Randomized Study of Intermittent Theta-Burst Stimulation on the Prefrontal Cortex to Treat Social Anxiety Disorder

What this Trial Is About

This research aims to evaluate the effects of intermittent theta burst stimulation iTBS, a non-invasive brain stimulation technique, on social anxiety disorder SAD. The study focuses on patients aged 16 to 70 years who meet the DSM-5 diagnostic criteria for SAD and seeks to understand the clinical benefits and physiological brain changes measured by electroencephalography EEG. It is designed as a randomized, double-blind, sham-controlled trial to provide high-quality evidence on iTBS efficacy and underlying brain mechanisms. Participants will be randomly assigned to one of three groups active iTBS targeting the left prefrontal cortex, active iTBS targeting the right prefrontal cortex, or sham stimulation. The treatment consists of 20 intensive sessions delivered over one week, with 4 sessions daily for 5 consecutive days. Both active and sham treatments use a figure-8 coil, with active stimulation at 120% of the resting motor threshold. Sham stimulation mimics the sensation and sounds of active treatment but does not produce therapeutic brain effects. Throughout the study, participants will complete baseline and post-treatment EEG recordings and questionnaires measuring social anxiety and related symptoms. Follow-up visits occur at weeks 2, 4, 6, and 8 after treatment to assess long-term effects and monitor any adverse events. The primary outcome is the change in Liebowitz Social Anxiety Scale LSAS scores, with additional clinical and EEG measures tracked. All procedures are conducted by trained professionals, and participation is voluntary with the option to withdraw at any time.

Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Social Anxiety Disorder