Post-Traumatic Stress Disorders Clinical Trial
Official title:
A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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