<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/NCT03017924</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7948</org_study_id>
    <nct_id>NCT03017924</nct_id>
  </id_info>
  <brief_title>Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure</brief_title>
  <acronym>BLAST</acronym>
  <official_title>Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to monitor changes in brain structure and function between the&#xD;
      pre-training and post-training, in a population of tactical team members wearing the Device&#xD;
      and compared to a similar population not wearing the device. Secondly, the purpose is to&#xD;
      determine the protection of the device relative to amount and magnitude of sustained head&#xD;
      impacts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate the effectiveness of this device in tactical team members exposed&#xD;
      to blast waves during tactical training. Subjects participating in this study will be&#xD;
      randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2)&#xD;
      Non-device wearing during the tactical training. The helmets of all participants will be&#xD;
      outfitted with an accelerometer which will measure the magnitude of every concussive blast&#xD;
      wave sustained by the subject. Effectiveness of the device will be determined via differences&#xD;
      in brain MRI and EEG, vision and hearing testing prior to and following standardized&#xD;
      breaching and diversionary device scenario training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blast Explosive Waves Experienced During the Training</measure>
    <time_frame>single breacher training day</time_frame>
    <description>The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Peak Pressure Differences Between Groups</measure>
    <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
    <description>between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar</measure>
    <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
    <description>between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DP-NF Value (Reported in Hz)</measure>
    <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
    <description>pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Q collar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that will wear the Q collar during the breacher training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No collar</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects that will not wear the Q collar during the breacher training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q collar</intervention_name>
    <description>q-collar concussion prevention device</description>
    <arm_group_label>Q collar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal healthy volunteer&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  History of neurological deficits, previous cerebral infarction, or severe head trauma&#xD;
             as indicated through pre-tactical training screening:&#xD;
&#xD;
          -  Medical contraindications to restriction of venous outflow via the internal jugular&#xD;
             veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)&#xD;
&#xD;
          -  Glaucoma (Narrow Angle or Normal Tension)&#xD;
&#xD;
          -  Hydrocephalus&#xD;
&#xD;
          -  Recent penetrating brain trauma (within 6 months)&#xD;
&#xD;
          -  Known carotid hypersensitivity&#xD;
&#xD;
          -  Known increased intracranial pressure&#xD;
&#xD;
          -  Central vein thrombosis&#xD;
&#xD;
          -  Any known airway obstruction&#xD;
&#xD;
          -  Any known seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory D Myer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinanti Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>July 28, 2020</results_first_submitted>
  <results_first_submitted_qc>January 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2021</results_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03017924/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03017924/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Collar Group</title>
          <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
        </group>
        <group group_id="P2">
          <title>Non-Collar Group</title>
          <description>Subjects that will not wear the Q collar during the breacher training</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Collar Group</title>
          <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
        </group>
        <group group_id="B2">
          <title>Non-Collar Group</title>
          <description>Subjects that will not wear the Q collar during the breacher training</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="12"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.72" spread="6.79"/>
                    <measurement group_id="B2" value="48.81" spread="10.37"/>
                    <measurement group_id="B3" value="44.27" spread="8.58"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</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>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99.10" spread="17.58"/>
                    <measurement group_id="B2" value="93.88" spread="15.10"/>
                    <measurement group_id="B3" value="96.49" spread="16.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blast Explosive Waves Experienced During the Training</title>
        <description>The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing</description>
        <time_frame>single breacher training day</time_frame>
        <population>some subjects had head motion during the scan</population>
        <group_list>
          <group group_id="O1">
            <title>Collar Group</title>
            <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
          </group>
          <group group_id="O2">
            <title>Non-Collar Group</title>
            <description>Subjects that will not wear the Q collar during the breacher training</description>
          </group>
        </group_list>
        <measure>
          <title>Blast Explosive Waves Experienced During the Training</title>
          <description>The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing</description>
          <population>some subjects had head motion during the scan</population>
          <units>number of blasts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of blasts N-Back fMRI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="3.37"/>
                    <measurement group_id="O2" value="4.29" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of blasts rs fMRI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="3.19"/>
                    <measurement group_id="O2" value="4.0" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Peak Pressure Differences Between Groups</title>
        <description>between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI</description>
        <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
        <population>some subjects had head motion</population>
        <group_list>
          <group group_id="O1">
            <title>Q Collar</title>
            <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
          </group>
          <group group_id="O2">
            <title>No Collar</title>
            <description>Subjects that will not wear the Q collar during the breacher training</description>
          </group>
        </group_list>
        <measure>
          <title>Average Peak Pressure Differences Between Groups</title>
          <description>between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI</description>
          <population>some subjects had head motion</population>
          <units>pounds per square inch</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>N-Back fMRI Average peak pressure (psi)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.44"/>
                    <measurement group_id="O2" value="1.99" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>rs fMRI Average peak pressure (psi)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.42"/>
                    <measurement group_id="O2" value="1.81" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar</title>
        <description>between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions</description>
        <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
        <population>All subject data available for this measure - no data lost due to head motion</population>
        <group_list>
          <group group_id="O1">
            <title>Collar Group</title>
            <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
          </group>
          <group group_id="O2">
            <title>Non-Collar Group</title>
            <description>Subjects that will not wear the Q collar during the breacher training</description>
          </group>
        </group_list>
        <measure>
          <title>Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar</title>
          <description>between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions</description>
          <population>All subject data available for this measure - no data lost due to head motion</population>
          <units>units on a scale (psi*ms)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>n-Back fMRI total impulse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" spread="4.19"/>
                    <measurement group_id="O2" value="7.67" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>rs FMRI total impulse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="4.08"/>
                    <measurement group_id="O2" value="6.95" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in DP-NF Value (Reported in Hz)</title>
        <description>pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz</description>
        <time_frame>Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.</time_frame>
        <population>all subject data available for this analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Collar Group</title>
            <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
          </group>
          <group group_id="O2">
            <title>Non-Collar Group</title>
            <description>Subjects that will not wear the Q collar during the breacher training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in DP-NF Value (Reported in Hz)</title>
          <description>pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz</description>
          <population>all subject data available for this analysis</population>
          <units>Change in pre to post Dp (reported in Hz</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2000 Hz right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="5.10"/>
                    <measurement group_id="O2" value="0.64" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2000 Hz Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="6.91"/>
                    <measurement group_id="O2" value="-0.5" spread="6.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3000 Hz Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.15" spread="11.36"/>
                    <measurement group_id="O2" value="-1.44" spread="6.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3000 Hz Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="10.28"/>
                    <measurement group_id="O2" value="-1.29" spread="10.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4000 Hz right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.63" spread="6.48"/>
                    <measurement group_id="O2" value="-2.01" spread="6.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4000 Hz left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="7.57"/>
                    <measurement group_id="O2" value="2.57" spread="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6000 Hz right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="10.40"/>
                    <measurement group_id="O2" value="-1.29" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6000 Hz left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.68" spread="9.6"/>
                    <measurement group_id="O2" value="3.55" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8000 Hz right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="6.97"/>
                    <measurement group_id="O2" value="1.54" spread="12.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8000 Hz left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="12.21"/>
                    <measurement group_id="O2" value="4.23" spread="9.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Collar Group</title>
          <description>Subjects that will wear the Q collar during the breacher training&#xD;
Q collar: q-collar concussion prevention device</description>
        </group>
        <group group_id="E2">
          <title>Non-Collar Group</title>
          <description>Subjects that will not wear the Q collar during the breacher training</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>Kim Foss</name_or_title>
      <organization>Cincinnati Childrens Hospital</organization>
      <phone>5136365971</phone>
      <email>kim.foss@cchmc.org</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/NCT03017924
org study id: 2016-7948
nct id: NCT03017924
lead sponsor: 
has dmc: Yes
The purpose of the study is to monitor changes in brain structure and function between the
      pre-training and post-training, in a population of tactical team members wearing the Device
      and compared to a similar population not wearing the device. Secondly, the purpose is to
      determine the protection of the device relative to amount and magnitude of sustained head
      impacts.
This study will investigate the effectiveness of this device in tactical team members exposed
      to blast waves during tactical training. Subjects participating in this study will be
      randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2)
      Non-device wearing during the tactical training. The helmets of all participants will be
      outfitted with an accelerometer which will measure the magnitude of every concussive blast
      wave sustained by the subject. Effectiveness of the device will be determined via differences
      in brain MRI and EEG, vision and hearing testing prior to and following standardized
      breaching and diversionary device scenario training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Blast Explosive Waves Experienced During the Training
time frame: single breacher training day
description: The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
measure: Average Peak Pressure Differences Between Groups
time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
description: between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
measure: Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar
time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
description: between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions
measure: Change in DP-NF Value (Reported in Hz)
time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
description: pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz
arm group label: Q collar
arm group type: Experimental
description: Subjects that will wear the Q collar during the breacher training
arm group label: No collar
arm group type: No Intervention
description: Subjects that will not wear the Q collar during the breacher training
intervention type: Device
intervention name: Q collar
description: q-collar concussion prevention device
arm group label: Q collar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Cincinanti Childrens Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 