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Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00134446
Recruitment Status : Unknown
Verified March 2005 by White River Junction Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : August 24, 2005
Last Update Posted : October 31, 2005
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorders Device: transcranial magnetic stimulation Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder
Study Start Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS)

Secondary Outcome Measures :
  1. PTSD Clinician Checklist (PCL)
  2. Beck Depression Inventory (BDI)
  3. State-Trait Anxiety Inventory (STAI)
  4. Side Effect Checklist
  5. Brief Cognitive Examination

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134446


Contacts
Contact: Bradley V Watts, MD 802-295-9363 ext 5688 bradley.v.watts@dartmouth.edu

Locations
United States, Vermont
White River Junction VAMC Recruiting
White River Junction, Vermont, United States, 05001
Contact: Bradley V Watts, MD    802-295-9363 ext 5688    bradley.v.watts@dartmouth.edu   
Principal Investigator: Bradley V Watts, MD         
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
Investigators
Principal Investigator: Bradley V Watts, MD White River Junction Veterans Affairs Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00134446     History of Changes
Other Study ID Numbers: WRJVAMC16744
Hitchcock Foundation
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: October 31, 2005
Last Verified: March 2005

Keywords provided by White River Junction Veterans Affairs Medical Center:
post traumatic stress disorder
PTSD
trauma
transcranial magnetic stimulation
randomized clinical trial

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders