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

Not Applicable

Terminated

• Conditions: PTSD - Post Traumatic Stress Disorder

• Registration Number: NCT02369614
• Lead Sponsor: United States Naval Medical Center, San Diego

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4	Baseline and Week 4	Clinician Administered PSTD Scale (CAPS)