High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD

Study Overview
=================
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.

Official Title
-----------------
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder

Conditions
-----------------
PTSD, Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex
* Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Treatment as usual, wait list control group | |
| Active Comparator: rTMS at 10Hz<br>10 Hz rTMS of the right dorsolateral prefrontal cortex | Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex<br>* Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex<br>|
| Active Comparator: rTMS at 20Hz<br>20 Hz rTMS of the right dorsolateral prefrontal cortex | Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex<br>* Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale , CAPS | The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD. | day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist, PCL | The PCL consists of 17 items measured on a 5-point Likert scale ranging from not at all to extremely | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Post Traumatic Stress Disorder