<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/NCT03249818</url>
  </required_header>
  <id_info>
    <org_study_id>rebiscan-004</org_study_id>
    <nct_id>NCT03249818</nct_id>
  </id_info>
  <brief_title>HITT Device Pilot Testing for Traumatic Brain Injury</brief_title>
  <official_title>Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebiscan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rebiscan, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to collect data from the eyes of traumatic brain injury&#xD;
      (TBI) patients. Patients will look at a green target that will measure the fixation of the&#xD;
      eye for 30 seconds. In that 30 seconds, the location of the green target will change and the&#xD;
      participant is to track, with their eyes, the light as best they can. The device will measure&#xD;
      how well fixation was maintained and the speed of the saccadic movements of the eye. Data&#xD;
      will then be used to determine whether there is correlation between these measures and known&#xD;
      TBI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TBI detection</measure>
    <time_frame>1 day</time_frame>
    <description>Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TBI monitor</measure>
    <time_frame>14 days</time_frame>
    <description>Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Brain Injuries, Traumatic</condition>
  <arm_group>
    <arm_group_label>HITT Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HITT device to scan eyes of participants 3 times (30 seconds each) at time of admittance to hospital for diagnosed traumatic brain injury. If patient is still in hospital 2 weeks post-enrollment, a second set of 3 tests will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HITT device</intervention_name>
    <description>Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.</description>
    <arm_group_label>HITT Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18-40&#xD;
&#xD;
          2. Documented/ verified mild TBI&#xD;
&#xD;
          3. Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time&#xD;
             of study enrollment&#xD;
&#xD;
          4. Injury occurred &lt; 24 hours ago&#xD;
&#xD;
          5. Positive acute brain CT for clinical care&#xD;
&#xD;
          6. Visual acuity/ hearing adequate for testing&#xD;
&#xD;
          7. Fluency in English or Spanish&#xD;
&#xD;
          8. Ability to provide informed consent&#xD;
&#xD;
          9. Enrolled in TRACK-TBI (IRB #: 825503)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Catastrophic polytrauma that would interfere with follow-up and outcome assessment&#xD;
&#xD;
          2. Prisoners or patients in custody&#xD;
&#xD;
          3. Pregnancy in female subjects&#xD;
&#xD;
          4. Patients on psychiatric hold (e.g. 5150, 5250)&#xD;
&#xD;
          5. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar&#xD;
             disorder) that would interfere with follow-up and the validity of outcome assessment&#xD;
&#xD;
          6. Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing&#xD;
             baseline awareness, cognition, or validity of follow-up and outcome assessment&#xD;
&#xD;
          7. Significant history of pre-existing conditions that would interfere with follow-up and&#xD;
             outcome assessment (e.g. substance abuse, alcoholism, HIV/AIDS, major transmittable&#xD;
             diseases that may interfere with consent, end-stage cancers, learning disabilities,&#xD;
             developmental disorders)&#xD;
&#xD;
          8. Low likelihood of follow-up (e.g. participant or family indicating low interest,&#xD;
             homelessness or lack of reliable contacts)&#xD;
&#xD;
          9. Penetrating TBI&#xD;
&#xD;
         10. Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse&#xD;
&#xD;
         11. Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket&#xD;
             (or any fracture to face that would negatively impact eye movement/vision) that would&#xD;
             interfere with ability to complete study-device assessment.&#xD;
&#xD;
         12. History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)&#xD;
&#xD;
         13. Intoxication or chemical impairment at time of examination (upon initial presentation)&#xD;
&#xD;
         14. Evidence on hand-light examination of obvious ocular anomaly or misalignment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramon Diaz-Arrastia, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2018</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 Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Aggregate data and individual test reports will be made available to the HITT device manufacturer to better understand its performance at identifying TBI. Personal identifiable data will not be shared with anyone outside of the University of Pennsylvania.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from first enrolled participant.</ipd_time_frame>
    <ipd_access_criteria>Data will only be shared with researchers involved in the study at the University of Pennsylvania, and only trained staff members at the device manufacturer.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03249818
org study id: rebiscan-004
nct id: NCT03249818
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this research study is to collect data from the eyes of traumatic brain injury
      (TBI) patients. Patients will look at a green target that will measure the fixation of the
      eye for 30 seconds. In that 30 seconds, the location of the green target will change and the
      participant is to track, with their eyes, the light as best they can. The device will measure
      how well fixation was maintained and the speed of the saccadic movements of the eye. Data
      will then be used to determine whether there is correlation between these measures and known
      TBI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: TBI detection
time frame: 1 day
description: Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI
measure: TBI monitor
time frame: 14 days
description: Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI
arm group label: HITT Device
arm group type: Other
description: HITT device to scan eyes of participants 3 times (30 seconds each) at time of admittance to hospital for diagnosed traumatic brain injury. If patient is still in hospital 2 weeks post-enrollment, a second set of 3 tests will be performed
intervention type: Device
intervention name: HITT device
description: Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.
arm group label: HITT Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ramon Diaz-Arrastia, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: Yes
ipd description: Aggregate data and individual test reports will be made available to the HITT device manufacturer to better understand its performance at identifying TBI. Personal identifiable data will not be shared with anyone outside of the University of Pennsylvania.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from first enrolled participant.
ipd access criteria: Data will only be shared with researchers involved in the study at the University of Pennsylvania, and only trained staff members at the device manufacturer.