<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/NCT01728129</url>
  </required_header>
  <id_info>
    <org_study_id>M-10228</org_study_id>
    <nct_id>NCT01728129</nct_id>
  </id_info>
  <brief_title>DANA Compared to MACE in Evaluation of Suspected Acute Concussion</brief_title>
  <official_title>Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Tool to the Military Acute Concussion Evaluation (MACE) in the Evaluation of Suspected Acute Concussion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry M. Jackson Foundation for the Advancement of Military Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Army Medical Research and Development Command</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry M. Jackson Foundation for the Advancement of Military Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE&#xD;
      cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive&#xD;
      for detecting impaired cognitive performance than the MACE cognitive score in the setting of&#xD;
      a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary&#xD;
      purpose of this study is to examine a serial performance on the DANA Rapid exam in those&#xD;
      subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam&#xD;
      will show improvements in performance during the recovery period after concussion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Operations Iraqi Freedom and Enduring Freedom (OIF/OEF), over 60% of combat casualties&#xD;
      have been the result of explosive blasts, and many of these critical injuries involve trauma&#xD;
      to the head. As a result, traumatic brain injury (TBI) has been deemed a &quot;signature wound&quot; of&#xD;
      OIF and OEF. The symptoms of head injuries, particularly of concussion/mild TBI (mTBI), can&#xD;
      be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded&#xD;
      warrior's appropriate medical care. Most first providers in the war theater are medics who&#xD;
      could benefit from an improved diagnostic test to better identify service members with&#xD;
      concussion/mTBI. The MACE cognitive test is heavily weighted towards memory, is not 100%&#xD;
      specific, and does not preclude a diagnosis of concussion being rendered despite a score in&#xD;
      the normal range. Thus, an objective test of neurocognitive function, such as the DANA Rapid,&#xD;
      that can be rapidly administered in theater by a combat medic would be highly beneficial to&#xD;
      accurate clinical diagnosis and timely treatment. The results of the present study will&#xD;
      provide information on the predictive value of the newly developed DANA handheld computer in&#xD;
      assisting in the diagnosis of concussion in service members who have been blast exposed. If&#xD;
      the DANA Rapid exam proves to be equally or more accurate than the MACE in detecting&#xD;
      cognitive deficits, these tests and the handheld computer will also contribute to improved&#xD;
      health care for service members by minimizing the time between injury and diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>72 hours from initial injury</time_frame>
    <description>The primary hypothesis is that an abnormal score on the DANA Rapid will positively identify a greater proportion of concussed individuals than an abnormal cognitive score on the MACE would. Conversely, scores within normal range on the DANA Rapid should be able to rule out cognitive deficits more accurately than a normal score on the MACE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serial Performance</measure>
    <time_frame>72 hours from initial injury</time_frame>
    <description>The secondary hypothesis of the study is that scores on the DANA Rapid exam will improve over time as the subject recovers from concussion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Brain Concussion</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Concussed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who are diagnosed with a concussion by a clinician will be assessed with the MACE and DANA Rapid every 24 hours for up to 72 hours post-injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-concussed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will have been exposed to a potentially concussive event but be clinically evaluated and found not to have sustained a concussion. Control subjects from this arm will take both the MACE and DANA Rapid twice: once within 24 hours of potentially concussive event, and again on the day of return to duty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DANA Rapid</intervention_name>
    <description>The DANA Rapid is a neurocognitive test self-administered on a small handheld computer. The DANA Rapid subtests measure simple reaction time, procedural reaction time, and reaction time sensitivity.</description>
    <arm_group_label>Concussed</arm_group_label>
    <arm_group_label>Non-concussed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MACE</intervention_name>
    <description>The MACE is currently the only standardized and Department of Defense-designated method for the initial evaluation of suspected concussion in military operational settings. The MACE documents the history of the injury-causing incident; assesses cognitive deficits in orientation, immediate memory, concentration, and delayed recalls; and involves a neurological screening by a clinician.</description>
    <arm_group_label>Concussed</arm_group_label>
    <arm_group_label>Non-concussed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty military personnel&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS)score of 15, as assessed by the study member at the time of&#xD;
             clinical evaluation following involvement in a mandatory event.&#xD;
&#xD;
          -  Willingness to participate in the study, ability to communicate and comply with the&#xD;
             study protocol and ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GCS score of less than 15&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack W. Tsao, MD, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>U.S. Navy Bureau of Medicine and Surgery (BUMED)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Concussion Restoration Care Center</name>
      <address>
        <city>Camp Leatherneck</city>
        <country>Afghanistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Afghanistan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United States Department of Defense</investigator_affiliation>
    <investigator_full_name>jack tsao</investigator_full_name>
    <investigator_title>Director, TBI Programs</investigator_title>
  </responsible_party>
  <keyword>Concussion</keyword>
  <keyword>Mild traumatic brain injury</keyword>
  <keyword>DANA</keyword>
  <keyword>MACE</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/NCT01728129
org study id: M-10228
nct id: NCT01728129
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE
      cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive
      for detecting impaired cognitive performance than the MACE cognitive score in the setting of
      a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary
      purpose of this study is to examine a serial performance on the DANA Rapid exam in those
      subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam
      will show improvements in performance during the recovery period after concussion.
In Operations Iraqi Freedom and Enduring Freedom (OIF/OEF), over 60% of combat casualties
      have been the result of explosive blasts, and many of these critical injuries involve trauma
      to the head. As a result, traumatic brain injury (TBI) has been deemed a "signature wound" of
      OIF and OEF. The symptoms of head injuries, particularly of concussion/mild TBI (mTBI), can
      be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded
      warrior's appropriate medical care. Most first providers in the war theater are medics who
      could benefit from an improved diagnostic test to better identify service members with
      concussion/mTBI. The MACE cognitive test is heavily weighted towards memory, is not 100%
      specific, and does not preclude a diagnosis of concussion being rendered despite a score in
      the normal range. Thus, an objective test of neurocognitive function, such as the DANA Rapid,
      that can be rapidly administered in theater by a combat medic would be highly beneficial to
      accurate clinical diagnosis and timely treatment. The results of the present study will
      provide information on the predictive value of the newly developed DANA handheld computer in
      assisting in the diagnosis of concussion in service members who have been blast exposed. If
      the DANA Rapid exam proves to be equally or more accurate than the MACE in detecting
      cognitive deficits, these tests and the handheld computer will also contribute to improved
      health care for service members by minimizing the time between injury and diagnosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Sensitivity
time frame: 72 hours from initial injury
description: The primary hypothesis is that an abnormal score on the DANA Rapid will positively identify a greater proportion of concussed individuals than an abnormal cognitive score on the MACE would. Conversely, scores within normal range on the DANA Rapid should be able to rule out cognitive deficits more accurately than a normal score on the MACE
measure: Serial Performance
time frame: 72 hours from initial injury
description: The secondary hypothesis of the study is that scores on the DANA Rapid exam will improve over time as the subject recovers from concussion.
arm group label: Concussed
arm group type: Experimental
description: Subjects who are diagnosed with a concussion by a clinician will be assessed with the MACE and DANA Rapid every 24 hours for up to 72 hours post-injury.
arm group label: Non-concussed
arm group type: Active Comparator
description: Subjects will have been exposed to a potentially concussive event but be clinically evaluated and found not to have sustained a concussion. Control subjects from this arm will take both the MACE and DANA Rapid twice: once within 24 hours of potentially concussive event, and again on the day of return to duty.
intervention type: Device
intervention name: DANA Rapid
description: The DANA Rapid is a neurocognitive test self-administered on a small handheld computer. The DANA Rapid subtests measure simple reaction time, procedural reaction time, and reaction time sensitivity.
arm group label: Concussed
arm group label: Non-concussed
intervention type: Other
intervention name: MACE
description: The MACE is currently the only standardized and Department of Defense-designated method for the initial evaluation of suspected concussion in military operational settings. The MACE documents the history of the injury-causing incident; assesses cognitive deficits in orientation, immediate memory, concentration, and delayed recalls; and involves a neurological screening by a clinician.
arm group label: Concussed
arm group label: Non-concussed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jack W. Tsao, MD, DPhil
role: Principal Investigator
affiliation: U.S. Navy Bureau of Medicine and Surgery (BUMED)
facility: 
country: Afghanistan
responsible party type: Principal Investigator
investigator affiliation: United States Department of Defense
investigator full name: jack tsao
investigator title: Director, TBI Programs
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion