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

Early Phase 1

Completed

• Conditions: PTSD, Post Traumatic Stress Disorder

• Registration Number: NCT02873299
• Lead Sponsor: United States Naval Medical Center, San Diego

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-09-30
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-18
• Study First Posted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NMCSD; 🇺🇸 San Diego, California, United States