ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

This study is currently recruiting participants.
Verified by White River Junction VAMC, March 2005

Sponsored by: White River Junction VAMC
Information provided by: White River Junction VAMC
ClinicalTrials.gov Identifier: NCT00134446
  Purpose

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 Intervention Phase
Post-Traumatic Stress Disorders
Device: transcranial magnetic stimulation
Phase IV

MedlinePlus related topics:   Anxiety    Post-Traumatic Stress Disorder    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder

Further study details as provided by White River Junction VAMC:

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

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

Estimated Enrollment:   40
Study Start Date:   March 2004

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 VAMC

Investigators
Principal Investigator:     Bradley V Watts, MD     White River Junction VAMC    
  More Information


Study ID Numbers:   WRJVAMC16744, Hitchcock Foundation
First Received:   August 23, 2005
Last Updated:   October 28, 2005
ClinicalTrials.gov Identifier:   NCT00134446
Health Authority:   United States: Federal Government

Keywords provided by White River Junction VAMC:
post traumatic stress disorder  
PTSD  
trauma  
transcranial magnetic stimulation  
randomized clinical trial  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers