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.

In a report on their clinical trial, described online March 31 in the journal 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.

“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.

On the basis of AHEAD 300 classification, the researchers sorted patients into “yes” or “no” categories, indicating likely traumatic brain injury with over 1 millimeter of bleeding or not. Of 564 patients without brain bleeding, as confirmed with CT scans, 291 patients were scored on the AHEAD 300 as likely not having a brain injury. Of the 156 patients with confirmed brain bleeding, 144, or 92 percent, were assessed as likely to have an injury by the AHEAD 300 classification. Of those confirmed with brain bleeding via CT scan, 12 participants, or 8 percent, had some intracranial bleeding, and five participants, or 3 percent, had more than 1 milliliter of blood in the brain.

Because many of the incorrect yes/no classifications don’t contain information about how close a patient is to the cutoff, the researchers then created three categories to sort patients by — “yes,” “no” and “maybe” — to see if this boosted the accuracy of the device. The maybe category included a small number of patients with greater–than–usual abnormal EEG activity that was not statistically high enough to be definitely positive. When the results were recalculated on the three–tier system, the sensitivity of detecting someone with a traumatic brain injury increased to 97 percent, with 152 of 156 traumatic head injuries detected, and 99 percent of those had more than or equal to 1 milliliter of bleeding in the brain. None of the four false negatives required surgery, returned to the hospital due to their injury or needed additional brain imaging.