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Trial record 19 of 260 for:    Open Studies | "Stress Disorders, Post-Traumatic"

Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by White River Junction VAMC.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT00134446
First received: August 23, 2005
Last updated: October 28, 2005
Last verified: March 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00134446     History of Changes
Other Study ID Numbers: WRJVAMC16744, Hitchcock Foundation
Study First Received: August 23, 2005
Last Updated: October 28, 2005
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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014