Skip to main content
Clinical Trials/NCT01728142
NCT01728142CompletedNot Applicable

Comparison of the Defense Automated Neurobehavioral Assessment (DANA) Brief Exam to the Automated Neuropsychological Assessment Metrics (ANAM) Battery in the Evaluation of Cognitive Changes During Concussion Recovery

Henry M. Jackson Foundation for the Advancement of Military Medicine1 site in 1 country118 target enrollmentStarted: January 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
118
Locations
1
Primary Endpoint
Evidence of DANA Brief's improved sensitivity compared to ANAM

Study Overview

Brief Summary

The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable, portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological Assessment Metrics (ANAM) battery currently used by the military after concussion. The primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued impaired cognitive performance than the ANAM during recovery after a concussion.

Detailed Description

Among active duty military personnel deployed to combat theaters, blast injury is a leading cause of traumatic brain injury (TBI). Service members with TBI can experience notable neurological impairments-e.g., attention disturbances, memory and language deficits, and delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion with no overt physical symptoms. Thus, there is a critical need to have an efficient means to determine the incidence of cognitive deficits in service members exposed to or injured by blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which neurocognitive test more reliably and accurately detects cognitive impairments during the recovery period from a concussion.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Active-duty U.S. military service members
  • Clinical diagnosis of concussion/mild traumatic brain injury (mTBI) (as defined by the American Congress of Rehabilitation, 1993, and DoD), made by the treating clinician based on clinical history, examination and/or clinical imaging performed as part of standard of care. This includes subjects with concussion from any mechanism (blast-related, blunt trauma etc.)--for concussed subjects only
  • Glasgow Coma Scale (GCS) score of 15 as assessed by the consenting research staff--for concussed subjects only
  • Concussive event that occurred within 72 hours of injury (to exclude service members presenting due to lingering effects of a previous injury)--for concussed subjects only
  • Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent.

Exclusion Criteria

  • Have a history of other mTBI within 90 days, moderate brain injury within the past 3 years, or any lifetime history of severe brain injury
  • History of a documented diagnosis of post traumatic stress disorder (PTSD) or of treatment for PTSD
  • Taking psychoactive medications, opioids, or other significant sedating medication
  • Individuals with severe psychiatric disorders requiring continuing medication or recent treatment for an alcohol or drug dependency
  • Report a pain level of 8 or greater on the 10-point Likert scale of 1 to 10 (e.g., 8, 9 or 10).

Arms & Interventions

Non-concussed

Active Comparator

Control group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum.

Intervention: DANA Brief (Device)

Non-concussed

Active Comparator

Control group; individuals assigned to this group will be either healthy volunteers or individuals sustaining an injury that does not involve concussion. Participants will take both the ANAM and DANA Brief twice at minimum.

Intervention: ANAM (Other)

Concussed

Experimental

Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.

Intervention: DANA Brief (Device)

Concussed

Experimental

Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.

Intervention: ANAM (Other)

Outcomes

Primary Outcomes

Evidence of DANA Brief's improved sensitivity compared to ANAM

Time Frame: within 10 days of injury

Outcome will be confirmed by the ability of the DANA Brief to detect statistically significant differences in cognitive performance between concussed and non-concussed groups even after the ANAM has indicated full recovery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

jack tsao

Director, TBI Programs

United States Department of Defense

Study Sites (1)

Loading locations...

Similar Trials