<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/NCT01733641</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00052187</org_study_id>
    <nct_id>NCT01733641</nct_id>
  </id_info>
  <brief_title>Test-Retest Reliability in DETECT</brief_title>
  <official_title>Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy volunteers without concussion, currently participating in non-or-limited contact&#xD;
      sports teams at Emory University will undergo Display Enhanced Testing for Concussion and&#xD;
      mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and&#xD;
      day 90. Prior to enrollment participants will be allocated to the test-retest arm or the&#xD;
      exercise arm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Limited eligible sample size for study outcomes&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Primary Objective is to assess the reliability of the DETECT cognitive assessment tool, as measured by changes in DETECT scores from baseline in non-injured athletes.</measure>
    <time_frame>90 days</time_frame>
    <description>Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days.</description>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Reliability Properties of a Concussion Screening Tool</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteer athletes without concussion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; or = 16&#xD;
&#xD;
          -  eligible for active participation during the National Collegiate Athletic Association&#xD;
             (NCAA) season or member of the 2011 - 2012 or 2012-2013 club team&#xD;
&#xD;
          -  Participation in a non or minimal contact sport&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; age 16&#xD;
&#xD;
          -  history of concussion in the previous 6 months&#xD;
&#xD;
          -  any of the following: learning disabilities, attention deficient disorder, attention&#xD;
             deficit hyperactivity disorder, depression or other psychiatric disorder, sleep apnea,&#xD;
             seizure disorder, migraine headaches, previous central nervous system (CNS) surgery&#xD;
&#xD;
          -  chronic drug or alcohol use; or drug or alcohol use with the previous 24 hours&#xD;
&#xD;
          -  inability to complete the study protocol (90 days)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Tamara Espinoza, MD</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01733641
org study id: IRB00052187
nct id: NCT01733641
lead sponsor: 
has dmc: No
Healthy volunteers without concussion, currently participating in non-or-limited contact
      sports teams at Emory University will undergo Display Enhanced Testing for Concussion and
      mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and
      day 90. Prior to enrollment participants will be allocated to the test-retest arm or the
      exercise arm.
observational model: Cohort
time perspective: Prospective
measure: Primary Objective is to assess the reliability of the DETECT cognitive assessment tool, as measured by changes in DETECT scores from baseline in non-injured athletes.
time frame: 90 days
description: Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Tamara Espinoza, MD
investigator title: Instructor