Trials for traumatic brain injury blood test underway
WASHINGTON (June 6, 2012) -- The Army is now running trials on a blood test, similar to one used to test blood sugar, that can be used by medics on the battlefield to determine if a Soldier has sustained damaged brain cells, especially from a mild traumatic brain injury, also known as TBI.
"We've actually found some unique products, proteins in the blood that are only present when brain cells are damaged," said Col. Dallas Hack, a doctor, and director of Combat Casualty Care at Medical Research & Materiel Command, Fort Detrick, Md.
The proteins they've found to be the most sensitive and specific for acute brain injury are called UCHL1 or ubiquitin carboxyl-terminal esterase L1, and GFAP or glial fibrillary acidic protein.
Hack said the more serious the brain injury, the more of those proteins get into the blood.
One of the problems with brain injuries, Hack said, has been knowing if somebody has damage to their cells.
"We have ongoing clinical trials right now in patients and we have some articles that have now been published in peer review literature that show a really good sensitivity and specificity," Hack said. "This test is both specific (in that) it measures that brain cells are damaged, and it's sensitive enough to be able to find when even mild brain injury occurs."
One challenge in developing the test is doing studies on the battlefield.
"We actually have a current study going on with a limited number of troops out there in Afghanistan," Hack said. "We're assessing them immediately after an exposure to a blast and comparing those individuals with others who haven't been exposed to a blast over there, and comparing them to people in our civilian trials back here in the United States."
Right now, Hack said, there is currently no objective way to diagnose if a Soldier has mild TBI. Tests now for TBI might involve asking a patient questions and seeing if they are able to answer properly. Also, patients can be asked to do a balance test, or to repeat some words, or to follow an object.
"All of those require your active participation, and there's a variety of things that make those relatively inaccurate," he said.
The current trial is designed to obtain the data that would enable the Army to file for Food and Drug Administration clearance of the test for head injury. Multiple U.S. and international sites are part of the study, which is expected to be complete before the end of 2013, with plans to file an application with the FDA shortly thereafter.
WORKING WITH INDUSTRY
In order to make the TBI test work, Hack said, the Army must partner with industry in its development. Working with industry is a collaborative experience that has yielded many new ideas on how to solve problems in battlefield medicine, Hack said.
One place where industry and the Army come together is at the Military Health System Research Symposium, which has been happening for about 15 years now.
"The blood test for TBI was actually started at one of these conferences. The morning of 9/11, before things happened, a breakfast meeting was going on with the researchers from the University of Florida and our researchers from the Walter Reed Army Institute of Research," Hack said. "We met and agreed to work on this blood test for brain injury program."
Hack said the conference brings together "really amazing" scientists, who bring new ideas and a new level of energy to military health research. The conference, he said, facilitates interaction between stakeholders in military medical research.
"This conference really contributes to finding solutions for battlefield medicine," he said.
The next conference, August 13-16 in Fort Lauderdale, Fla., will involve full Army, Navy, and Air Force participation.
NEUROPLASTICITY -- ANOTHER BREAKTHROUGH
"I think we have some exciting new things going on in the area of traumatic brain injury that are coming along, both in the diagnosis and the rehabilitation areas," Hack said.
Not only is the Army working hard to develop new drugs, it is also working to develop new rehabilitation strategies, including neuroplasticity. That, combined with rehabilitation, can accelerate recovery from TBI.
"One of the things we traditionally thought in the medical community was that you're basically born with all the cells you're going to get in your brain, and you don't grow cells as time goes along and at a certain point the connections stay very static in the brain," Hack said.
That understanding of the brain is not proving to be completely true, Hack said.
"What the Army is finding are ways to re-wire the brain, combined with advanced rehabilitation techniques," Hack said.
During the recovery of Rep. Gabby Giffords, for instance, some of the rehabilitation techniques that were used with her along the way were developed as part of Army efforts. Giffords is making major progress now that wouldn't have been conceived of a few years ago, Hack said.
Hack said the human brain has been an under-addressed area of medicine.
"A lot of work has gone into strokes and we've made very little progress on that," he said. "Brain injury has had very little effort, comparatively. Spinal cord injury, on the other hand, has had a fair amount of effort."
The whole area of neuroscience has been rejuvenated since the military began showing interest in 2007, Hack said.
"I go around and talk to a lot of universities and other places and they say there's almost a renaissance in neuroscience," he said. "The military has energized a whole community by what we're doing."