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

Not Applicable

Completed

• Conditions: Brain Concussion; Traumatic Brain Injury
• Interventions: Device: DANA Brief; Other: ANAM

• Registration Number: NCT01728142
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

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 Timeline

• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-16
• Study Start: 2013-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-concussed	DANA Brief	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.
Non-concussed	ANAM	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.
Concussed	DANA Brief	Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.
Concussed	ANAM	Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.

Primary Outcome Measures

Name	Time	Method
Evidence of DANA Brief's improved sensitivity compared to ANAM	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

Trial Locations

Locations (1)

Concussion Restoration Care Center; 🇦🇫 Camp Leatherneck, Afghanistan