Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Traumatic Brain Injury, Brain Concussion

Intervention / Treatment
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* Device: DANA Brief
* Other: ANAM


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-concussed<br>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. | Device: DANA Brief<br>* The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.<br>Other: ANAM<br>* The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.<br>|
| Experimental: Concussed<br>Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum. | Device: DANA Brief<br>* The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.<br>Other: ANAM<br>* The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of DANA Brief's improved sensitivity compared to ANAM | 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 | within 10 days of injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DANA, ANAM, Concussion, mild traumatic brain injury