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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728142
• Other study ID #: M-10244
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: October 5, 2017
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2017
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury

Intervention

Device:
• DANA Brief
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.

Other:
• ANAM
The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.

Locations

Country	Name	City	State
Afghanistan	Concussion Restoration Care Center	Camp Leatherneck

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

Afghanistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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