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

NCT01728142 | Completed

• 1 other identifier: M-10244
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Brain Concussion

Keywords

DANA; ANAM; Concussion; mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Non-concussed

ACTIVE COMPARATOR

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; Other: ANAM

Concussed

EXPERIMENTAL

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; Other: ANAM

Interventions

DANA Brief 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.

Concussed; Non-concussed

ANAM OTHER

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

Concussed; Non-concussed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Concussion Restoration Care Center

Camp Leatherneck, Afghanistan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Jack Tsao, MD, DPhil

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, TBI Programs

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

AF (1)