Friday evening The Lancet Neurology published a new study concluding that a handheld portable device and blood test could help detect real-time brain injuries, even if a CT scan does not. Findings from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study suggest that technology might be able to fill a significant gap in emergency departments, sport fields and battle fields. Within as little as 15 minutes, patients who might have otherwise gone undiagnosed can be identified.
Although concussions and brain injuries are still greatly misunderstood, each year 4.8 million people in the U.S. visit the emergency room to be evaluated for a brain injury, and 82% of those have a head CT scan performed to test for TBI. Further, according to the Defense and Veterans Brain Injury Center, more than 380,000 military members have sustained TBIs over the past 20 years. But the most troubling part of brain injury statistics is that previous research found half of concussions go undetected and undiagnosed. That’s millions a year.
One of the main reasons is that current tools are not capable of detecting all brain injuries. Thus, even for those who do suspect an injury, cognitive and neurological questionnaires and CT scans simply cannot do the job well enough. And in situations like those following an accident or during combat, missing a diagnosis or waiting days for one could have significant consequences. But new blood-based biomarkers are emerging as an important tool to detect TBI.
Collaboration, Not Competition
Unfortunately, the field of neuroscience – and brain injuries in particular – have gotten a lot of attention over the last decade, but with much of the literature and many claims going unsubstantiated, or unable to be validated and replicated. But the authors of this article claim that the large, prospective cohort design and dynamic partnerships of TRACK-TBI are what make these results different, important, and exciting.
The TRACK-TBI study is one of the largest concussion studies of its kind, having evolved from the largest and most comprehensive natural history study of TBI ever conducted in the U.S. Led by the University of California San Francisco (UCSF), funding for the study comes from the National Institute of Neurological Disorders and Stroke (NINDS) and the U.S. Department of Defense (DOD), through U.S. Army Medical Research and Materiel Command (USAMRMC) and U.S. Army Medical Materiel Development Activity (USAMMDA), as well as funding from philanthropic and private partners, like Abbott.
According to Geoffrey T. Manley, M.D., Ph.D., the principal investigator of TRACK-TBI and a neurosurgeon and professor of neurosurgery at UCSF, “We all have a unified, common goal to advance technologies that provide objective information about what’s happening to the brain. The brain and brain injury are extremely complex. So, this work and the results are really about the power of partnership.”
In 2014, the DOD and Abbott partnered to begin working on developing a portable blood test that helps assess concussions right at a person’s side. And the military continues to use Abbott’s current i-STAT system, a handheld blood analyzer that carries out a range of clinical tests. Building on this, with its involvement in TRACK-TBI, Abbott now has more than 120 scientists devoted to researching and developing the concussion assessment test for the next generation of i-STAT™ Alinity™ system.
A critical part of the TRACK-TBI research initiative is to evaluate the effectiveness of blood-based biomarkers to detect brain injury.Consequently, the goal of this collaboration is to have a blood test based on robust, proven data that can easily be utilized in the military, on the field, and in hospitals around the world. To do this, Abbott provided its newest blood test to TRACK-TBI for analysis, while being blinded throughout the study to which samples represented which subjects.
The study results looked at the new handheld blood test, which specifically measures two types of proteins – GFAP and UCH-L1 – that are released from the brain and into the blood when the brain is injured. Or, as Beth McQuiston, M.D., R.D., neurologist and medical director in diagnostics at Abbott puts it, “We have blood tests used in the hospital to detect injury throughout the body. For example, your heart, kidney and liver. Yet, we don’t have a blood test to detect injury in the brain. This research shows that a blood test has the potential to help doctors evaluate and treat patients suspected of brain injury quickly and accurately to get them back to better health. Our blood test in development could be the first point-of-care blood test for assessing concussions.”
Dr. Manley adds, “This study demonstrates that these blood-based biomarkers are more sensitive at detecting brain injury than a CT scan. Even when we found that the CT scan was negative, the research found that these blood proteins levels were elevated above both the healthy and orthopedic controls.” As part of the study, the diagnosis of brain injury was by an MRI scan. Importantly, even when the MRI scan was negative, this protein was elevated more than it was in the controls – suggesting that similar to CT scans, it may be more sensitive than MRI imaging. “And this research suggests,” says Manley, “that proteins have the potential to improve our ability to triage patients with traumatic brain injury.”
While there are still many research milestones for TRACK-TBI, the detection of TBI and identification of patients who need brain injury treatment and care could be a significant game changer – principally for emergency situations. Using only a few drops of blood, assessment of the brain could literally, change lives in a matter of minutes.