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

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ClinicalTrials.gov Identifier: NCT02873299
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
PTSD, Post Traumatic Stress Disorder Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
Study Start Date : April 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873299


Locations
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United States, California
NMCSD
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Marc A Capobianco, MD, DFAPA NMCSD

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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02873299     History of Changes
Other Study ID Numbers: NMCSD.2011.0025
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by United States Naval Medical Center, San Diego:
PTSD, Post Traumatic Stress Disorder

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders