MedTrace Logo

DANA Compared to MACE in Evaluation of Suspected Acute Concussion

NCT01728129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Jack W. Tsao, MD, DPhil · U.S. Navy Bureau of Medicine and Surgery (BUMED)

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Afghanistan

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01728129 on ClinicalTrials.gov