Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Social Anxiety Disorder
Recruiting · NCT07466277 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Eligible participants must be right-handed individuals aged 16 to 70 years who meet the diagnostic criteria for Social Anxiety Disorder (SAD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). If participants are taking concurrent psychiatric medications, their dosage must have been stable for at least 4 weeks prior to enrollment. Additionally, all individuals must voluntarily agree to participate in the study and provide written informed consent.
Exclusion criteria
- Individuals will be excluded if they have a history of neurological disorders or other severe somatic diseases, including but not limited to seizures, central nervous system tumors, stroke, or brain aneurysms. Participants meeting DSM-5 diagnostic criteria for other primary psychiatric disorders-such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, other anxiety disorders, obsessive-compulsive and related disorders, or somatic symptom and related disorders-are also ineligible. Furthermore, the study excludes those with metallic implants in the head or neck, any other clear contraindications to Transcranial Magnetic Stimulation (TMS), or a previous history of receiving TMS treatment, which is restricted to prevent potential unblinding. Finally, current use, or use within the past 4 weeks, of adequate doses of benzodiazepines for more than 2 weeks is an exclusion criterion, as it may limit the therapeutic efficacy of TMS.
Where it is running
1 location listed.
- Second Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China