<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/NCT03014362</url>
  </required_header>
  <id_info>
    <org_study_id>1604023</org_study_id>
    <nct_id>NCT03014362</nct_id>
  </id_info>
  <brief_title>TMS for Suicidal Crisis in Active Duty SMs</brief_title>
  <acronym>TMS4SI</acronym>
  <official_title>Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisenhower Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Congressionally Directed Medical Research Programs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Geneva Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eisenhower Army Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation&#xD;
      (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a&#xD;
      treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with&#xD;
      fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and&#xD;
      medication therapies. There will be 6 months of follow-up, in order to establish the ongoing&#xD;
      and lasting therapeutic effect of TMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The programmatic-level objective of the study is to address the goals of the Army STARRS&#xD;
      Program and the Suicide Prevention for America's Veterans Act through implementation of an&#xD;
      effective acute treatment for patients psychiatrically admitted in suicidal crisis as well as&#xD;
      other patients at high-risk for suicide. This is achieved by application of TMS, which&#xD;
      provides a treatment for suicidal crisis that is quicker, less invasive, better tolerated,&#xD;
      and with fewer side effects and less incapacitation than current treatments such as ECT and&#xD;
      pharmacologic therapies. A recent study led by the senior consultant of this proposal&#xD;
      demonstrated tolerance and efficacy for a new, high-dose regimen of TMS in a VA population&#xD;
      with an average age of 47. The objective of the proposed study is to extend the application&#xD;
      of TMS to a younger population of Active Duty Service Members (SM) in order to demonstrate&#xD;
      efficacy for returning veterans of the Middle East wars, in particular, as well as the&#xD;
      civilian young adult population. TMS dosage in the proposed study is recalibrated to&#xD;
      commercially-standard levels in order to provide consistency with devices currently in&#xD;
      clinical operation. In addition, follow-up in the proposed study continues for 6 months in&#xD;
      order to establish persistence and durability of the therapeutic effect of TMS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">September 10, 2021</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Suicidal Ideation (Acute)</measure>
    <time_frame>Change over the active treatment course ie. the 3 days of active treatment</time_frame>
    <description>The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Suicide</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicidal Impulses</condition>
  <condition>Suicidal Intention</condition>
  <condition>Suicidal and Self-Injurious Behavior</condition>
  <condition>Suicidal Depression</condition>
  <arm_group>
    <arm_group_label>TMS active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neuronetics NeuroStar XPLOR magnetic stimulator - Active;&#xD;
Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.&#xD;
Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC (Standard of Care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Neuronetics NeuroStar XPLOR magnetic stimulator - Sham;&#xD;
Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuronetics NeuroStar XPLOR magnetic stimulator - Active</intervention_name>
    <description>Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.&#xD;
Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.</description>
    <arm_group_label>TMS active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuronetics NeuroStar XPLOR magnetic stimulator - Sham</intervention_name>
    <description>Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.</description>
    <arm_group_label>TMS sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Active Duty SMs (regardless of sex, ethnicity, sexual or religious orientation)&#xD;
             who are admitted to Eisenhower Army Medical Center (EAMC) Inpatient Psychiatric&#xD;
             Service (IPS) with active suicidality or elevated risk for suicide regardless of most&#xD;
             psychiatric diagnostic co-morbidity (see exclusion criteria). This includes in-patient&#xD;
             admissions for suicidality and outpatient SMs with a Columbia-Suicide Severity Rating&#xD;
             Scale (C-SSRS) score ≥3.&#xD;
&#xD;
          -  Age 18 to 60&#xD;
&#xD;
          -  Able to speak and read English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combative with staff.&#xD;
&#xD;
          -  Comatose/catatonia.&#xD;
&#xD;
          -  Incapacity owing to active mania or psychosis.&#xD;
&#xD;
          -  Epilepsy, multiple sclerosis, or cerebrovascular accident.&#xD;
&#xD;
          -  Non-removable metal in the head (Shrapnel; plates, aneurysm coils/clips; metal tattoos&#xD;
             etc.)&#xD;
&#xD;
          -  Implantable devices (pacemakers, stimulators, etc.)&#xD;
&#xD;
          -  Schizophrenic or borderline personality.&#xD;
&#xD;
          -  Positive screen for pregnancy.&#xD;
&#xD;
          -  Already receiving TMS as a treatment for depression.&#xD;
&#xD;
          -  Non-English reading and speaking subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher E Hines, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eisenhower Army Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eisenhower Army Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>March 28, 2022</results_first_submitted>
  <results_first_submitted_qc>September 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2022</results_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eisenhower Army Medical Center</investigator_affiliation>
    <investigator_full_name>Christopher Hines</investigator_full_name>
    <investigator_title>Chief, DDEAMC Outpatient Behavioral Health</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03014362/Prot_007.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03014362/SAP_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TMSactive</title>
          <description>TMSactive</description>
        </group>
        <group group_id="P2">
          <title>TMSsham</title>
          <description>TMSsham</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TMSactive</title>
          <description>TMSactive</description>
        </group>
        <group group_id="B2">
          <title>TMSsham</title>
          <description>TMSsham</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.3" spread="6.9"/>
                    <measurement group_id="B2" value="26.5" spread="6.4"/>
                    <measurement group_id="B3" value="27.4" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>demographic</title>
              <category_list>
                <category>
                  <title>black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>white</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Suicidal Ideation (Acute)</title>
        <description>The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.</description>
        <time_frame>Change over the active treatment course ie. the 3 days of active treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TMS Active</title>
            <description>Group receiving active treatment</description>
          </group>
          <group group_id="O2">
            <title>TMSsham</title>
            <description>group receiving sham treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Suicidal Ideation (Acute)</title>
          <description>The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.06"/>
                    <measurement group_id="O2" value="0.12" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>TMS Active</title>
          <description>group receiving active treatment</description>
        </group>
        <group group_id="E2">
          <title>TMS Sham</title>
          <description>group receiving sham treatment</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>pain</sub_title>
                <description>Pain</description>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="59"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christopher E Hines, MD</name_or_title>
      <organization>Walter Reed National Military Medical Center</organization>
      <phone>301-319-8122</phone>
      <email>christopher.e.hines.civ@mail.mil</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03014362
org study id: 1604023
nct id: NCT03014362
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation
      (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a
      treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with
      fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and
      medication therapies. There will be 6 months of follow-up, in order to establish the ongoing
      and lasting therapeutic effect of TMS.
The programmatic-level objective of the study is to address the goals of the Army STARRS
      Program and the Suicide Prevention for America's Veterans Act through implementation of an
      effective acute treatment for patients psychiatrically admitted in suicidal crisis as well as
      other patients at high-risk for suicide. This is achieved by application of TMS, which
      provides a treatment for suicidal crisis that is quicker, less invasive, better tolerated,
      and with fewer side effects and less incapacitation than current treatments such as ECT and
      pharmacologic therapies. A recent study led by the senior consultant of this proposal
      demonstrated tolerance and efficacy for a new, high-dose regimen of TMS in a VA population
      with an average age of 47. The objective of the proposed study is to extend the application
      of TMS to a younger population of Active Duty Service Members (SM) in order to demonstrate
      efficacy for returning veterans of the Middle East wars, in particular, as well as the
      civilian young adult population. TMS dosage in the proposed study is recalibrated to
      commercially-standard levels in order to provide consistency with devices currently in
      clinical operation. In addition, follow-up in the proposed study continues for 6 months in
      order to establish persistence and durability of the therapeutic effect of TMS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Suicidal Ideation (Acute)
time frame: Change over the active treatment course ie. the 3 days of active treatment
description: The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.
arm group label: TMS active
arm group type: Active Comparator
description: Neuronetics NeuroStar XPLOR magnetic stimulator - Active;
Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.
Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC (Standard of Care).
arm group label: TMS sham
arm group type: Sham Comparator
description: Neuronetics NeuroStar XPLOR magnetic stimulator - Sham;
Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
intervention type: Device
intervention name: Neuronetics NeuroStar XPLOR magnetic stimulator - Active
description: Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.
Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
arm group label: TMS active
intervention type: Device
intervention name: Neuronetics NeuroStar XPLOR magnetic stimulator - Sham
description: Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
arm group label: TMS sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Christopher E Hines, MD
role: Principal Investigator
affiliation: Eisenhower Army Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Eisenhower Army Medical Center
investigator full name: Christopher Hines
investigator title: Chief, DDEAMC Outpatient Behavioral Health
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Self-Injurious Behavior
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 