Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)for Social Anxiety Disorder: A Randomized Controlled Clinical Trial.

This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions:

• Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD?
• What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?

Social Anxiety Disorder (SAD) is a common psychiatric condition characterized by excessive fear of social situations, leading to significant functional impairment and reduced quality of life. Conventional treatments, including pharmacotherapy and cognitive behavioral therapy, have limitations in terms of response rate and adverse effects. Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel, non-invasive neuromodulation approach targeting the auricular branch of the vagus nerve, which has shown potential anxiolytic effects in clinical studies.

This clinical trial is designed to evaluate the efficacy and safety of taVNS in patients with SAD. The trial adopts a randomized, doubled-blind, sham-controlled design. Participants will be allocated to receive either active taVNS or sham stimulation using identical devices. Active taVNS will deliver bilateral electrical stimulation at the concha cymba and concha cavum with a current intensity up to the individual's maximum tolerable level (≤5 mA), whereas sham stimulation will use a weak current intensity of 0.1 mA.

The primary objectives of this pilot study are to determine whether taVNS demonstrates preliminary clinical efficacy in improving social anxiety symptoms and to assess the incidence of adverse events during treatment. The findings will provide critical data to guide future large-scale randomized controlled trials evaluating the therapeutic potential of taVNS in SAD.

Inclusion Criteria:

Fulfillment of the DSM-5 diagnostic criteria for Social Anxiety Disorder (SAD). A Liebowitz Social Anxiety Scale (LSAS) score of ≥30 and a Clinical Global Impression-Severity (CGI-S) score of ≥4.

Age between 18 and 70 years. Voluntary provision of written informed consent. If on psychotropic medications, maintenance of a stable dose for at least six weeks prior to enrollment.

Exclusion Criteria:

A lifetime history of bipolar disorder, schizophrenia, or obsessive-compulsive disorder.

Any cognitive impairments that could interfere with the study. Significant suicidal ideation or behavior within the past six months. Patients with rapidly deteriorating conditions. Previous taVNS treatment within the past month. Contraindications to auricular vagus nerve stimulation, such as ear infections, inflammation, skin lesions, or hypersensitivity of the ear.

Presence of a pacemaker or other implanted medical devices, or severe neurological, renal, cardiovascular, or hepatic diseases.

Concurrent engagement in any form of psychotherapy. History of substance or alcohol abuse. Inability to comply with psychological assessments. Incapable of providing informed consent. Pregnant or lactating. Other reasons as deemed unsuitable for inclusion by the research team.