<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/NCT03014492</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0988</org_study_id>
    <nct_id>NCT03014492</nct_id>
  </id_info>
  <brief_title>Concussion Prevention in Female Soccer Athletes</brief_title>
  <official_title>Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females</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 longitudinal changes in brain structure and function&#xD;
      between the preseason and postseason, in a population of soccer playing athletes wearing the&#xD;
      Device and compared to a similar population not wearing the device. Secondly, the purpose is&#xD;
      to 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 high school athletes playing&#xD;
      a non-helmeted sport such as soccer. Athletes participating in this study will be randomly&#xD;
      assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing&#xD;
      during the season. This study will focus on the use and effectiveness of the device solely in&#xD;
      females, as male football and hockey players have previously been investigated. All&#xD;
      participants will be outfitted with an adhesive patch-like accelerometer (which will be&#xD;
      placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which&#xD;
      will measure the magnitude of every impact to the head sustained by the athlete.&#xD;
      Effectiveness of the device will be determined via differences in longitudinal brain imaging&#xD;
      and functional testing following competitive soccer participation. A subset of athletes who&#xD;
      report a diagnosed concussion will also receive additional brain neuroanatomical and&#xD;
      neurophysiological testing within a week following the diagnosed concussive event. At each of&#xD;
      these time points participants will also undergo various neurocognitive assessments&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-season to Post-season DTI Percentage Change</measure>
    <time_frame>6 months</time_frame>
    <description>Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Completing EEG</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants completing EEG</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Concussion, Mild</condition>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>Collar Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soccer girls that wore the collar device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Collar Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>soccer girls that did not wear the collar</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q Collar</intervention_name>
    <description>Collar designed to mitigate slosh in the brain</description>
    <arm_group_label>Collar Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Normal healthy volunteer&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Must be 14 years or older and a participant on a high school soccer team&#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-season 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>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</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>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinanti 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>September 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>July 24, 2020</results_first_submitted>
  <results_first_submitted_qc>October 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2020</results_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</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>
  <provided_document_section>
    <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>February 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03014492/ICF_000.pdf</document_url>
    </provided_document>
    <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>March 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03014492/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Collar Group</title>
          <description>Soccer girls that wore the collar device&#xD;
Q Collar: Collar designed to mitigate slosh in the brain</description>
        </group>
        <group group_id="P2">
          <title>No Collar Group</title>
          <description>soccer girls that did not wear the collar</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Collar Group</title>
          <description>Soccer girls that wore the collar device&#xD;
Q Collar: Collar designed to mitigate slosh in the brain</description>
        </group>
        <group group_id="B2">
          <title>No Collar Group</title>
          <description>soccer girls that did not wear the collar</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="44"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="44"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 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>
                  <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>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="44"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="44"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of participant</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="44"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.06" spread="1.10"/>
                    <measurement group_id="B2" value="15.95" spread="1.04"/>
                    <measurement group_id="B3" value="16.0" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pre-season to Post-season DTI Percentage Change</title>
        <description>Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Collar Group</title>
            <description>Soccer girls that wore the collar device&#xD;
Q Collar: Collar designed to mitigate slosh in the brain</description>
          </group>
          <group group_id="O2">
            <title>No Collar Group</title>
            <description>soccer girls that did not wear the collar</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-season to Post-season DTI Percentage Change</title>
          <description>Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.</description>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="1.99"/>
                    <measurement group_id="O2" value="-1.27" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="2.23"/>
                    <measurement group_id="O2" value="2.83" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="2.23"/>
                    <measurement group_id="O2" value="2.58" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="2.72"/>
                    <measurement group_id="O2" value="3.52" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Completing EEG</title>
        <description>Number of participants completing EEG</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Collar Group</title>
            <description>Soccer girls that wore the collar device&#xD;
Q Collar: Collar designed to mitigate slosh in the brain</description>
          </group>
          <group group_id="O2">
            <title>No Collar Group</title>
            <description>soccer girls that did not wear the collar</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completing EEG</title>
          <description>Number of participants completing EEG</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="28"/>
                  </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>Collar Group</title>
          <description>Soccer girls that wore the collar device&#xD;
Q Collar: Collar designed to mitigate slosh in the brain</description>
        </group>
        <group group_id="E2">
          <title>No Collar Group</title>
          <description>soccer girls that did not wear the collar</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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Cincinanti 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/NCT03014492
org study id: 2016-0988
nct id: NCT03014492
lead sponsor: 
has dmc: Yes
The purpose of the study is to monitor longitudinal changes in brain structure and function
      between the preseason and postseason, in a population of soccer playing athletes 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 high school athletes playing
      a non-helmeted sport such as soccer. Athletes participating in this study will be randomly
      assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing
      during the season. This study will focus on the use and effectiveness of the device solely in
      females, as male football and hockey players have previously been investigated. All
      participants will be outfitted with an adhesive patch-like accelerometer (which will be
      placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which
      will measure the magnitude of every impact to the head sustained by the athlete.
      Effectiveness of the device will be determined via differences in longitudinal brain imaging
      and functional testing following competitive soccer participation. A subset of athletes who
      report a diagnosed concussion will also receive additional brain neuroanatomical and
      neurophysiological testing within a week following the diagnosed concussive event. At each of
      these time points participants will also undergo various neurocognitive assessments
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pre-season to Post-season DTI Percentage Change
time frame: 6 months
description: Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
measure: Number of Participants Completing EEG
time frame: 6 months
description: Number of participants completing EEG
arm group label: Collar Group
arm group type: Experimental
description: Soccer girls that wore the collar device
arm group label: No Collar Group
arm group type: No Intervention
description: soccer girls that did not wear the collar
intervention type: Device
intervention name: Q Collar
description: Collar designed to mitigate slosh in the brain
arm group label: Collar Group
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 