<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749967</url>
  </required_header>
  <id_info>
    <org_study_id>D2886-P</org_study_id>
    <secondary_id>RX002886</secondary_id>
    <nct_id>NCT03749967</nct_id>
  </id_info>
  <brief_title>rTMS for Emotional Difficulties in Verterans</brief_title>
  <acronym>rTMS</acronym>
  <official_title>Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose Finding Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple&#xD;
      disorders often co-occur. This complicates the treatment plan for many Veterans, especially&#xD;
      those suffering the most severe dysfunction. This also means that clinical research aimed at&#xD;
      one specific disorder may not be optimized to treat the realworld presentation of&#xD;
      neuropsychiatric illness. The investigators propose in this study to develop a novel,&#xD;
      non-invasive brain stimulation treatment that would promote rehabilitation for Veterans&#xD;
      suffering a wide range of emotional difficulties. More specifically, the investigators&#xD;
      propose to up-regulate the brain circuitry that supports flexible problem solving and&#xD;
      contending with daily demands. Rather than focusing on reducing the symptoms of a specific&#xD;
      disorder to reduce the intrusion into daily life, the investigators propose to augment those&#xD;
      brain circuits that promote adaptive cognition and thus quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose that because rTMS to dlPFC is targeting cognitive neurocircuitry&#xD;
      integral to adaptive cognitive functioning, promoting neuroplasticity in this network with&#xD;
      rTMS could be more precisely optimized to improve quality of life across psychosocial domains&#xD;
      and across neuropsychiatric presentations. The investigators postulate that through&#xD;
      up-regulating cognitive control circuitry with rTMS that an individual would have 1) enhanced&#xD;
      capacity for successfully contending with the shifting contingencies of daily life and 2)&#xD;
      improved ability to regulate intrusive affect and impulses. As a function of these processes&#xD;
      an individual is expected to experience reduced psychosocial impairment. Thus, the&#xD;
      investigators propose that rather than targeting specific symptom reductions in specific&#xD;
      disorders, rTMS could be dosed for efficacy in enhancing psychosocial functioning. Such an&#xD;
      approach has the potential to enhance rehabilitation for far more Veterans suffering a range&#xD;
      of neuropsychiatric conditions.&#xD;
&#xD;
      Aim 1. Establish the dose-response curve for improved psychosocial functioning secondary to&#xD;
      accelerated rTMS in a transdiagnostic anxious and depressed sample of Veterans.&#xD;
&#xD;
      Aim 2. Establish the safety, feasibility, and acceptability of an accelerated delivery&#xD;
      schedule of therapeutic rTMS for improved psychosocial functioning in a transdiagnostic&#xD;
      anxious and depressed sample of Veterans.&#xD;
&#xD;
      Exploratory Aim 3. Establish whether neurocognitive function demonstrates a dose-response&#xD;
      function to accelerated rTMS similar to psychosocial functioning in a transdiagnostic anxious&#xD;
      and depressed sample.&#xD;
&#xD;
      Note: COVID-19 pandemic put a pause on enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Veterans will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of transdiagnostic psychosocial impairment. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All participants will be randomized to 10 different active doses of accelerated, intermittent theta burst rTMS.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inventory of Psychosocial Functioning (IPF)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>The IPF is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains of functioning. It was iteratively developed in 697 male and female Veteran stakeholders to identify relevant domains of functional impairment common in PTSD and related psychiatric dysfunction. Total score range=0-480. Increased scores pre- to 4 weeks post-treatment would indicate improved function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Quality of Life - Brief Form (WHOQOL-BF)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>The WHOQOL-BREF is a 26-item self-assessment form. Questions are rated on a 5 point scale (from 1-5) Likert scale. Reflects four domains: physical, psychological, social and environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Illness Intrusiveness Rating Scale (IIRS)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>The IIRS is a self-report measure of the extent of psychosocial impairment secondary to illness. Total score range=13-91. Decreased scores pre- to 4 weeks post-treatment would indicate improved function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive performance</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>Participants would complete a computerized battery, which includes well-validated computer-adaptations of neuropsychological tests. Tasks assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. Improved performance pre- to 4 weeks post-treatment would indicate improved function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of Depression and Anxious Symptoms (IDAS-II)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>Questions are rated on a scale from 1-5 and covers a wide array of psychological measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Scale for Depression (HAM-D)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; &gt;17 moderate to severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood and Anxiety Symptom Questionnaire (MASQ)</measure>
    <time_frame>4 weeks post-treatment</time_frame>
    <description>Questions designed to assess symptoms of general distress using a 5-point Likert scale ranging from 1&quot;not at all&quot; to 5 &quot;extremely&quot;.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Mental Health</condition>
  <condition>Depression</condition>
  <condition>rTMS</condition>
  <condition>Anxiety</condition>
  <condition>PTSD</condition>
  <condition>Psychosocial Impairment</condition>
  <arm_group>
    <arm_group_label>Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is ten sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is fifteen sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is twenty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is twenty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is thirty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is thirty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is forty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 9</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is forty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is fifty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation (rTMS)</intervention_name>
    <description>MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.</description>
    <arm_group_label>Dose 1</arm_group_label>
    <arm_group_label>Dose 10</arm_group_label>
    <arm_group_label>Dose 2</arm_group_label>
    <arm_group_label>Dose 3</arm_group_label>
    <arm_group_label>Dose 4</arm_group_label>
    <arm_group_label>Dose 5</arm_group_label>
    <arm_group_label>Dose 6</arm_group_label>
    <arm_group_label>Dose 7</arm_group_label>
    <arm_group_label>Dose 8</arm_group_label>
    <arm_group_label>Dose 9</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A negative urine pregnancy test, if female subject of childbearing potential.&#xD;
&#xD;
          -  Able to speak English and complete study forms, adhere to treatment regimens, and be&#xD;
             willing to return for regular visits.&#xD;
&#xD;
          -  After full explanation of the study, willingness of participant is demonstrated by&#xD;
             signing the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically unstable medical disease:&#xD;
&#xD;
               -  cardiovascular&#xD;
&#xD;
               -  renal&#xD;
&#xD;
               -  gastrointestinal&#xD;
&#xD;
               -  pulmonary&#xD;
&#xD;
               -  metabolic&#xD;
&#xD;
               -  endocrine&#xD;
&#xD;
               -  other&#xD;
&#xD;
               -  CNS disease deemed progressive&#xD;
&#xD;
               -  Moderate or severe traumatic brain injury (TBI) - (using VA/DoD Clinical Practice&#xD;
                  Guidelines)&#xD;
&#xD;
          -  Pregnant females or those currently breast-feeding.&#xD;
&#xD;
          -  Current or history of schizophrenia or other psychotic disorder, except psychosis not&#xD;
             otherwise specified (NOS) when the presence of sensory hallucinations is clearly&#xD;
             related to the subject's trauma, Bipolar Type I disorder, or dementia&#xD;
&#xD;
               -  vascular&#xD;
&#xD;
               -  Alzheimer's disease&#xD;
&#xD;
               -  other types)&#xD;
&#xD;
          -  Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6&#xD;
             days of study entry, with the exception of alcohol use disorder, which, at the&#xD;
             discretion of the study team, may be permitted.&#xD;
&#xD;
               -  See further explanation under protection from risk.&#xD;
&#xD;
          -  Active participation or plan for enrollment in another evidence-based&#xD;
             psychotherapeutic clinical trial&#xD;
&#xD;
               -  Participation in other psychotherapeutic modalities must have been stable for 3&#xD;
                  months prior to enrollment and must remain stable throughout participation.&#xD;
&#xD;
          -  Currently taking medications that have short half-lives, lower the seizure threshold,&#xD;
             and do not have evidence of antidepressant efficacy. These include:&#xD;
&#xD;
               -  high dose theophylline or stimulants such as methylphenidate&#xD;
&#xD;
               -  patients taking bupropion must be on a stable dose and take less than or equal to&#xD;
                  300 mg/day. Stable means the same dose for 5 half-lives.&#xD;
&#xD;
          -  An implanted device in subject's head (shunt, cochlear implant) and/or metal in&#xD;
             subject's head (other than dental implant).&#xD;
&#xD;
        History of seizures or a seizure disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa M. McTeague, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ralph H. Johnson VA Medical Center, Charleston, SC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa M McTeague, PhD</last_name>
    <phone>(843) 577-5011</phone>
    <email>Lisa.Mcteague@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ralph H. Johnson VA Medical Center, Charleston, SC</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401-5703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa M McTeague, PhD</last_name>
      <phone>843-577-5011</phone>
      <email>Lisa.Mcteague@va.gov</email>
    </contact>
    <investigator>
      <last_name>Lisa M. McTeague, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749967
org study id: D2886-P
secondary id: RX002886
nct id: NCT03749967
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple
      disorders often co-occur. This complicates the treatment plan for many Veterans, especially
      those suffering the most severe dysfunction. This also means that clinical research aimed at
      one specific disorder may not be optimized to treat the realworld presentation of
      neuropsychiatric illness. The investigators propose in this study to develop a novel,
      non-invasive brain stimulation treatment that would promote rehabilitation for Veterans
      suffering a wide range of emotional difficulties. More specifically, the investigators
      propose to up-regulate the brain circuitry that supports flexible problem solving and
      contending with daily demands. Rather than focusing on reducing the symptoms of a specific
      disorder to reduce the intrusion into daily life, the investigators propose to augment those
      brain circuits that promote adaptive cognition and thus quality of life.
The investigators propose that because rTMS to dlPFC is targeting cognitive neurocircuitry
      integral to adaptive cognitive functioning, promoting neuroplasticity in this network with
      rTMS could be more precisely optimized to improve quality of life across psychosocial domains
      and across neuropsychiatric presentations. The investigators postulate that through
      up-regulating cognitive control circuitry with rTMS that an individual would have 1) enhanced
      capacity for successfully contending with the shifting contingencies of daily life and 2)
      improved ability to regulate intrusive affect and impulses. As a function of these processes
      an individual is expected to experience reduced psychosocial impairment. Thus, the
      investigators propose that rather than targeting specific symptom reductions in specific
      disorders, rTMS could be dosed for efficacy in enhancing psychosocial functioning. Such an
      approach has the potential to enhance rehabilitation for far more Veterans suffering a range
      of neuropsychiatric conditions.

      Aim 1. Establish the dose-response curve for improved psychosocial functioning secondary to
      accelerated rTMS in a transdiagnostic anxious and depressed sample of Veterans.

      Aim 2. Establish the safety, feasibility, and acceptability of an accelerated delivery
      schedule of therapeutic rTMS for improved psychosocial functioning in a transdiagnostic
      anxious and depressed sample of Veterans.

      Exploratory Aim 3. Establish whether neurocognitive function demonstrates a dose-response
      function to accelerated rTMS similar to psychosocial functioning in a transdiagnostic anxious
      and depressed sample.

      Note: COVID-19 pandemic put a pause on enrollment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Veterans will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of transdiagnostic psychosocial impairment. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects.
primary purpose: Treatment
masking: Single (Participant)
masking description: All participants will be randomized to 10 different active doses of accelerated, intermittent theta burst rTMS.
measure: Inventory of Psychosocial Functioning (IPF)
time frame: 4 weeks post-treatment
description: The IPF is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains of functioning. It was iteratively developed in 697 male and female Veteran stakeholders to identify relevant domains of functional impairment common in PTSD and related psychiatric dysfunction. Total score range=0-480. Increased scores pre- to 4 weeks post-treatment would indicate improved function.
measure: World Health Organization Quality of Life - Brief Form (WHOQOL-BF)
time frame: 4 weeks post-treatment
description: The WHOQOL-BREF is a 26-item self-assessment form. Questions are rated on a 5 point scale (from 1-5) Likert scale. Reflects four domains: physical, psychological, social and environment.
measure: Illness Intrusiveness Rating Scale (IIRS)
time frame: 4 weeks post-treatment
description: The IIRS is a self-report measure of the extent of psychosocial impairment secondary to illness. Total score range=13-91. Decreased scores pre- to 4 weeks post-treatment would indicate improved function.
measure: Neurocognitive performance
time frame: 4 weeks post-treatment
description: Participants would complete a computerized battery, which includes well-validated computer-adaptations of neuropsychological tests. Tasks assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. Improved performance pre- to 4 weeks post-treatment would indicate improved function.
measure: Inventory of Depression and Anxious Symptoms (IDAS-II)
time frame: 4 weeks post-treatment
description: Questions are rated on a scale from 1-5 and covers a wide array of psychological measures
measure: Hamilton Scale for Depression (HAM-D)
time frame: 4 weeks post-treatment
description: Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.
measure: Mood and Anxiety Symptom Questionnaire (MASQ)
time frame: 4 weeks post-treatment
description: Questions designed to assess symptoms of general distress using a 5-point Likert scale ranging from 1"not at all" to 5 "extremely".
arm group label: Dose 1
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 2
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is ten sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 3
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is fifteen sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 4
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is twenty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 5
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is twenty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 6
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is thirty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 7
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is thirty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 8
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is forty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 9
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is forty-five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
arm group label: Dose 10
arm group type: Experimental
description: All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is fifty sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation (rTMS)
description: MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
arm group label: Dose 1
arm group label: Dose 10
arm group label: Dose 2
arm group label: Dose 3
arm group label: Dose 4
arm group label: Dose 5
arm group label: Dose 6
arm group label: Dose 7
arm group label: Dose 8
arm group label: Dose 9
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa M. McTeague, PhD
role: Principal Investigator
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
last name: Lisa M McTeague, PhD
phone: (843) 577-5011
email: Lisa.Mcteague@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No