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

NCT ID: NCT01728142

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Brain Concussion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

DANA Brief

Intervention Type DEVICE

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.

ANAM

Intervention Type OTHER

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

Concussed

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

Group Type EXPERIMENTAL

DANA Brief

Intervention Type DEVICE

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.

ANAM

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

ANAM

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role lead

Responsible Party

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jack tsao

Director, TBI Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack Tsao, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

U.S. Navy Bureau of Medicine and Surgery (BUMED)

Locations

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Concussion Restoration Care Center

Camp Leatherneck, , Afghanistan

Site Status

Countries

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Afghanistan

Other Identifiers

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M-10244

Identifier Type: -

Identifier Source: org_study_id