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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
jack tsao, Department of Defense
ClinicalTrials.gov Identifier:
NCT01728142
First received: November 13, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Brain Concussion
Device: DANA Brief
Other: ANAM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • Evidence of DANA Brief's improved sensitivity compared to ANAM [ Time Frame: within 10 days of injury ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 118
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-concussed
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
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.
Experimental: Concussed
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
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.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728142

Contacts
Contact: Jack Tsao, MD, DPhil 703-681-9102 jack.tsao@med.navy.mil

Locations
Afghanistan
Concussion Restoration Care Center Recruiting
Camp Leatherneck, Afghanistan
Contact: Jack W. Tsao, MD, DPhil    703-681-9102    jack.tsao@med.navy.mil   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jack Tsao, MD, DPhil U.S. Navy Bureau of Medicine and Surgery (BUMED)
  More Information

No publications provided

Responsible Party: jack tsao, Director, TBI Programs, Department of Defense
ClinicalTrials.gov Identifier: NCT01728142     History of Changes
Other Study ID Numbers: M-10244
Study First Received: November 13, 2012
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
DANA
ANAM
Concussion
mild traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on October 01, 2014