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Recruiting NCT07466277

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

Trial Parameters

Condition Social Anxiety Disorder (SAD)
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 16 Years
Max Age 70 Years
Start Date 2025-12-09
Completion 2026-12-01
Interventions
Active Intermittent Theta-Burst Stimulation (iTBS)Sham Intermittent Theta-Burst Stimulation (iTBS)

Brief Summary

This study aims to investigate the therapeutic effects of intermittent theta burst stimulation on social anxiety disorder and to track physiological changes in the brain using electroencephalography (EEG). Eligible SAD participants, after voluntarily signing an informed consent form, will first complete basic information collection, baseline questionnaire completion, and a pre-treatment EEG data collection session lasting approximately 30 minutes (including resting-state and task-state recordings). Subsequently, participants will be randomly assigned to one of three groups (left iTBS group, right iTBS group, or sham stimulation group) to receive intensive treatment for one week (4 sessions daily for 5 consecutive days, totaling 20 sessions). Immediately following the intervention, the research team will conduct post-treatment EEG data collection and gather questionnaire assessments. Participants will also undergo follow-up visits at weeks 2, 4, 6, and 8 post-treatment to complete questionnaires and report any adverse events. All study procedures are strictly and safely conducted by trained professionals. Participation is entirely voluntary, and participants may withdraw unconditionally at any time during the study.

Eligibility Criteria

Inclusion Criteria: Eligible participants must be right-handed individuals aged 16 to 70 years who meet the diagnostic criteria for Social Anxiety Disorder (SAD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). If participants are taking concurrent psychiatric medications, their dosage must have been stable for at least 4 weeks prior to enrollment. Additionally, all individuals must voluntarily agree to participate in the study and provide written informed consent. Exclusion Criteria: Individuals will be excluded if they have a history of neurological disorders or other severe somatic diseases, including but not limited to seizures, central nervous system tumors, stroke, or brain aneurysms. Participants meeting DSM-5 diagnostic criteria for other primary psychiatric disorders-such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, other anxiety disorders, obsessive-compulsive and re

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