<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/NCT03777228</url>
  </required_header>
  <id_info>
    <org_study_id>G172NU-S1</org_study_id>
    <nct_id>NCT03777228</nct_id>
  </id_info>
  <brief_title>Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study</brief_title>
  <official_title>Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uniformed Services University of the Health Sciences</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uniformed Services University of the Health Sciences</source>
  <brief_summary>
    <textblock>
      This study was conducted to develop and validate integrated eye tracking and EEG measures for&#xD;
      assessment of mild traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2015</start_date>
  <completion_date type="Actual">March 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Saccadic RT</measure>
    <time_frame>1 day (single time point)</time_frame>
    <description>Saccadic Response Time</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Individuals without traumatic brain injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild TBI</arm_group_label>
    <description>Individuals with mild traumatic brain injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate to Severe TBI</arm_group_label>
    <description>Individual with moderate to severe traumatic brain injury</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited through USUHS, the Walter Reed National Military Medical&#xD;
        Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the&#xD;
        Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the&#xD;
        greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in&#xD;
        the surrounding community, and in clinical settings such as such as concussion clinics,&#xD;
        neurorehabilitation centers, and other local private practices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 -55, ability to use left and right hands and right foot to complete cognitive&#xD;
             and motor tasks without adaptive equipment, and fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of severe TBI, history of neurological illness unrelated to TBI, vision&#xD;
             problems that are uncorrected by contacts or glasses, history of psychotic disorder,&#xD;
             or current homicidal or suicidal ideation or intent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition</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>Brain Concussion</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/NCT03777228
org study id: G172NU-S1
nct id: NCT03777228
lead sponsor: 
This study was conducted to develop and validate integrated eye tracking and EEG measures for
      assessment of mild traumatic brain injury.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Saccadic RT
time frame: 1 day (single time point)
description: Saccadic Response Time
arm group label: Control
description: Individuals without traumatic brain injury
arm group label: Mild TBI
description: Individuals with mild traumatic brain injury
arm group label: Moderate to Severe TBI
description: Individual with moderate to severe traumatic brain injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion