By BRAINBox Solutions
VTCRI leads effort to develop test for mTBI with industry partners, University of Virginia
Scientists at two of Virginia’s largest universities, working with clinicians from the two major health systems and a growing Virginia-based biotechnology company, have teamed up to address an important medical challenge — how do you accurately diagnose a mild traumatic brain injury that has subtle or no physical signs but can cause long-term damage?
The project has won the support of the Virginia Catalyst, formerly known as the Virginia Biosciences Health Research Corp., which has awarded a $500,000 grant to the Virginia Tech Carilion Research Institute (VTCRI) to further develop and commercialize a multi-modality system approach to aid in the diagnosis and management of mild traumatic brain injury, known as mTBI.
A core component of the system is a blood-based test that can also be administered directly at the point of care, providing rapid results. The VTCRI will serve as the first anchor research and demonstration site.
Brain injuries, including concussions, can be silent and occur without any loss of consciousness. “Crucial decisions have to be made at the time of a head injury,” said Mike Grisham, chief executive officer of the Virginia Catalyst. “It is essential to develop a comprehensive approach to determine whether people can safely return to school, work, the sports field, or the battlefield — or whether they need additional therapy.”
The funds will be matched by an additional $500,000 to be invested in the program by the project’s industry partner, BRAINBox Solutions Inc., the emerging entity out of ImmunArray, a molecular diagnostics company, to accelerate its TBI program. They are working to develop a comprehensive blood test that combines analysis of multiple biomarkers to help predict short- and long-term complications of mTBI.
“This is a game changer,” said Donna Edmonds, a former critical care nurse who is now the chairman and chief executive officer of ImmunArray Ltd. and will lead BRAINBox Solutions as its CEO. “The brain is extremely complex and to understand what is going on during a head injury, it takes a multi-biomarker, multi-modality approach. Our method includes a test utilizing a sample of whole blood placed on a cartridge or analyzed in a hospital-based laboratory. The ‘point of care’ test will be plugged into a handheld device, and within about 30 minutes, you have a result.”
Edmonds is leading a panel discussion today (Wednesday, May 16) on the benefits of combining multiple systems to quickly diagnose and monitor head injuries during the 8th Annual Traumatic Brain Injury Conference, an international conference in Washington, D.C.
“VTCRI scientists are determined to find scientifically sound, practical solutions to the nation’s most pressing health problems,” said Michael J. Friedlander, the executive director of the Virginia Tech Carilion Research Institute and principal investigator for the project. “The institute’s researchers are seeking a precise, robust field test to diagnose mild traumatic brain injury, which is an under-researched health problem that affects people of all age groups, with particular impact among children, athletes, military personnel and older adults.”
Co-principal investigator Stephen LaConte, an associate professor at the Virginia Tech Carilion Research Institute, and Friedlander, will work with investigators at the University of Virginia to conduct research to compare the readings produced by the diagnostic test with readings from both structural and functional MRI brain scans and cognitive tests.
“Mild traumatic brain injury is not always obvious, but it accounts for most brain injuries,” said LaConte, who is also an associate professor in the Department of Biomedical Engineering and Mechanics in the Virginia Tech College of Engineering. “We know all sorts of downstream effects on a person’s behavior and day-to-day functioning can occur if the diagnosis isn’t made. It’s a national problem, for children and adults.”
The VTCRI team will collaborate with colleagues at the University of Virginia to refine BRAINBox Solutions’ sophisticated biomarker technology and its multi-modality system. Currently, the state-of-the-art method for diagnosing mild traumatic brain injury is limited to neurocognitive tests. Now, by looking into a person’s cognitive performance during advanced brain imaging, researchers will determine the accuracy and relationship of blood biomarkers indicating brain injury.
Joshua Easter, an emergency department physician; Donna Broshek, a neuropsychologist; and James R. Stone, an interventional radiologist and neuroscientist, all at the University of Virginia Health System, will perform parallel diagnostic blood tests, neuroimaging, and neuropsychological studies in Charlottesville as part of the collaborative program. In addition, Carilion Clinic emergency department physician Damon Kuehl, a faculty member with the Virginia Tech Carilion School of Medicine, will recruit patients seen in the emergency room to participate in the mild traumatic brain injury research.
Meanwhile, the athletic departments at the University of Virginia and Virginia Tech, including Virginia Tech football team physician Gunnar Brolinson, the vice provost for research at the Edward Via College of Osteopathic Medicine, are expected to recruit volunteers for part of the research program.
“Both the University of Virginia and Virginia Tech have access to great emergency and athletic departments,” LaConte said. “Virginia Tech brings a history of research in athletics and concussions, including biomechanics and helmet instrumentation research by Stefan Duma (the Harry Wyatt Professor of Engineering and the director of the Institute for Critical Technology and Applied Science) and his team. We added brain imaging to a track record of research productivity with Virginia Tech athletics and Carilion Clinic’s emergency medicine department. UVA mirrors those exact themes. We were able to put all the pieces together. It is very exciting.”
Ultimately, the effort will reveal what the brain is doing functionally in the context of results from neurocognitive testing and the profile of blood-borne biomarkers that reflect the injury and restoration processes under way in the brain, according to Friedlander, who is also the vice president for health sciences and technology at Virginia Tech.
Traumatic brain injury is a major cause of death and disability in the United States, according to the Centers of Disease Control and Prevention. TBIs contribute to about 30 percent of all injury deaths. Survivors of TBI can face effects that last a few days or the rest of their lives.