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Completed

NCT Number: NCT02873299

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

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

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Key information

Conditions

PTSD, Post Traumatic Stress Disorder Combat Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NMCSD

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 Hz rTMS of the right dorsolateral prefrontal cortex

Other

Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex

20 Hz rTMS of the right dorsolateral prefrontal cortex

Other

Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

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

Acronym: rTMS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2016
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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