A clinical trial conducted at 11 emergency departments nationwide has demonstrated that a handheld electroencephalography (EEG) device can rapidly and with 97 percent accuracy determine whether someone with a head injury is likely to have brain bleeding and needs further evaluation or treatment.
The Ahead 300 device, developed by BrainScope Company, measures electrical activity in the brain and leverages a disposable sensor headset. The Food and Drug Administration cleared the device for clinical use last September.
Results of the clinical trial, published online in the peer-reviewed journal Academic Emergency Medicine, show that the device can help with clinical decision support and triage of patients while potentially reducing the need for CT scans, particularly as an adjunct to acute traumatic brain injury assessment where imaging may be unavailable.
“It’s low cost, portable and gives you an objective measure of likelihood to have bleeding in the brain,” says Daniel Hanley, MD, lead author of the study and Jeffrey and Harriet Legum Professor of Acute Care Neurological Medicine and director of the Brain Injury Outcomes Program at the Johns Hopkins University School of Medicine.
“I think it’s going to objectify head injury in a way that it hasn’t been before,” adds Hanley, who contends that the Ahead 300 device is “the first of its kind and is likely to change the landscape of traumatic brain injury.”
Hanley believes that the handheld EEG device lends itself to use beyond emergency departments for use in urgent care and concussion clinics, as well as sports and military environments. The study was funded in part by the U.S. Army. BrainScope’s website states that the Ahead 300 was developed in partnership with the Department of Defense through six research contracts.
According to the Centers for Disease Control and Prevention, about 2.5 million Americans annually go to emergency departments with suspected head injuries. But, Hanley observes that the vast majority of those who present to the ED with mild symptoms following head injury receive a CT scan, although studies show that more than 90 percent of those scans show that patients don’t have an intracranial brain injury.
“Out of an abundance of caution, you can always scan more people than you need to, which is what’s going on now,” says Hanley, who notes that these CT scans result in needless radiation exposure and cost about $1,200 per scan.
At the same time, Hanley contends that the Ahead 300 device is not meant to replace CT scans for patients with mild head injuries, but instead provides clinicians with additional information to facilitate routine clinical decision-making. “It may be that we do fewer images” as a result of this study, he adds. “That will save money and make care more efficient.”
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