Government and Regulations

TBI Biomarker Development on the Horizon

Joint VA/DoD efforts to identify and address research gaps in traumatic brain injury treatment and prevention are beginning to produce results.



A number of advanced efforts in traumatic brain injury (TBI) research are on the verge of reporting new data, according to a roundtable discussion that took place during the Military Health System Research Symposium on August 19. Among the most notable is in the area of biomarker development.

A 2,000-patient pivotal trial recently closed, and analysis should be completed by the end of the year. By March 2016, the research team expects to submit for FDA clearance a first-ever blood test for TBI. In addition, TBI research is currently being conducted in the areas of eye movement and balance.

Related: Brain Training for TBI Patients

A problem with assessing and treating the complexities of TBI up to this point is that although there are hundreds of measures of brain function, the evidence isn’t strong enough to provide a gold standard. “The whole area of drugs in neuroscience has been very difficult,” said Col. Dallas Hack, MD, senior medical advisor to the principal assistant for research and technology. “We have a couple of major efforts that are aimed at solving the problems of achieving results that can be measured according to the standards required to have them approved.”

Related: Stopping TBI-Related Brain Degeneration

To address the lack of a gold standard, the TBI Endpoints Development multiyear effort is making progress to give validity to the many existing measures of brain injury. Another effort is the VA/DoD Chronic Effects of Neurotrauma Consortium (CENC), a federally funded program that identifies gaps in research and provides support services for scientific, clinical, and translational research projects focused on the long-term effects of mild TBI in veterans and active-duty service members.

For information about the CENC, click here.

Next Article:

The VA/DoD Chronic Effects of Neurotrauma Consortium: An Overview at Year 1

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