TMS for Anxiety and Trauma-related Disorders

NCT06475040 | Recruiting

• 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)

• Effectiveness as measured by Beck Anxiety Inventory

  Measure of severity of anxiety - total score of Beck Anxiety Inventory ranges from 0 to 63 (higher numbers indicate higher severity)

  Anxiety symptoms will be measured before the TMS treatment, immediately after 5 days of TMS, 1 week and 4 weeks respectively after completion of the TMS treatment

Secondary Outcomes (6)

• Safety as measured by number of participants with Adverse Events

  Each afternoon after treatment during the 5 days of treatment

• Resting-state functional MRI (rsfMRI) scan

  Baseline (before treatment) and after 5 days of TMS stimulation

• Hamilton Anxiety Rating Scale (HAMA)

  Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation

• State-Trait Anxiety Inventory (STAI)

  Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation

• Hamilton Depression Rating Scale (HAMD)

  Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation

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

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Huiru Cui, Ph.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiru Cui, Ph.D

CONTACT

86 21 34773230; cuihuiru@163.com

Jijun Wang, Ph.D

CONTACT

86 21 34773065; jijunwang27@163.com

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: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)