April 5, 2017 -- Johns Hopkins University -- In a clinical trial conducted among adults in 11 hospitals, researchers have shown that a hand-held EEG device approved in 2016 by the U.S. Food and Drug Administration that is commercially available can quickly and with 97 percent accuracy rule out whether a person with a head injury likely has brain bleeding and needs further evaluation and treatment.

According to the Centers for Disease Control and Prevention, about 2.5 million Americans each year show up to the emergency room with suspected head injuries. Most of these people receive a CT scan, and more than 90 percent of the scans show no structural brain injury, creating needless radiation exposure and medical costs estimated at about $1,200 per scan.

In a report on their clinical trial, described online March 31 in Academic Emergency Medicine, the researchers say the new device — which measures electrical activity in the brain and then uses an algorithm to decide if a patient is likely to have brain bleeding — can help with clinical decision-making and triage of patients, and could reduce the need for CT scans.
“Before our study, there were no objective, quantitative measures of mild head injury other than imaging,” says lead investigator Daniel Hanley Jr., M.D., the Legum Professor of Neurological Medicine and director of the Brain Injury Outcomes Program at the Johns Hopkins University School of Medicine. “This work opens up the possibility of diagnosing head injury in a very early and precise way.

“This technology is not meant to replace the CT scan in patients with mild head injury, but it provides the clinician with additional information to facilitate routine clinical decision-making,” says Hanley. “If someone with a mild head injury was evaluated on the sports or battlefield, then this test could assist in the decision of whether or not he or she needs rapid transport to the hospital. Alternatively, if there is an accident with many people injured, medical personnel could use the device to triage which patients would need to have CT scans and who should go first. Those showing a ‘positive’ for brain injury would go first.”

The study only looked at adults and didn’t assess how well the device could predict traumatic brain injuries in children or teens.

The study, Hanley says, was designed to test the accuracy and effectiveness of AHEAD 300, a device developed by BrainScope Company Inc. of Bethesda, Maryland, that is now available to a limited audience through a centers of excellence program. Throughout its eight years of development, the company has tested this and prior generations of the device in multiple human trials. The point of the device is to assess the likelihood that a patient has more than 1 milliliter of bleeding in the brain and needs immediate evaluation by medical personnel.

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