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

United States Naval Medical Center, San Diego30 enrolled

Overview

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.

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. 1 Hz rTMS of the right dorsolateral prefrontal cortex 2. 10 Hz rTMS of the right dorsolateral prefrontal cortex 3. Sham rTMS of the right dorsolateral prefrontal cortex 4. OASIS treatment as usual Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

PTSD - Post Traumatic Stress Disorder

Interventions

Active Comparator: 1 Hz rTMSOTHER

1 Hz rTMS

Active Comparator: 10 Hz rTMSOTHER

10 Hz rTMS

Sham Comparator:OTHER

Sham rTMS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4

Clinician Administered PSTD Scale (CAPS)

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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