Short bursts of noninvasive brain stimulation to the prefrontal cortex for social anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled trial comparing left-sided iTBS, right-sided iTBS, and sham stimulation in people with social anxiety disorder. Participants complete baseline questionnaires and a pre-treatment EEG, then receive an intensive one-week course of 20 sessions (four sessions per day for five days). Post-treatment EEG and questionnaires are collected immediately after the intervention, with follow-up visits at weeks 2, 4, 6, and 8 to monitor symptom change. The trial enrolls right-handed participants aged 16–70 with DSM-5 SAD and uses EEG to explore neurophysiological markers of response.

Why it matters

Who can join: the full rules

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 related disorders, or somatic symptom and related disorders-are also ineligible. Furthermore, the study excludes those with metallic implants in the head or neck, any other clear contraindications to Transcranial Magnetic Stimulation (TMS), or a previous history of receiving TMS treatment, which is restricted to prevent potential unblinding. Finally, current use, or use within the past 4 weeks, of adequate doses of benzodiazepines for more than 2 weeks is an exclusion criterion, as it may limit the therapeutic efficacy of TMS.

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Lei Lei Zheng, MD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Han Yang, PhD
• Email: yang_han_life@163.com
• Phone: +8613314590507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.