RecruitingNot ApplicableNCT07466277

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

Intermittent Theta-Burst Stimulation Targeting the Prefrontal Cortex for Social Anxiety Disorder: A Randomized, Parallel-Group Comparative Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of non-invasive brain stimulation called intermittent theta burst stimulation (iTBS) — a form of transcranial magnetic stimulation (TMS) — applied to the prefrontal cortex to reduce symptoms of social anxiety disorder. TMS uses magnetic pulses to briefly activate specific brain areas without surgery. **You may be eligible if...** - You are between 16 and 70 years old - You are right-handed - You have been diagnosed with social anxiety disorder (SAD) according to DSM-5 criteria - If you are on psychiatric medication, your dosage has been stable for at least 4 weeks - You voluntarily agree to participate and provide written consent **You may NOT be eligible if...** - You have a neurological condition such as epilepsy, brain tumor, stroke, or aneurysm - You have another serious psychiatric diagnosis beyond social anxiety - You have metal implants in your head that are incompatible with magnetic stimulation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive Intermittent Theta-Burst Stimulation (iTBS)

Active iTBS is delivered using a real "figure-8" coil targeting the prefrontal cortex. Stimulation is delivered at 120% of the resting motor threshold (RMT). The protocol consists of 3 sets of 50 Hz pulses repeated at 5 Hz (2s on, 8s off), totaling 1,800 pulses per session. The intensive treatment schedule includes 4 sessions per day for 5 consecutive days (1 week), totaling 20 sessions.

DEVICESham Intermittent Theta-Burst Stimulation (iTBS)

Sham iTBS is delivered using a visually identical sham "figure-8" coil. It produces similar acoustic clicks and scalp somatic sensations to mimic the active treatment, ensuring participant blinding. However, it uses same-direction currents causing opposing central currents, resulting in near-zero focal magnetic induction without therapeutic effect. The session schedule and apparent parameters strictly match the active group (4 sessions/day for 5 days).


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT07466277


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