A new handheld EEG (electroencephalogram) device can quickly and with 97 percent accuracy rule out whether a person with a traumatic brain injury (TBI) likely has brain bleeding and needs further evaluation and treatment, according to a new clinical trial testing the efficacy of the new EEG tool which was approved in 2016 by the U.S. Food and Drug Administration.
About 2.5 million Americans each year go to the hospital emergency room with suspected head injuries, according to the Centers for Disease Control and Prevention. A majority of these patients are given a CT scan, and more than 90 percent of these scans show no structural brain injury, creating needless radiation exposure and medical costs estimated at about $1,200 per scan.
The new device, known as AHEAD 300, measures electrical activity in the brain and then uses an algorithm to decide if a patient is likely to have brain bleeding. In a report in the journal Academic Emergency Medicine, the researchers say the tool could potentially help with clinical decision-making and assessment 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,” said 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,” Hanley said.
“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 focused on adults and so it is unknown whether the device can predict traumatic brain injuries in children or teens.
The study involved 720 adults who came to 11 emergency departments (ED) across the nation between February and December 2015 with a closed head injury, meaning the skull was intact. Participants were between 18 and 85 years old, and 60 percent were men.
Upon entry to the ED, each patient underwent standard clinical assessments for head injuries. A trained technician then used the AHEAD 300 device to measure electroencephalogram (EEG) data — essentially tracking and recording brain wave patterns — from patients while they reclined quietly for five to 10 minutes.
The device is designed to read approximately 30 specific features of brain electrical activity, which it uses an algorithm to analyze, and to assess how the patient’s pattern of brain activity compares to the same pattern of brain activity considered normal.
For example, it measures how fast or slow information travels from one side of the brain to the other, or whether electrical activity in both sides of the brain is coordinated or if one side is lagging.
The accuracy of the device was tested using CT scans from the participants. The presence of any blood within the intracranial cavity was considered a positive finding, indicating brain bleeding.
After 72 to 96 hours, the researchers followed up with phone calls to the patients and/or looked at medical records after 30 days to further confirm the accuracy of each participant’s injury status.
Of the 720 patients, 564 turned out not to have traumatic brain injuries, and 156 did have them, as determined by independently measured and judged CT scan assessments.
Source: Johns Hopkins Medicine