Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

October 28, 2005 updated by: White River Junction Veterans Affairs Medical Center

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Vermont
      • White River Junction, Vermont, United States, 05001
        • Recruiting
        • White River Junction VAMC
        • Contact:
        • Principal Investigator:
          • Bradley V Watts, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinician-Administered PTSD Scale (CAPS)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

White River Junction Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Bradley V Watts, MD, White River Junction Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

October 30, 2005

Last Update Submitted That Met QC Criteria

October 28, 2005

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRJVAMC16744
  • Hitchcock Foundation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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