Clinical trial NCT01728142: Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Brain Concussion
Keywords: DANA
ANAM
Concussion
mild traumatic brain injury
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2012-11-16
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evidence of DANA Brief's improved sensitivity compared to ANAM
timeFrame: within 10 days of injury
Secondary outcomes:
Other outcomes:
Locations:
city: Camp Leatherneck
country: Afghanistan
facility: Concussion Restoration Care Center
Study officials:
affiliation: U.S. Navy Bureau of Medicine and Surgery (BUMED)
name: Jack Tsao, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: