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Clinical Trials/NCT00134446
NCT00134446
Unknown
Phase 4

A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder

White River Junction Veterans Affairs Medical Center1 site in 1 country40 target enrollmentMarch 2004

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorders
Sponsor
White River Junction Veterans Affairs Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Clinician-Administered PTSD Scale (CAPS)
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinician-Administered PTSD Scale (CAPS)

Secondary Outcomes

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

Study Sites (1)

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