DANA Compared to MACE in Evaluation of Suspected Acute Concussion

NCT01728129 | Completed

• 1 other identifier: M-10228
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Brain Concussion; Traumatic Brain Injury

Keywords

Concussion; Mild traumatic brain injury; DANA; MACE

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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

  72 hours from initial injury

Secondary Outcomes (1)

• Serial Performance

  72 hours from initial injury

Study Arms (2)

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.

Device: DANA Rapid; Other: MACE

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.

Device: DANA Rapid; Other: MACE

Interventions

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.

Concussed; Non-concussed

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.

Concussed; Non-concussed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• GCS score of less than 15

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Concussion Restoration Care Center

Camp Leatherneck, Afghanistan

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

omega-Chloroacetophenone

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals

Study Officials

• Jack W. Tsao, MD, DPhil

  U.S. Navy Bureau of Medicine and Surgery (BUMED)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, TBI Programs

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

AF (1)