Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

Phase 4

• Conditions: Post-Traumatic Stress Disorders

• Registration Number: NCT00134446
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Brief Summary

The purpose of this study is to determine if transcranial magnetic stimulation at 1 HZ to the right frontal cortex will decrease the symptoms of post-traumatic stress disorder (PTSD).

Detailed Description

Post-traumatic stress disorder (PTSD) is a psychiatric disorder that is common in the general population. PTSD symptoms include re-experiencing the traumatic event, avoidance of reminders of the trauma, and increased arousal. The primary treatments of PTSD are psychotherapy and antidepressant medications. While both are effective, many patients continue to have significant symptoms. Repetitive Transcranial Magnetic Stimulation (rTMS) is a new research and treatment modality that uses a small powerful electromagnet to directly stimulate the brain. This stimulation may increase or decrease brain activity. The treatments have been shown to be effective in other disorders such as depression. Initial treatment of patients with PTSD using rTMS has been hopeful. This study is the first randomized controlled trial to examine the efficacy of rTMS for PTSD.

This study would be the first randomized placebo controlled trial to examine the efficacy of Transcranial Magnetic Stimulation (rTMS) for PTSD. The primary hypothesis is that there will be significant improvement in the patients' PTSD symptoms from pre-treatment to post-treatment with rTMS. A secondary hypothesis is that the patients' co-morbid depressive symptoms will improve from pre-treatment to post-treatment. Forty subjects with PTSD will be recruited from the White River Junction VAMC. Patients will be randomly assigned to receive either active rTMS or sham rTMS. Patients, staff performing the treatments, and staff completing the assessments will all be blinded to active or sham treatment.

Study Timeline

• Study Start: 2004-03
• Status Verified: 2005-03
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Last Update Submitted: 2005-10-28
• Last Update Posted: 2005-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• PTSD diagnosis on standardized assessment
• Medically stable
• Eligible veteran of United States (US) military

Exclusion Criteria

• Active substance abuse
• History of seizures
• Metal in head or neck

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Name	Time	Method
Brief Cognitive Examination
PTSD Clinician Checklist (PCL)
Beck Depression Inventory (BDI)
State-Trait Anxiety Inventory (STAI)
Side Effect Checklist

Trial Locations

Locations (1)

White River Junction VAMC; 🇺🇸 White River Junction, Vermont, United States