Device to Measure Brain's Electrical Activity After Injury Receives FDA Clearance
When describing a new device designed to measure the brain's electrical activity after injury, Col. Dallas Hack cut through all the details to get straight to the point of why the Army needed another tool in its arsenal.
"It addresses the 'gap area' of non-invasive tests for brain injury," said Hack.
Hack, the Brain Health/Fitness Research Program coordinator for the U.S. Army Medical Research and Materiel Command, explained that when Soldiers fall in training or endure a blast on the battlefield, their injuries are not always visible. However, clinicians have historically had few objective ways to test for brain injury, especially non-invasive testing that provides objective results.
The Ahead 100, which received clearance from the U.S. Food and Drug Administration in November 2014, is a headband-shaped device that measures a patient's electroencephalogram signals, or brain electrical activity. A clinician interprets the testing and results.
"The original concept was simple," said Michael Singer, the president and CEO of BrainScope Company, Inc., the neurotechnology firm that created the Ahead 100 via funding from the U.S. Department of Defense. "We wanted to put something into your hand that allowed you to use an EEG, and use it rapidly."
According to the Centers for Disease Control and Prevention, TBI-related emergency room visits by men have jumped by more than 50 percent in the past 10 years alone. Visits by women hover near the same mark throughout the same time period. The Ahead 100 is intended for use within 24 hours on patients who have sustained a closed-head injury and show signs of traumatic brain injury.
Hack added, "Long-term benefits include the expansion to milder concussion indications, which will be valuable to a clinician in recommending a treatment plan."