PTSD, Post Traumatic Stress Disorder
Conditions
Keywords
PTSD, Post Traumatic Stress Disorder
Brief summary
The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
Detailed description
This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.
Interventions
OTHER10 Hz rTMS of the right dorsolateral prefrontal cortex
Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
OTHER20 Hz rTMS of the right dorsolateral prefrontal cortex
Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
Sponsors
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to give informed consent * Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID * CAPS score of at least 40 * Males or females between 18-65 years of age * Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.
Exclusion criteria
* Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder * Patients with HDRS score ≥ 18 * A metallic implant in cranium (except the mouth) * Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety * ECT treatment within the last three months * Patients with a history of epilepsy * Patients with neurological disorder leading to increased intracranial pressure * Participation in a new course of psychotherapy during the 24 days of the study * A new psychiatric medication within 6 weeks of enrolling in the study * Changes in psychiatric medication within 2 weeks of starting the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale , CAPS | day 10 | The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist, PCL | week 24 | The PCL consists of 17 items measured on a 5-point Likert scale ranging from not at all to extremely |
Countries
United States
Outcome results
None listed