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

Primary Purpose

PTSD, Post Traumatic Stress Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
10 Hz rTMS of the right dorsolateral prefrontal cortex
20 Hz rTMS of the right dorsolateral prefrontal cortex
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD, Post Traumatic Stress Disorder focused on measuring PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NMCSD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Treatment as usual

rTMS at 10Hz

rTMS at 20Hz

Arm Description

Treatment as usual, wait list control group

10 Hz rTMS of the right dorsolateral prefrontal cortex

20 Hz rTMS of the right dorsolateral prefrontal cortex

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale , CAPS
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.

Secondary Outcome Measures

Posttraumatic Stress Disorder Checklist, PCL
The PCL consists of 17 items measured on a 5-point Likert scale ranging from "not at all" to "extremely

Full Information

First Posted
September 30, 2014
Last Updated
August 18, 2016
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02873299
Brief Title
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD
Acronym
rTMS
Official Title
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Post Traumatic Stress Disorder
Keywords
PTSD, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual, wait list control group
Arm Title
rTMS at 10Hz
Arm Type
Active Comparator
Arm Description
10 Hz rTMS of the right dorsolateral prefrontal cortex
Arm Title
rTMS at 20Hz
Arm Type
Active Comparator
Arm Description
20 Hz rTMS of the right dorsolateral prefrontal cortex
Intervention Type
Other
Intervention Name(s)
10 Hz rTMS of the right dorsolateral prefrontal cortex
Intervention Description
Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
Intervention Type
Other
Intervention Name(s)
20 Hz rTMS of the right dorsolateral prefrontal cortex
Intervention Description
Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale , CAPS
Description
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.
Time Frame
day 10
Secondary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist, PCL
Description
The PCL consists of 17 items measured on a 5-point Likert scale ranging from "not at all" to "extremely
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Capobianco, MD, DFAPA
Organizational Affiliation
NMCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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