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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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).

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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score — Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.
  The LSAS is used to assess the severity of social anxiety symptoms by evaluating fear and avoidance across multiple social and performance situations. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety symptoms (worse outcome).

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China