DANA Compared to MACE in Evaluation of Suspected Acute Concussion
Condition: Brain Concussion; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): DANA Rapid; MACE
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Concussion; Mild traumatic brain injury; DANA; MACE