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DANA Compared to MACE in Evaluation of Suspected Acute Concussion

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
jack tsao, Department of Defense
ClinicalTrials.gov Identifier:
NCT01728129
First received: November 8, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Brain Concussion
Traumatic Brain Injury
Device: DANA Rapid
Other: MACE

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • Sensitivity [ Time Frame: 72 hours from initial injury ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Serial Performance [ Time Frame: 72 hours from initial injury ] [ Designated as safety issue: No ]
    The secondary hypothesis of the study is that scores on the DANA Rapid exam will improve over time as the subject recovers from concussion.


Estimated Enrollment: 220
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concussed
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.
Device: DANA Rapid
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.
Other: MACE
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.
Active Comparator: Non-concussed
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.
Device: DANA Rapid
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.
Other: MACE
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728129

Contacts
Contact: Jack W. Tsao, MD, DPhil 703-681-9102 jack.tsao@med.navy.mil

Locations
Afghanistan
Concussion Restoration Care Center Recruiting
Camp Leatherneck, Afghanistan
Contact: Jack W. Tsao, MD, DPhil    703-681-9102    jack.tsao@med.navy.mil   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jack W. Tsao, MD, DPhil U.S. Navy Bureau of Medicine and Surgery (BUMED)
  More Information

No publications provided

Responsible Party: jack tsao, Director, TBI Programs, Department of Defense
ClinicalTrials.gov Identifier: NCT01728129     History of Changes
Other Study ID Numbers: M-10228
Study First Received: November 8, 2012
Last Updated: August 8, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Concussion
Mild traumatic brain injury
DANA
MACE

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on November 20, 2014