Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD

Study Overview
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Brief Summary
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This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.

Detailed Description
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The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats. Subjects who qualify will be assigned by block randomization to one of four arms: 1 Hz rTMS of the right dorsolateral prefrontal cortex 10 Hz rTMS of the right dorsolateral prefrontal cortex Sham rTMS of the right dorsolateral prefrontal cortex OASIS treatment as usual Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

Official Title
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Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder

Conditions
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PTSD - Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Active Comparator: 1 Hz rTMS
* Other: Active Comparator: 10 Hz rTMS
* Other: Sham Comparator:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant in the OASIS program Willing and able to give informed consent Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50 Males or females between 18-65 years of age Exclusion Criteria: Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use 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 30 days Patients with neurological disorder leading to increased intracranial pressure Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator:1 Hz rTMS<br>Active Comparator: 1 Hz rTMS | Other: Active Comparator: 1 Hz rTMS<br>* 1 Hz rTMS<br>|
| Active Comparator: Active Comparator:10 Hz rTMS<br>Active Comparator:10 Hz rTMS | Other: Active Comparator: 10 Hz rTMS<br>* 10 Hz rTMS<br>|
| Sham Comparator: Sham Comparator:Sham rTMS<br>Sham Comparator: Sham rTMS | Other: Sham Comparator:<br>* Sham rTMS<br>|
| No Intervention: OASIS treatment as usual<br>OASIS treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4 | Clinician Administered PSTD Scale (CAPS) | Baseline and Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAPS - Clinician Administered PTSD Scale, rTMS - repetitive transcranial magnetic stimulation