<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/NCT02189525</url>
  </required_header>
  <id_info>
    <org_study_id>HHC-001</org_study_id>
    <nct_id>NCT02189525</nct_id>
  </id_info>
  <brief_title>Evaluation of Mild TBI in Collegiate Athletes</brief_title>
  <acronym>AWARE</acronym>
  <official_title>AWARE: Mild Traumatic Brain Injury in Collegiate Athletes - A Prospective Study With Blood-based Biomarkers, Advanced Neuroimaging and the Head Impact Telemetry System (HITS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Banyan Biomarkers, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Banyan Biomarkers, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate blood-based biomarkers before and after&#xD;
      sports-induced concussion using neuroimaging and head impact sensor technology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 25, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion</measure>
    <time_frame>Baseline and up to 48 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion</measure>
    <time_frame>Baseline and up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of serum biomarker levels and neuroimaging results to standard clinical measures of concussion in the acute phase of injury and at the completion of collegiate athletic participation</measure>
    <time_frame>Baseline and up to 48 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Sports induced concussion</arm_group_label>
    <description>Exposure to sports induced concussion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Athletic Exertion</arm_group_label>
    <description>Exposure to routine athletic exertion without sports-induced concussion (non-concussion control)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Collegiate atheltes from University of Florida involved in Men's Football, Women's Soccer,&#xD;
        or Women's Lacrosse&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. University of Florida student athlete involved in Men's Football, Men and Women's&#xD;
             Basketball, Men and Women's Swimming, Men and Women's Diving, Women's Soccer, or&#xD;
             Women's Lacrosse or University of Florida student athlete not participating in those&#xD;
             sports who is being treated for a sports-related head injury.&#xD;
&#xD;
          2. Age greater than or equal to 18 years of age.&#xD;
&#xD;
          3. Willing to undergo the Informed Consent Process and provide Informed Consent prior to&#xD;
             enrollment into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is otherwise determined by the Investigator to be medically unsuitable for&#xD;
             participation in the study&#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>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Weber AG, Clugston JR. Concussion Biomarkers Assessed in Collegiate Student-Athletes (BASICS) I: Normative study. Neurology. 2018 Dec 4;91(23):e2109-e2122. doi: 10.1212/WNL.0000000000006613. Epub 2018 Nov 7.</citation>
    <PMID>30404785</PMID>
  </reference>
  <reference>
    <citation>Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Dubose DN, Boone JK, Weber AG, Clugston JR. Concussion BASICS II: Baseline serum biomarkers, head impact exposure, and clinical measures. Neurology. 2018 Dec 4;91(23):e2123-e2132. doi: 10.1212/WNL.0000000000006616. Epub 2018 Nov 7.</citation>
    <PMID>30404782</PMID>
  </reference>
  <reference>
    <citation>Asken BM, Bauer RM, DeKosky ST, Svingos AM, Hromas G, Boone JK, DuBose DN, Hayes RL, Clugston JR. Concussion BASICS III: Serum biomarker changes following sport-related concussion. Neurology. 2018 Dec 4;91(23):e2133-e2143. doi: 10.1212/WNL.0000000000006617. Epub 2018 Nov 7.</citation>
    <PMID>30404786</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>traumatic brain injury</keyword>
  <keyword>sports head injury</keyword>
  <keyword>sports concussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189525
org study id: HHC-001
nct id: NCT02189525
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate blood-based biomarkers before and after
      sports-induced concussion using neuroimaging and head impact sensor technology.
observational model: Cohort
time perspective: Prospective
measure: Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion
time frame: Baseline and up to 48 months
measure: Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion
time frame: Baseline and up to 48 months
measure: Correlation of serum biomarker levels and neuroimaging results to standard clinical measures of concussion in the acute phase of injury and at the completion of collegiate athletic participation
time frame: Baseline and up to 48 months
arm group label: Sports induced concussion
description: Exposure to sports induced concussion
arm group label: Routine Athletic Exertion
description: Exposure to routine athletic exertion without sports-induced concussion (non-concussion control)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Weber AG, Clugston JR. Concussion Biomarkers Assessed in Collegiate Student-Athletes (BASICS) I: Normative study. Neurology. 2018 Dec 4;91(23):e2109-e2122. doi: 10.1212/WNL.0000000000006613. Epub 2018 Nov 7.
PMID: 30404785
citation: Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Dubose DN, Boone JK, Weber AG, Clugston JR. Concussion BASICS II: Baseline serum biomarkers, head impact exposure, and clinical measures. Neurology. 2018 Dec 4;91(23):e2123-e2132. doi: 10.1212/WNL.0000000000006616. Epub 2018 Nov 7.
PMID: 30404782
citation: Asken BM, Bauer RM, DeKosky ST, Svingos AM, Hromas G, Boone JK, DuBose DN, Hayes RL, Clugston JR. Concussion BASICS III: Serum biomarker changes following sport-related concussion. Neurology. 2018 Dec 4;91(23):e2133-e2143. doi: 10.1212/WNL.0000000000006617. Epub 2018 Nov 7.
PMID: 30404786
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries