跳至主要内容
临床试验/NCT01728129
NCT01728129已完成不适用

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

Henry M. Jackson Foundation for the Advancement of Military Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • GCS score of less than 15

研究组 & 干预措施

Concussed

Experimental

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.

干预措施: DANA Rapid (Device)

Concussed

Experimental

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.

干预措施: MACE (Other)

Non-concussed

Active Comparator

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.

干预措施: DANA Rapid (Device)

Non-concussed

Active Comparator

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.

干预措施: MACE (Other)

结局指标

主要结局

Sensitivity

时间窗: 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

次要结局

  • Serial Performance(72 hours from initial injury)

研究者

发起方
Henry M. Jackson Foundation for the Advancement of Military Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

jack tsao

Director, TBI Programs

United States Department of Defense

研究点 (1)

Loading locations...

相似试验