Short bursts of noninvasive brain stimulation to the prefrontal cortex for social anxiety
Intermittent Theta-Burst Stimulation Targeting the Prefrontal Cortex for Social Anxiety Disorder: A Randomized, Parallel-Group Comparative Study
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT07466277
This treatment will test whether daily intermittent theta-burst brain stimulation to the prefrontal cortex can reduce social anxiety symptoms in people with SAD while tracking brain changes with EEG.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07466277 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, sham-controlled trial comparing left-sided iTBS, right-sided iTBS, and sham stimulation in people with social anxiety disorder. Participants complete baseline questionnaires and a pre-treatment EEG, then receive an intensive one-week course of 20 sessions (four sessions per day for five days). Post-treatment EEG and questionnaires are collected immediately after the intervention, with follow-up visits at weeks 2, 4, 6, and 8 to monitor symptom change. The trial enrolls right-handed participants aged 16–70 with DSM-5 SAD and uses EEG to explore neurophysiological markers of response.
Who should consider this trial
Good fit: Right-handed individuals aged 16 to 70 who meet DSM-5 criteria for social anxiety disorder and have had stable psychiatric medication doses for at least four weeks are ideal candidates.
Not a fit: People with a history of seizures, major neurological disease, primary psychotic or bipolar disorders, unstable psychiatric medication, or who are not right-handed or outside the 16–70 age range are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the approach could reduce social anxiety symptoms more quickly and with good tolerability compared with some current options.
How similar studies have performed: iTBS and related TMS protocols have established efficacy in depression and show preliminary promise in anxiety disorders, but high-quality randomized evidence specifically for SAD is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Lei Lei Zheng, MD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Han Yang, PhD
- Email: yang_han_life@163.com
- Phone: +8613314590507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Social Anxiety Disorder, Transcranial Magnetic Stimulation, Intermittent Theta-Burst Stimulation, Prefrontal Cortex