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

Primary Purpose

Traumatic Brain Injury, Brain Concussion

Status
Completed
Phase
Not Applicable
Locations
Afghanistan
Study Type
Interventional
Intervention
DANA Brief
ANAM
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring DANA, ANAM, Concussion, mild traumatic brain injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Concussion Restoration Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-concussed

Concussed

Arm Description

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.

Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 13, 2012
Last Updated
October 5, 2017
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01728142
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Brain Concussion
Keywords
DANA, ANAM, Concussion, mild traumatic brain injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-concussed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Concussed
Arm Type
Experimental
Arm Description
Individuals who have been diagnosed with a concussion by a clinician. Participants will take both the DANA and ANAM twice at minimum.
Intervention Type
Device
Intervention Name(s)
DANA Brief
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ANAM
Intervention Description
The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
Primary Outcome Measure Information:
Title
Evidence of DANA Brief's improved sensitivity compared to ANAM
Description
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
Time Frame
within 10 days of injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Tsao, MD, DPhil
Organizational Affiliation
U.S. Navy Bureau of Medicine and Surgery (BUMED)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concussion Restoration Care Center
City
Camp Leatherneck
Country
Afghanistan

12. IPD Sharing Statement

Learn more about this trial

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

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