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Completed

NCT Number: NCT01728129

DANA Compared to MACE in Evaluation of Suspected Acute Concussion

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concussion Restoration Care Center

Camp Leatherneck, Afghanistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active duty military personnel
  • Glasgow Coma Scale (GCS)score of 15, as assessed by the study member at the time of clinical evaluation following involvement in a mandatory event.
  • Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent

Exclusion criteria

  • GCS score of less than 15

Treatment and study plan

DANA Rapid

Device

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.

MACE

Other

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.

Primary outcomes

  1. Sensitivity

    Time frame: 72 hours from initial injury

    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

Secondary outcomes

  1. Serial Performance

    Time frame: 72 hours from initial injury

    The secondary hypothesis of the study is that scores on the DANA Rapid exam will improve over time as the subject recovers from concussion.

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Tool to the Military Acute Concussion Evaluation (MACE) in the Evaluation of Suspected Acute Concussion

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2012
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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