TMS for Anxiety and Trauma-related Disorders

NCT06475040 | Completed Results

• 1 other identifier: HRCui
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The present pilot study will apply accelerated intermittent theta burst stimulation (aiTBS) to a novel transcranial magnetic stimulation (TMS) target for anxiety derived via causal network mapping.

Conditions

Anxiety Symptoms; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Beck Anxiety Inventory (BAI)

  The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety symptom severity. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.

  Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.

Secondary Outcomes (3)

• BAI Response

  Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.

• Hamilton Anxiety Rating Scale (HAMA)

  Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.

• Sheehan Disability Scale (SDS)

  Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.

Study Arms (1)

Open-label aiTBS to novel right dmPFC TMS anxiety target

EXPERIMENTAL

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)

Open-label aiTBS to novel right dmPFC TMS anxiety target

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Male or female between 18 and 60 years old.
• Right-handed.
• Can understand and sign an informed consent document.
• Beck Anxiety Inventory (BAI) score of 16 or higher.
• On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
• In good general health, as ascertained by medical history.
• Pharmacological treatment resistance or psychotherapeutic treatment resistance.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Huiru Cui
• Organization: Shanghai Mental Health Center

cuihuiru@163.com

02134773230

Study Officials

• Huiru Cui, Ph.D

  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 19, 2024
• Primary Completion: April 13, 2025
• Study Completion: April 13, 2025
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)