carefully monitored to ensure safety and accuracy.

Official TitleEfficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder
NCT06134323
Principal SponsorXijing Hospital
Study ContactYihuan Yihuan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Generalized Anxiety DisorderAnxiety DisordersMental Disorders

Criteria

3 inclusion criteria required to participate
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.

6 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive anti-anxiety medication and transcutaneous vagus nerve stimulation

Group II

Placebo
Participants will receive anti-anxiety medication and sham stimulation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, ChinaOpen The First Affiliated Hospital of Air Force Military Medical University in Google Maps
Recruiting

Xi'an No.3 Hospital

Xi'an, China
Suspended2 Study Centers