Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
Recruitment status was Recruiting
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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 |
- Clinician-Administered PTSD Scale (CAPS)
- 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 |
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 |
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| Contact: Bradley V Watts, MD | 802-295-9363 ext 5688 | bradley.v.watts@dartmouth.edu |
| 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 | |
| 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:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013