Using transcutaneous vagus nerve stimulation to treat generalized anxiety disorder

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

This study is testing if combining a new type of nerve stimulation with medication can help people with generalized anxiety disorder feel less anxious.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 2 sites (Xi'an, Shaanxi and 1 other locations)
• Trial ID: NCT06134323 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining medication with transcutaneous vagus nerve stimulation (tVNS) in patients diagnosed with generalized anxiety disorder. Participants will be randomly assigned to either the tVNS group or a sham stimulation group for a duration of four weeks. Assessments will be conducted at baseline and weekly throughout the treatment period to evaluate anxiety levels and brain function. The study aims to explore both the efficacy of this combined treatment and the underlying mechanisms of tVNS in alleviating anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates include adults meeting DSM-5 criteria for generalized anxiety disorder who have not used certain psychiatric medications in the past month.

Not a fit: Patients with other major mental disorders or significant organic brain lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from generalized anxiety disorder.

How similar studies have performed: While the use of tVNS is a relatively novel approach, preliminary studies have shown promise in similar applications for anxiety treatment.

Eligibility criteria

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.

Where this trial is running

Xi'an, Shaanxi and 1 other locations

• The First Affiliated Hospital of Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
• Xi'an No.3 Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Yihuan Yihuan — The First Affiliated Hospital of the Air Force Medical University
• Study coordinator: Yihuan Yihuan

Conditions Generalized Anxiety Disorder