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

March 12, 2019 updated by: Donald Hurst, United States Naval Medical Center, San Diego

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

No

Genders Eligible for Study

All

Description

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 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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator:1 Hz rTMS
Active Comparator: 1 Hz rTMS
Other: Active Comparator: 1 Hz rTMS
1 Hz rTMS
Active Comparator: Active Comparator:10 Hz rTMS
Other: Active Comparator: 10 Hz rTMS
10 Hz rTMS
Sham Comparator: Sham Comparator:Sham rTMS
Sham Comparator: Sham rTMS
Other: Sham Comparator:
Sham rTMS
No Intervention: OASIS treatment as usual

What is the study measuring?

Primary Outcome Measures

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

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: Donald Hurst, MD, 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

August 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2014.0061

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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