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
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorders||Device: transcranial magnetic stimulation||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder|
|Study Start Date :||March 2004|
- Clinician-Administered PTSD Scale (CAPS)
- PTSD Clinician Checklist (PCL)
- Beck Depression Inventory (BDI)
- State-Trait Anxiety Inventory (STAI)
- Side Effect Checklist
- Brief Cognitive Examination
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
|Contact: Bradley V Watts, MD||802-295-9363 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Bradley V Watts, MD|
|Principal Investigator:||Bradley V Watts, MD||White River Junction Veterans Affairs Medical Center|