Mobile App to Diagnose Head Injuries Scores FDA Clearance
"This is what's important right now," said Lt. Col. Chessley Atchison, as he handled the various medical prototypes placed openly around his office, removed from their hard, black plastic cases. "And once we get it right, we're going to put it fairly far forward in the field."
Atchison, the program manager for the Technology Enabled Capability Demonstration: Brain in Combat portfolio of the Combat Casualty Care Research Program, is referring to the new Defense Automated Neurobehavioral Assessment, a tool that recently received U.S. Food and Drug Administration clearance.
"It's like a brain thermometer," said Atchison.
DANA is a mobile phone-based application, or app, designed to help medical providers identify cases of traumatic brain injury in almost any setting, which may help clinicians diagnose a patient in as little as five minutes.
The app will operate much like a video game. Service Members will perform a baseline series of on-screen exercises during which both their speed and accuracy will be recorded. Service Members who may have had a serious head injury will then participate in a series of both cognitive efficiency tests and self-administered questionnaires. Afterward, a clinician will review the results, comparing them to the results of the baseline exercises. The combination of the app's cognitive and psychological components allows for insight into the prevalence of symptoms related to both TBI and post-traumatic stress disorder.
"In essence, measuring reaction time is like taking the temperature of the brain," said Corinna Lathan, founder and CEO of AnthroTronix, Inc., the Maryland-based research and development company that created the DANA. "It's a vital part of the data that any health professional needs to evaluate his patient."
According to the DANA research team, some of the factors that may affect reaction time include concussion, dementia, post-traumatic stress, depression and fatigue, among others.
Once fully validated for battlefield use, military officials said the product may be used to assist medical providers. In addition, DANA may be used to help assess fitness for duty and possible triage needs when warranted. In these instances, the mobility of the DANA'its accessibility in a variety of settings and locations'augments its functionality. The software can run on a variety of platforms and is currently being tested on tablet devices as well.
DANA received development funding, in part, through a grant from the Rapid Innovation Fund, a federal support mechanism for small businesses. Developing innovative tools such as DANA is a priority for the military, especially as experts' understanding of TBI expands. In 2013, more than 27,000 cases of traumatic brain injury were diagnosed across all four main service branches stationed around the globe, according to the Department of Defense. That number is almost triple the number of cases diagnosed in 2000, when the DoD first began recording TBI statistics.