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

August 18, 2016 updated by: United States Naval Medical Center, San Diego

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

The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • NMCSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale , CAPS
Time Frame: day 10
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
Time Frame: week 24
The PCL consists of 17 items measured on a 5-point Likert scale ranging from "not at all" to "extremely
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Investigators

  • Principal Investigator: Marc A Capobianco, MD, DFAPA, NMCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2011.0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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