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

NCT07466277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Social Anxiety Disorder (SAD)

Interventions

DEVICE

Active 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.

DEVICE

Sham 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).

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Lei Lei Zheng, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466277 on ClinicalTrials.gov