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

NCT07466277 | Recruiting

• 1 other identifier: 2025-1128
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder (SAD)

Keywords

Social Anxiety Disorder; Transcranial Magnetic Stimulation; Intermittent Theta-Burst Stimulation; Prefrontal Cortex

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score

  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).

  Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.

Secondary Outcomes (4)

• Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score

  Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.

• Change from Baseline in Hamilton Depression Rating Scale (HAMD) Total Score

  Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.

• Change from Baseline in Resting-State and Task-State Electroencephalogram (EEG) Metrics

  Baseline and immediately post-intervention (Week 1).

Study Arms (3)

Left PFC-iTBS

EXPERIMENTAL

Participants will receive active intermittent theta-burst stimulation (iTBS) targeting the left prefrontal cortex.

Device: Active Intermittent Theta-Burst Stimulation (iTBS)

Right PFC-iTBS

EXPERIMENTAL

Participants will receive active intermittent theta-burst stimulation (iTBS) targeting the right prefrontal cortex.

Device: Active Intermittent Theta-Burst Stimulation (iTBS)

Sham iTBS

SHAM COMPARATOR

Participants will receive sham intermittent theta-burst stimulation (iTBS) targeting the prefrontal cortex.

Device: Sham Intermittent Theta-Burst Stimulation (iTBS)

Interventions

Active Intermittent Theta-Burst Stimulation (iTBS) DEVICE

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.

Left PFC-iTBS; Right PFC-iTBS

Sham Intermittent Theta-Burst Stimulation (iTBS) DEVICE

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).

Sham iTBS

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310013, China

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Lei Lei Zheng, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Yang, PhD

CONTACT

+8613314590507; yang_han_life@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomly assigned to one of three parallel arms in a 1:1:1 ratio: active left PFC-iTBS, active right PFC-iTBS, or sham iTBS. Each participant will receive the designated intervention for 1 week (20 sessions total) and remain in their originally assigned arm throughout the intervention and the subsequent 8-week follow-up period.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 12, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 9 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a formal data access agreement, ensuring compliance with local data protection regulations regarding sensitive psychiatric data.

Locations

CN (1)