The AHEAD 300 hand-held EEG device, approved by the U.S. Food and Drug Administration in 2016, was the subject of a clinical trial conducted among adults in 11 hospitals. Researchers found that the device, developed by BrainScope Company Inc., of Bethesda Maryland, can quickly rule out whether a person with a head injury is likely to have brain bleeding requiring further evaluation and treatment. The results have an accuracy rate of 97 percent.
Approximately 2.5 million people arrive at the emergency room with a suspected head injury each year in the U.S. according to the Centers for Disease Control and Prevention. Most of these patients receive a CT scan and 90 percent of the scans reveal no structural brain injury. This not only creates needless exposure to radiation; each scan comes with an average price tag of $1200.
The new device, which measures electrical activity in the brain and then uses an algorithm to determine if a patient has brain bleeding, can be a useful decision making tool, reducing the need for CT scans, as described on March 31 in a report published in Academic Emergency Medicine.
“Before our study, there were no objective, quantitative measures of mild head injury other that imaging,” explained Daniel Hanley Jr., M.D. the Legum Professor of Neurologic Medicine and the director of the Brain Injury Outcomes Program at the Johns Hopkins University School of Medicine, the study’s lead investigator. “This work opens up the possibility of diagnosing head injury in a very early and precise way.”
Hanley continued by saying, “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. If someone with a mild head injury was evaluated on the sports or battlefield, then this test could assist in the decision 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 would go first.”
The study focused on adults only and did not assess how well the device could predict traumatic injury in youths.
Per Dr. Hanley, the study was used to test the accuracy and effectiveness of the AHEAD 300 which is available through a centers of excellence program in limited number. The point of the device is determining the likelihood that a patient has bleeding in the brain exceeding one millimeter and requires immediate medical evaluation.
The Structure of the Study
Researchers began by recruiting 720 adults, who arrived at 11 Emergency Department across the country between February and December 2015, with a non-penetrating head injury. The recruited patients were between 18 and 85 years of age. Standard clinical assessments were performed by each of the physicians at their site. A trained technician followed, with the administration of Standardized Assessment of Concussion and the Concussion Symptom Inventory, to characterize the symptoms of each patient. They then used the AHEAD 300 device to measure electroencephalogram (EEG) data from patients while they reclined quietly for five to ten minutes. A disposable headset records EEG data from five areas on the forehead and feeds the signals back to the AHEAD 300 device in real time. Certain clinical and demographic information was entered into the device by the technician including the patients age, the Glasgow Coma Scale score, which determines a person’s level of consciousness, as well as any loss of consciousness resulting from the injury.
The AHEAD 300 was programmed to use an algorithm to analyze approximately 30 specific features of electrical activity in the brain and compares this brain activity to a pattern which is considered normal. The speed in which information traveled from one side of the brain to another, or if one side of the brains electrical activity was coordinated with the other side or if one was lagging, are examples.
CT scans from the participants were used to determine the accuracy of the device. Any blood that was present within the cranial cavity indicated brain bleeding. The researchers followed up with phone calls to the patients after 72 to 96 hours as well as examining medical records after 30 days to confirm the accuracy of each participant’s injury status.
The Results
Based upon the AHEAD 300 classification, the patients were divided into three categories of “yes” “no” or “maybe” as indicators of bleeding more than one millimeter or not. Of 564 patients without brain bleeding, as confirmed by CT scans, 291 patients were scored with the AHEAD 300 as not likely to have a brain injury. Of the 156 confirmed with brain bleeding, 144, or 92 percent, were determined as likely to have an injury by the AHEAD 300 classification. Participants confirmed with brain bleeding by the CT scan revealed 12 individuals, or 8 percent, had some intercranial bleeding, and five individuals, or 3 percent, had more than one millimeter of blood in the brain.
When the results were recalculated into the three-tier system of “yes” “no” or “maybe,” the “maybe” category included a small number of patients with greater than usual EEG activity that was not statistically high enough to be a definite positive. As a result, the sensitivity of detecting someone with a traumatic brain injury increased to 97 percent.
As with a typical EEG, there are no inherent risks or side effects from the AHEAD 300 device.
Vititoe Law Group is a personal injury law firm specializing in traumatic brain injury as one area of practice. For a free initial consultation call 818-851-1886
