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

Overview

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.