<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/NCT03761641</url>
  </required_header>
  <id_info>
    <org_study_id>012015-030</org_study_id>
    <nct_id>NCT03761641</nct_id>
  </id_info>
  <brief_title>Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment</brief_title>
  <official_title>Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol is aimed at collecting oculomotor response data from a variety of brain&#xD;
      injuries and impairments, and to secondarily evaluate the functionality and ease of use of&#xD;
      the NeuroTriage device in the ED in patients with any presumed brain injury and/or&#xD;
      impairment. For example, prior studies in adolescents with a concussion have shown that they&#xD;
      tend to overshoot the pattern when asked to follow the movement of the lights in the&#xD;
      binoculars&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study personnel will identify potential subjects in the ED, hospital and ICU during &quot;peak&#xD;
      hours&quot; as appropriate through conferring with medical records, trauma logs, triage notes, and&#xD;
      head CT, MRI, and other brain imaging orders as well as on-duty doctors and nurses to&#xD;
      identify potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a&#xD;
      review of the potential subject's medical records, such as mechanism of injury or impairment,&#xD;
      extent of non-head injuries, prior medical history, and prior clinical visits at the center&#xD;
      of care. When a potential subject is identified and has been screened against the primary set&#xD;
      of inclusion/exclusion criteria, they will be approached about the study.&#xD;
&#xD;
      Prior to enrolling a subject, the research personnel will screen the subject for competency&#xD;
      to provide informed consent. This is necessary because, by its very nature, suspected brain&#xD;
      injury patients may or may not be able to initially provide informed consent. The Galveston&#xD;
      Orientation and Amnesia Test (GOAT) will be used as the standard assessment instrument for&#xD;
      this screening. A score of 75 or greater on the GOAT would indicate that the subject is&#xD;
      competent to provide informed consent. If the subject scores &lt; 75 on the GOAT, then consent&#xD;
      must be provided by a Legally Authorized Representative (LAR). This is a threshold of&#xD;
      competency that has been used in previous studies here at UTSW.&#xD;
&#xD;
      Potential subjects that pass the GOAT will be given time to read the Consent Form and to&#xD;
      consult with family members who may be present or by phone. If the subject agrees to&#xD;
      participate, then they will sign the appropriate forms. A copy of the form will be given to&#xD;
      the subject. The NeuroTriage and GOAT will then be serially performed on the patient no more&#xD;
      than once every two hours (particularly in the ED, where the stay is often short) or with&#xD;
      changes in neurological status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Calibration of Neurotriage Device</measure>
    <time_frame>Through study completion, 1 year</time_frame>
    <description>Evaluate the number of rehabilitation device failure as reported by study team</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enjoyment of Neurotriage Device Use</measure>
    <time_frame>Through Study Completion, 1 year</time_frame>
    <description>Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware, changes will be made based on feedback received from participants.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurotriage</intervention_name>
    <description>NeuroTriage binocular handset monitors pupil dynamics &amp; eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face &amp;cushion between the skin &amp; eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, &amp; dilation velocity. Total pupil dilation testing time is &lt; 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position &amp; movement velocity during these tests. Total saccade-tracking testing takes &lt; 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present to Parkland ED with suspected brain injury greater than 18 years of&#xD;
        age, of an race or gender. Patients will need to be fluent in Spanish or English&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Criteria for Inclusion of Subjects:&#xD;
&#xD;
        One hundred individuals presenting to Parkland Emergency Department, Zale Lipshy and&#xD;
        Clements Hospital for treatment diagnosed to be any form of mild, moderate or severe TBI,&#xD;
        between the ages of 18 and 65 will be given the opportunity to participate in this study.&#xD;
&#xD;
        Patients injury should have occurred within the past 24 hours,and have an acute brain CT&#xD;
        performed based on clinical care. We will enroll patients presenting to the Emergency&#xD;
        Department (ED) with a history of TBI as per American Congress of Rehabilitation&#xD;
        Medicine(ACRM) Criteria, in which the patient has sustained a traumatically induced*&#xD;
        physiological disruption of brain function, as manifested by ≥ one of the following:&#xD;
&#xD;
          -  Any period of loss of consciousness (LOC)&#xD;
&#xD;
          -  Any loss of memory for events (e.g. amnesia) immediately before or after the accident-&#xD;
&#xD;
          -  Any alteration of mental state at the time of the accident (feeling dazed,&#xD;
             disoriented, and/or confused)&#xD;
&#xD;
          -  Focal neurologic deficits that may or may not be permanent&#xD;
&#xD;
        Traumatically induced includes the head being struck, the head striking an object, or the&#xD;
        brain undergoing an acceleration/deceleration movement (e.g. whiplash) without direct&#xD;
        external trauma to the head.&#xD;
&#xD;
        All patients will need to be fluent in English or Spanish and be able to personally provide&#xD;
        informed consent or have a legally authorized representative provide informed consent.&#xD;
&#xD;
        Individuals will not be excluded based on gender or race.&#xD;
&#xD;
        Criteria for Exclusion of Subjects:&#xD;
&#xD;
        Patients who have a penetrating Traumatic Brain Injury or a Spinal Cord Injury with ASIA&#xD;
        score of C or worse will not be eligible for enrollment in this study.&#xD;
&#xD;
          -  Any patients that are already participating in an interventional trial (e.g. drug,&#xD;
             devise or behavioral) will be excluded.&#xD;
&#xD;
          -  Non-English or Spanish speakers will be excluded.&#xD;
&#xD;
          -  Any cognitive defect that limits comprehension of the study procedures and risks&#xD;
             associated will be excluded.&#xD;
&#xD;
          -  Patients with significant polytrauma that would interfere with assessments.&#xD;
&#xD;
          -  Patients that have a significant history of pre-existing conditions that would&#xD;
             interfere assessments (e.g.substance abuse, alcoholism, HIV/AIDS, major transmittable&#xD;
             diseases that may interfere with consent, endstage cancers, learning disabilities, and&#xD;
             developmental disorders).&#xD;
&#xD;
          -  Patients on psychiatric hold or patients with a major debilitating mental health&#xD;
             disorder (e.g. schizophrenia or bipolar disorder) will be excluded as they may&#xD;
             interfere with follow-up and the validity of assessments.&#xD;
&#xD;
          -  Patients with major debilitating neurological disease (e.g. stroke, CVA, dementia,&#xD;
             tumor) impairing baseline awareness,cognition, or validity of follow-up and outcome&#xD;
             assessment.&#xD;
&#xD;
          -  Pregnancy in female subjects and prisoners in custody will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane G Wigginton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Victoria S Warren, RN</last_name>
    <phone>214-648-2387</phone>
    <email>victoria.warren@utsouthwestern.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Parkland Memorial Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria S Warren, RN</last_name>
      <phone>214-648-2523</phone>
      <email>victoria.warren@utsouthwestern.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 19, 2015</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Jane Wigginton</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>
    <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/NCT03761641
org study id: 012015-030
nct id: NCT03761641
lead sponsor: 
has dmc: No
This protocol is aimed at collecting oculomotor response data from a variety of brain
      injuries and impairments, and to secondarily evaluate the functionality and ease of use of
      the NeuroTriage device in the ED in patients with any presumed brain injury and/or
      impairment. For example, prior studies in adolescents with a concussion have shown that they
      tend to overshoot the pattern when asked to follow the movement of the lights in the
      binoculars
Study personnel will identify potential subjects in the ED, hospital and ICU during "peak
      hours" as appropriate through conferring with medical records, trauma logs, triage notes, and
      head CT, MRI, and other brain imaging orders as well as on-duty doctors and nurses to
      identify potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a
      review of the potential subject's medical records, such as mechanism of injury or impairment,
      extent of non-head injuries, prior medical history, and prior clinical visits at the center
      of care. When a potential subject is identified and has been screened against the primary set
      of inclusion/exclusion criteria, they will be approached about the study.

      Prior to enrolling a subject, the research personnel will screen the subject for competency
      to provide informed consent. This is necessary because, by its very nature, suspected brain
      injury patients may or may not be able to initially provide informed consent. The Galveston
      Orientation and Amnesia Test (GOAT) will be used as the standard assessment instrument for
      this screening. A score of 75 or greater on the GOAT would indicate that the subject is
      competent to provide informed consent. If the subject scores < 75 on the GOAT, then consent
      must be provided by a Legally Authorized Representative (LAR). This is a threshold of
      competency that has been used in previous studies here at UTSW.

      Potential subjects that pass the GOAT will be given time to read the Consent Form and to
      consult with family members who may be present or by phone. If the subject agrees to
      participate, then they will sign the appropriate forms. A copy of the form will be given to
      the subject. The NeuroTriage and GOAT will then be serially performed on the patient no more
      than once every two hours (particularly in the ED, where the stay is often short) or with
      changes in neurological status.
observational model: Other
time perspective: Prospective
measure: Calibration of Neurotriage Device
time frame: Through study completion, 1 year
description: Evaluate the number of rehabilitation device failure as reported by study team
measure: Enjoyment of Neurotriage Device Use
time frame: Through Study Completion, 1 year
description: Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware, changes will be made based on feedback received from participants.
intervention type: Other
intervention name: Neurotriage
description: NeuroTriage binocular handset monitors pupil dynamics & eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face &cushion between the skin & eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, & dilation velocity. Total pupil dilation testing time is < 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position & movement velocity during these tests. Total saccade-tracking testing takes < 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Jane G Wigginton, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
last name: Victoria S Warren, RN
phone: 214-648-2387
email: victoria.warren@utsouthwestern.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Jane Wigginton
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries