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

Primary Purpose

PTSD - Post Traumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Comparator: 1 Hz rTMS
Active Comparator: 10 Hz rTMS
Sham Comparator:
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 rTMS - repetitive transcranial magnetic stimulation, CAPS - Clinician Administered PTSD Scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    No Intervention

    Arm Label

    Active Comparator:1 Hz rTMS

    Active Comparator:10 Hz rTMS

    Sham Comparator:Sham rTMS

    OASIS treatment as usual

    Arm Description

    Active Comparator: 1 Hz rTMS

    Active Comparator:10 Hz rTMS

    Sham Comparator: Sham rTMS

    OASIS treatment as usual

    Outcomes

    Primary Outcome Measures

    Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
    Clinician Administered PSTD Scale (CAPS)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2014
    Last Updated
    March 12, 2019
    Sponsor
    United States Naval Medical Center, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02369614
    Brief Title
    Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD
    Official Title
    Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Staffing issues
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    March 2019 (Actual)
    Study Completion Date
    March 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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 Hz rTMS of the right dorsolateral prefrontal cortex 10 Hz rTMS of the right dorsolateral prefrontal cortex Sham rTMS of the right dorsolateral prefrontal cortex OASIS treatment as usual Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

    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
    rTMS - repetitive transcranial magnetic stimulation, CAPS - Clinician Administered PTSD Scale

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Comparator:1 Hz rTMS
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator: 1 Hz rTMS
    Arm Title
    Active Comparator:10 Hz rTMS
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator:10 Hz rTMS
    Arm Title
    Sham Comparator:Sham rTMS
    Arm Type
    Sham Comparator
    Arm Description
    Sham Comparator: Sham rTMS
    Arm Title
    OASIS treatment as usual
    Arm Type
    No Intervention
    Arm Description
    OASIS treatment as usual
    Intervention Type
    Other
    Intervention Name(s)
    Active Comparator: 1 Hz rTMS
    Intervention Description
    1 Hz rTMS
    Intervention Type
    Other
    Intervention Name(s)
    Active Comparator: 10 Hz rTMS
    Intervention Description
    10 Hz rTMS
    Intervention Type
    Other
    Intervention Name(s)
    Sham Comparator:
    Intervention Description
    Sham rTMS
    Primary Outcome Measure Information:
    Title
    Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
    Description
    Clinician Administered PSTD Scale (CAPS)
    Time Frame
    Baseline and Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald Hurst, MD
    Organizational Affiliation
    NMCSD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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