- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728142
Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion
October 5, 2017 updated by: jack tsao, Henry M. Jackson Foundation for the Advancement of Military Medicine
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Camp Leatherneck, Afghanistan
- Concussion Restoration Care Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
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Experimental: Concussed
Individuals who have been diagnosed with a concussion by a clinician.
Participants will take both the DANA and ANAM twice at minimum.
|
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.
The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of DANA Brief's improved sensitivity compared to ANAM
Time Frame: within 10 days of injury
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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
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within 10 days of injury
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jack Tsao, MD, DPhil, U.S. Navy Bureau of Medicine and Surgery (BUMED)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
November 13, 2012
First Submitted That Met QC Criteria
November 13, 2012
First Posted (Estimate)
November 16, 2012
Study Record Updates
Last Update Posted (Actual)
October 6, 2017
Last Update Submitted That Met QC Criteria
October 5, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-10244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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