<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/NCT01728142</url>
  </required_header>
  <id_info>
    <org_study_id>M-10244</org_study_id>
    <nct_id>NCT01728142</nct_id>
  </id_info>
  <brief_title>Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion</brief_title>
  <official_title>Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Brief Exam to the Automated Neuropsychological Assessment Metrics (ANAM) Battery in the Evaluation of Cognitive Changes During Concussion Recovery</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 Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,&#xD;
      portable, and &quot;field-hardened&quot; NeuroCognitive Assessment Tool. The purpose of this study is&#xD;
      to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological&#xD;
      Assessment Metrics (ANAM) battery currently used by the military after concussion. The&#xD;
      primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued&#xD;
      impaired cognitive performance than the ANAM during recovery after a concussion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among active duty military personnel deployed to combat theaters, blast injury is a leading&#xD;
      cause of traumatic brain injury (TBI). Service members with TBI can experience notable&#xD;
      neurological impairments-e.g., attention disturbances, memory and language deficits, and&#xD;
      delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion&#xD;
      with no overt physical symptoms. Thus, there is a critical need to have an efficient means to&#xD;
      determine the incidence of cognitive deficits in service members exposed to or injured by&#xD;
      blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which&#xD;
      neurocognitive test more reliably and accurately detects cognitive impairments during the&#xD;
      recovery period from a concussion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of DANA Brief's improved sensitivity compared to ANAM</measure>
    <time_frame>within 10 days of injury</time_frame>
    <description>Outcome will be confirmed by the ability of the DANA Brief to detect statistically significant differences in cognitive performance between concussed and non-concussed groups even after the ANAM has indicated full recovery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Brain Concussion</condition>
  <arm_group>
    <arm_group_label>Non-concussed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concussed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DANA Brief</intervention_name>
    <description>The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.</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>ANAM</intervention_name>
    <description>The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.</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 U.S. military service members&#xD;
&#xD;
          -  Clinical diagnosis of concussion/mild traumatic brain injury (mTBI) (as defined by the&#xD;
             American Congress of Rehabilitation, 1993, and DoD), made by the treating clinician&#xD;
             based on clinical history, examination and/or clinical imaging performed as part of&#xD;
             standard of care. This includes subjects with concussion from any mechanism&#xD;
             (blast-related, blunt trauma etc.)--for concussed subjects only&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) score of 15 as assessed by the consenting research staff--for&#xD;
             concussed subjects only&#xD;
&#xD;
          -  Concussive event that occurred within 72 hours of injury (to exclude service members&#xD;
             presenting due to lingering effects of a previous injury)--for concussed subjects only&#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;
          -  Have a history of other mTBI within 90 days, moderate brain injury within the past 3&#xD;
             years, or any lifetime history of severe brain injury&#xD;
&#xD;
          -  History of a documented diagnosis of post traumatic stress disorder (PTSD) or of&#xD;
             treatment for PTSD&#xD;
&#xD;
          -  Taking psychoactive medications, opioids, or other significant sedating medication&#xD;
&#xD;
          -  Individuals with severe psychiatric disorders requiring continuing medication or&#xD;
             recent treatment for an alcohol or drug dependency&#xD;
&#xD;
          -  Report a pain level of 8 or greater on the 10-point Likert scale of 1 to 10 (e.g., 8,&#xD;
             9 or 10).&#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 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 13, 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>DANA</keyword>
  <keyword>ANAM</keyword>
  <keyword>Concussion</keyword>
  <keyword>mild traumatic brain injury</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/NCT01728142
org study id: M-10244
nct id: NCT01728142
lead sponsor: 
collaborator: 
has dmc: No
The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,
      portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is
      to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological
      Assessment Metrics (ANAM) battery currently used by the military after concussion. The
      primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued
      impaired cognitive performance than the ANAM during recovery after a concussion.
Among active duty military personnel deployed to combat theaters, blast injury is a leading
      cause of traumatic brain injury (TBI). Service members with TBI can experience notable
      neurological impairments-e.g., attention disturbances, memory and language deficits, and
      delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion
      with no overt physical symptoms. Thus, there is a critical need to have an efficient means to
      determine the incidence of cognitive deficits in service members exposed to or injured by
      blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which
      neurocognitive test more reliably and accurately detects cognitive impairments during the
      recovery period from a concussion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evidence of DANA Brief's improved sensitivity compared to ANAM
time frame: within 10 days of injury
description: Outcome will be confirmed by the ability of the DANA Brief to detect statistically significant differences in cognitive performance between concussed and non-concussed groups even after the ANAM has indicated full recovery
arm group label: Non-concussed
arm group type: Active Comparator
description: Control group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum.
arm group label: Concussed
arm group type: Experimental
description: Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.
intervention type: Device
intervention name: DANA Brief
description: The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.
arm group label: Concussed
arm group label: Non-concussed
intervention type: Other
intervention name: ANAM
description: The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
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 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