Research Supporting a Lifetime of Brain Injury
Part 2 of 4
The next several years of his service will be spent in training, deployment and possibly in combat. As the battlefield of today evolves into the battlefield of the future, our military must be prepared to engage in any environment and tackle any situation, making training and readiness so invaluable.
One of the risks the Soldier bravely faces is possible injury sustained while serving his country. In many cases, this includes withstanding traumatic brain injuries. Fortunately for the Service Member, countless hours of research have greatly advanced the study and understanding of this ailment.
The Congressionally Directed Medical Research Programs manages collaborative research that discovers, develops and delivers health care solutions for Service Members, veterans and the American public. Through these programs, medical researchers are able to focus on the most ground-breaking diagnostics, treatments, and therapies, including those for brain injury.
TRAUMATIC BRAIN INJURY
The ability to diagnose, treat and prevent traumatic brain injuries is a priority for the health and readiness of our Service Members. TBI can occur as a result of a blunt impact or blast exposure that might occur during military training, but also includes recreational incidents such as athletics, vehicle accidents and even a common fall.
In 2013 there were 2.8 million emergency department visits for all severities of TBI for the American public. Statistics from 2000-2016 within the DOD show that out of 347,962 total TBI, 286,255 were mild (concussion). The range of causes of TBI for active duty Service Members between 2000 and2013, were reported as follows:
- 21 percent falls
- 17 percent motor vehicle/transportation crashes
- 16 percent accidental strike by an object or machinery
- 14 percent other
- 10 percent assault (non-battle)
- 8 percent battle injury
- 8 percent sports/athletics
- 6 percent gun and explosive accidents
THE TED INITIATIVE
The second lieutenant will have assurance that if he ever experiences a TBI, research efforts such as the TBI Endpoints Development Initiative are working to provide the tools to improve diagnosis and treatment. The management and oversight of the TED Initiative utilizes a partnership between the CDMRP and Combat Casualty Care Research Program/Joint Program Committee-6. This partnership allows the CCCRP in their role as experts in battlefield trauma care to develop the execution strategy by aligning to DOD goals, and the CDMRP, in turn, to utilize their program management expertise to manage the research awards.
"Work performed in the TED Initiative will support the development of technologies and therapeutics that will help identify and treat TBI on the sidelines, military training environment, and eventually on the battlefield," said Dr. Dwayne Taliaferro, CDMRP health sciences program manager.
This research is geared towards establishing the framework for better designed clinical trials which can provide the data to examine, identify and validate degrees of brain injury that could lead to more definitive TBI diagnosis and treatments.
"The TED Initiative is a public--private partnership that brings together industry, private philanthropy, government (funding and regulatory), academic partners, and patient advocacy efforts in order to develop and advance knowledge in the TBI community," said Dr. Christie Vu, CDMRP program manager. "This collaborative effort supports research that applies, not just to the civilian community, but the entire military life cycle."
Dr. Geoffrey Manley is the principal investigator for the TED Initiative, at the University of California, San Francisco.
"The ultimate goal of the TED Initiative is to accelerate the progression of traumatic brain injury diagnostic tools and therapeutic agents through the regulatory process," said Manley. "The U.S. Food and Drug Administration is the 'portal to the patient,' and the more support our team's data and expertise can bring to early and productive collaborations between drug and device manufacturers and the FDA, the sooner our patients [military and civilian], will have access to the care they need and that we want to deliver."
RESEARCH PROVIDING RESULTS
"We're thrilled with our progress; soon after the launch of the TED Initiative in May 2015, our team submitted information dossiers on promising blood-based and imaging biomarkers and tools," said Manley. "In March 2016, we were instrumental in helping the FDA to organize its first-ever public workshop on advancing the development of biomarkers in traumatic brain injury. Several of the blood-based and imaging biomarkers our team is most closely engaged with in validating for early confirmation of TBI, received FDA Letters of Support in 2016 and 2017 -- again, the first ever for TBI."
The FDA's Center for Devices and Radiological Health has recognized the collaborative efforts of the TED Initiative to advance clinical outcome measures that will better support diagnostic and treatment trials for TBI.
"The FDA strongly encourages the TED Initiative and the TBI community to continue to work collaboratively to share data, resources and other knowledge to accelerate advances in the TBI space to benefit individuals with TBI," said Vu.
Most recently, on February 14, the FDA cleared the use of a blood test to help determine the need for a CT scan in patients suspected of having mild TBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients. Manley explained that the company that put this forth, Banyan Biomarkers, is one of the partners in the public--private partnership that is a key feature of the TED Initiative.
FUTURE TBI RESEARCH
Manley explained that the immediate next steps in the TED Initiative are to harness the data and findings into the design of clinical trials for TBI therapeutics, and the bedside care of patients.
"When we are able to diagnose patients with a definitive type of TBI, according to its anatomic features and how this specific kind of injury may be predicted to cause specific outcomes across the person's cognitive, physical, emotional and functional experience, we will be closer to our goal of providing precision medicine acute and rehabilitative treatments for this diverse, and sometimes chronic, condition," he said.
As the second lieutenant advances in training and gains experience over the years, he can be assured that researchers are working on discovering effective ways to secure his health and wellbeing, and therefore contribute to his readiness to serve the Nation. A life of active duty military service comes with sacrifices, but healthcare should not be one.