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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Left PFC-iTBSExperimental treatment 1 intervention
Group B: Right PFC-iTBSExperimental treatment 1 intervention
Group C: Sham iTBSSham comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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

The HAMA assesses the severity of generalized anxiety symptoms, encompassing both psychological and somatic anxiety. The total score ranges from 0 to 56. Higher scores indicate more severe anxiety symptoms (worse outcome).

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

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

The HAMD is used to evaluate the severity of depressive symptoms. The 17-item version total score ranges from 0 to 52. Higher scores indicate more severe depressive symptoms (worse outcome).

Time frame
Baseline, immediately post-intervention (Week 1), and at Weeks 2, 4, 6, and 8 post-intervention.
3

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

The PSQI assesses subjective sleep quality and disturbances over the past month. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality, with scores greater than 5 indicative of severe sleep difficulties (worse outcome).

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

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

EEG will be used to measure neurophysiological brain activity. The specific metrics include changes in resting-state power (such as Alpha and Theta frequency bands) over the prefrontal cortex, as well as changes in the amplitudes of event-related potentials (ERPs) during cognitive tasks. These metrics serve as objective markers to evaluate the cortical activity changes induced by the iTBS intervention.

Time frame
Baseline and immediately post-intervention (Week 1).

Other outcomes

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