The First Diagnostic Tool for Concussion Testing

The biggest problem in sports today—whether at the pee-wee, high school, collegiate or professional level—is the diagnosis, or non-diagnosis, of concussions. The signs and symptoms can be tricky to identify, even for seasoned medical professionals.

With approximately 6 million people a year suffering from a case of mild traumatic brain injury (TBI) that may or may not result in a concussion, the desperate need for an accurate diagnostic tool is obvious. Researchers all over the world are working on a solution, but it’s a Maryland-based company called BrainScope that has taken the lead with its FDA-approved Ahead 300 device.

The Ahead 300 is a portable EEG (electroencephalogram) that provides a rapid, objective assessment of the likelihood of the presence of TBI in patients who present with mild symptoms at the point of care, which could be a field, the emergency room, a park, etc. The goal of the device is to offer clinicians a comprehensive panel of data to assist in the diagnosis of the full spectrum of TBI.

Eight years and three generations in the making, this iteration of the Ahead 300 was approved by the FDA in September 2016 and became commercially available on a limited basis in January 2017.

“This is a first-of-its-kind instrument. We have finally reached the age where there will be objective quantitative measurements made on the mild-TBI patient, and that’s what is most exciting,” Dr. Daniel Hanley, Jr., M.D., and professor of neurological medicine at the Johns Hopkins University School of Medicine told Laboratory Equipment. Hanley was the lead investigator on the latest clinical trial for the Ahead 300, which showed a 97 percent accuracy in ruling out whether a person with a head injury likely had brain bleeding.

Development of the device comes in part from grant support by the National Football League through the GE/NFL Head Health Initiative. BrainScope has also been awarded more than $27 million in research contracts since 2011 by the U.S. Department of Defense for research and development. These contracts helped support the diagnostic tool through more than 20 clinical studies at 55 sites, as well as its evolution and enhancement through the years.

“We’ve learned in the last 15 years, unfortunately, that blasts cause concussions, so the military is very interested in being able to identify who had a serious blast injury and who had no injury at all but was near where the blast went off,” explained Hanley, noting that the device has applications beyond sports. “The military is very interested in triage and who can go back to work and who can’t. It looks like this device has potential in that second area.”

How it works

The Ahead 300 features BrainScope’s proprietary, patent-protected EEG capabilities in combination with algorithms and machine learning to assess the likelihood a patient presenting with mild-TBI symptoms has more than 1 millimeter of bleeding in the brain, which would require immediate evaluation and further testing/intervention. A disposable electrode headset, powered by smartphone technology, records EEG data from five regions of the forehead and feeds the signals back to the handheld device.

For clinicians who have never had a suited diagnostic tool for TBI before, the Ahead 300 answers two very important questions that can facilitate proper decision-making: 1) Is it likely the mildly presenting head-injured patient has a traumatic structural brain injury that would be visible on a CT scan, which is the gold standard used in emergency rooms?; and 2) Is there evidence of something functionally abnormal with the brain after head injury, which could be a concussion?

In addition to these questions, the Ahead 300 also offers two rapid cognitive performance tests, as well as a number of professional society-based concussion assessment tools commonly used in today’s medical landscape. The 5- to 10-minute cognitive performance tests allow doctors to assess patient performance compared with healthy individuals in the same age group, providing an objective metric. The device also includes four objective tests and 16 standard concussion assessment tools, all of which can be customized since there is no national protocol for TBI/concussion diagnosis.

Most recent clinical trial

Johns Hopkins’ Hanley, also the director of the university’s Brain Injury Outcomes program, recently published a study in Academic Emergency Medicine designed to test the accuracy and effectiveness of the Ahead 300 against a CT scan, the current gold standard for TBI/concussion assessment.

Hanley and his research team recruited 720 adults from 11 emergency departments across the nation who presented with a closed head injury. After standard clinical assessment tests by a doctor or nurse to characterize the patient’s symptoms, the Ahead 300 device was used to measure EEG data—essentially tracking and recording brain wave patterns.

For this study, the device was programmed to read approximately 30 specific features of brain electrical activity, which it uses an algorithm to analyze, and how the patient’s pattern of brain activity compared to the same pattern of brain activity considered normal. For example, it looked for how fast or slow information traveled from one side of the brain to the other, or whether electrical activity in both sides of the brain was coordinated or if one side was lagging.

The accuracy of the device was then tested using CT scans from the patients. The presence of any blood within the intracranial cavity was considered a positive finding, indicating brain bleeding.

Initially, researchers sorted the patients tested with Ahead 300 into two categories—“yes,” indicating likely traumatic brain injury with over 1 mm of bleeding, and “no,” for those with likely no bleeding in the brain.

Of the 564 patients without brain bleeding as confirmed by CT scans, 291 were scored on the Ahead 300 as likely not having a brain injury. However, of the 156 patients with confirmed brain bleeding, the Ahead 300 correctly identified 144, or 92 percent.

Given the nearly 50 percent variance in those without brain bleeding, the researchers then created three categories to sort patients—yes, no and maybe. 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 by the Ahead 300—99 percent of those having 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.

The researchers say these predictive capabilities improve on the clinical criteria currently used to assess whether to do a CT scan—known as the New Orleans Criteria and the Canadian Head CT rules—and predicted the absence of brain bleeding more than 70 percent of the time in those people with no more than one symptom of brain injury, such as disorientation, headache or amnesia.

“This work opens up the possibility of diagnosing head injury in a very early and precise way,” Hanley said. “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 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.”

More to test

This specific study only tested the Ahead 300 on adults between the ages of 18 and 85, leaving off a large portion of the younger target audience. But, since EEG is different across the spectrum of ages, the effectiveness of the device on children and teens needs to be tested in a separate pediatric study—which BrainScope is already working on. Hanley said he hopes to collaborate on that study, as well as any overall concussion research going forward.

“The exciting thing is this has applications across mild TBI,” he said. “This is a measurement that could be used in chronic traumatic encephalopathy (CTE) research. The question there is ‘how many miles add up to CTE?’ This would give you some measure of mild concussion with or without brain bleeding.”