Using TMS to treat anxiety and trauma-related disorders

Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders: a Pilot Study

This study is testing a new type of brain stimulation to see if it can help people with anxiety disorders feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06475040 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness and safety of accelerated intermittent theta burst stimulation (aiTBS) applied to a novel transcranial magnetic stimulation (TMS) target in patients with anxiety disorders. The study focuses on the right dorsomedial prefrontal cortex (dmPFC), which has been identified as a promising target for reducing anxiety symptoms. Participants will undergo 50 sessions of aiTBS over five consecutive days, with clinical assessments and MRI scans conducted before and after treatment to measure outcomes. This approach seeks to address the high rates of non-response to current anxiety treatments by utilizing a more targeted TMS method.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 60 with a diagnosis of generalized anxiety disorder, social anxiety disorder, panic disorder, or post-traumatic stress disorder who are treatment-resistant.

Not a fit: Patients with substance use disorders, significant suicidal ideation, or other severe mental health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from anxiety disorders who have not responded to traditional therapies.

How similar studies have performed: While this specific approach is novel, previous studies have shown promise in using TMS for anxiety treatment, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), and/or post-traumatic stress disorder (PTSD) as defined by DSM-5 criteria.
2. Male or female between 18 and 60 years old.
3. Right-handed.
4. Can understand and sign an informed consent document.
5. Beck Anxiety Inventory (BAI) score of 16 or higher.
6. On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
7. In good general health, as ascertained by medical history.
8. Pharmacological treatment resistance or psychotherapeutic treatment resistance.

Exclusion Criteria:

1. Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders.
2. History of brain surgery and epilepsy.
3. Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
4. Any medical condition or medication that increases the risk of seizures.
5. Pregnancy.
6. Intellectual disability.
7. Current severe somatic disease, such as cancer, heart failure, pneumonia, etc.
8. Severe claustrophobia that prevents the use of MRI.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Huiru Cui, Ph.D — Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Huiru Cui, Ph.D

Conditions Anxiety Symptoms; Anxiety Disorders