A clinical trial led by director of the of the Brain Injury Outcomes Program at Johns Hopkins and the Legum Professor of Neurological Medicine, Daniel Hanley Jr., M.D., reveals that a device that was approved by the U.S. Food and Drug Administration in 2016.
The trial was conducted at 11 hospitals among adults, the handheld EEG device can quickly rule out a brain bleed, with a 97 percent accuracy rating. The researchers not that further studies are required for treatment and evaluation.
An estimated 2.5 million Americans visit the emergency room each year with suspected head injuries, according the Centers for Disease Control and Prevention (CDC). Most people undergo a CT scan and in 90 percent of the cases, the results reveal no structural brain injury. Not only does this create unnecessary radiation exposure, but also drives up medical costs by nearly $1,200 per scan.
The handheld EEG can measure brain activity by converting electrical activity of neurons into rhythms, which are called brain waves. The device utilizes algorithm to detect a likely brain bleed, making it suitable for patient triage, along with helping with clinical decision-making and reducing the need for a CT scan.
“Before our study, there were no objective, quantitative measures of mild head injury other than imaging,” says Dr. Daniel Hanley Jr. “This work opens up the possibility of diagnosing head injury in a very early and precise way.”
Dr. Hanley says that the technology should not take the place of the CT scan in patients with suspected mild head injury. However, it can provide clinicians with more data to enable routine clinical decision-making.
The research team only observed adults, so further studies will be required to test the effectiveness of the handheld EEG in teens and children, with traumatic injuries.
The study focused on the effectiveness of the AHEAD 300 device, which was created by Maryland-based BrainScope Company Inc. A limited number of the devices are currently available via a center of excellence program. Since the development of the device eight years ago, it has been utilized in several human trials, as well as previous versions of the device. The device is designed to assess the probability that an individual has “more than 1 milliliter of bleeding” within the brain and immediate clinical evaluation is required.
The course of the study ran from February through December 2015. A total of 720 participants between the ages of 18 and 85 and 60 percent men from 11 Emergency Departments nationwide, volunteered for the study. The participants presented at the Emergency Department with a suspected closed head injury or where the skull was intact. When the patient was admitted into the Emergency Department, a physician performed the standard-of-care clinical assessment for head injuries utilized at the specific site. A technician trained to administer the Concussion Symptom Inventory and Standardized Assessment of Concussion followed up after the clinician, by administering these to characterize the symptoms the patient was experiencing. The trained technician then utilized the AHEAD 300 device to measure the electroencephalogram or EEG data – tracking and recording brain activity, while the patient relaxed in the supine position for 5-10 minutes. The device comes with a single-use headset that is capable of recording EEG data from five separate regions of the forehead and feeding the signals back to the handheld device in real-time. Prior to testing, the technician enters demographic and clinical data into the device, including the Glasgow Coma Scale score, a scoring system utilized to record the conscious state, and age.
The findings revealed that out of the 720 participants that volunteered for the study, 564 did not have traumatic brain injuries. These results were determined by judged and independently measured CT scans.
To test the accuracy of the AHEAD 300 device, the researchers utilized the results of the participants’ CT scans and data from medical records after 30 days of initial testing, as well as data collected from the follow up calls made to each participant by the researchers. If blood was present within the intracranial cavity, the findings were considered positive.
The study was published online on March 31, 2017 in Academic Emergency Medicine.