A little over two decades ago, military scientists sat around a conference table to eat breakfast and discuss biological clues for diagnosing traumatic brain injuries among service members. The meeting took place at a combat casualty conference in St. Petersburg, Florida, where researchers and doctors discussed TBIs soldiers could suffer on the battlefield.
It was the morning of Sept. 11, 2001.
Within days, the U.S. would enter a series of wars that would last nearly two decades and TBIs would become “one of the signature injuries of troops wounded” in those conflicts. Since 2000, over half a million troops have been diagnosed with at least mild TBIs from combat or training.
That meeting on the morning of 9/11 “marks the inception” of the Defense Department’s involvement in TBI blood-based biomarker research, said Damien Hoffman, biomedical engineer and product manager for the Army’s traumatic brain injury tool.
More than 20 years later, the Army co-developed a test that researchers could not have envisioned that morning: A battlefield device that, by testing a single drop of blood, can give combat medics better insight into a soldier’s head injury.
The Analyzer Traumatic Brain Injury program is a test developed by the Army in conjunction with Abbott Laboratories. With one drop of blood, the ATBI device can detect early indications of a potential TBI within 15 minutes, researchers said.
The test looks for a pair of biomarkers, GFAP and UCH-L1, that show up in the bloodstream soon after a brain injury, according to the Army.
The impact of having such a test in the field could be large.
For a field medic, a negative test could rule out the need for a complicated or even risky evacuation to a larger medical facility for a head computed tomography or ‘CT’ scan.
And beyond the frontlines, knowing who needs evacuation, and who can wait may be key information in the future. In Iraq and Afghanistan, the U.S military medically evacuated countless troops for treatment of suspected TBIs. But in a conflict where the U.S. might not have air superiority, Hoffman said the test can help the military limit evacuations, treat troops locally and get those healthy enough back to the front lines.
“Given the large numbers of expected casualties with all severities of traumatic brain injury in future large-scale combat operations,” the test can help medical providers prioritize more severe cases and “eliminate unnecessary evacuations,” Army Lt. Col. Bradley Dengler, neurosurgical consultant to the Surgeon General said in a release.
During U.S. operations in the Middle East over the last two decades, Hoffman said the U.S. had an “over reliance” on evacuations. Army research has since determined that the test “may have” prevented 30 to 35% of all rotary-wing evacuations for isolated mild TBIs during counter insurgency operations in Iraq and Afghanistan between 2002 and 2018, he added.
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Before the device, mild TBIs had been a challenge to assess, with the CT scan as the “gold standard,” according to Hoffman. Otherwise, medical providers were left with basic diagnostic skills like checking a patient’s eyes or an interview — an approach that’s less than definitive.
“Aside from imaging, the only other clinical information that the clinician had to make their decision on was really subjective,” he said. “Your level 10 headache may be a level 11 headache for me. You and I don’t know that difference and the clinician won’t know. We’ll just say that we have a really bad headache.”
The tool was approved for use by the U.S. Food and Drug Administration in March. In 2025 — but possibly earlier — the Army plans to field the tool, first to large and small hospitals, followed by “Charlie Med stations,” company-sized units that provide care for brigades.
While the tool has not been widely deployed, it was tested with troops in the U.S. and others deployed to support U.S. Central Command operations. In July 2023, the tool was tested during a medic combat training exercise at Fort Hunter Liggett, California. In the Middle East, separate tests were analyzed by military labs in the region in Kuwait and Baghdad.
“By providing this capability to CENTCOM, we got real data from the operational community on the utilization, on the impact to their clinical practice and their clinical decision making that the [Analyzer Traumatic Brain Injury] will have once it goes live,” Hoffman said.
Soldier brain health
The tool is part of the military’s focus on troop brain and head injuries that have prompted millions of dollars in research, new offices and programs that consider these issues early in service members’ careers. In August, the Pentagon announced that the services would conduct baseline cognitive assessments during Initial Entry Training. Along with the assessments, the Defense Department also published new rules on safe distances to limit troops’ exposure to heavy blasts or what the military calls “blast overpressure.”
In the Army, officials plan to evaluate soldiers’ cognition every three years after their initial screening for early intervention and to “identify any unusual cognitive change,” according to an Army release. While the schedule and ongoing evaluations are new, the testing is part of a program that began in 2007. For nearly two decades, over 3.4 million assessments have been collected, analyzed, and stored at the Neurocognitive Assessment Branch Data Repository at Joint Base San Antonio, Texas.
Those same cognitive tests were mandated for troops deploying to combat in Iraq and Afghanistan through the Department of Defense Automated Neuropsychological Assessment Metrics center. The computer-based test is used as a baseline assessment and detects “speed and accuracy of attention, memory, and thinking ability,” according to an Army release.
Ongoing TBI research
With the ability to assess TBIs faster and more accurately, research in the civilian and military worlds are expanding what two of the main TBI blood biomarkers (GFAP and UCH-L1) can teach scientists about treatment and other diseases.
“Getting the rule-out test was the tip of the iceberg for these two biomarkers, in my opinion,” Hoffman said.
Other research within the Army tool portfolio is looking at how biomarkers can aid in the development of drug treatments for TBI, he added. Researchers are also testing oral treatments for moderate TBI and intravenous and intramuscular TBI drug treatments for severe TBI, according to the Army.
“There is interest in seeing if we can determine return to duty or recovery rate based on maybe the decrease in the biomarkers at an ‘X’ rate and at what point you are considered mission capable,” Hoffman said about a possible separate line of study.
Two studies published this month also highlighted the importance of biomarkers in further research. One study reiterated the Army’s analysis that biomarkers “obtained this early after injury could inform decision-making” such as prehospital transport to trauma centers, military theater evacuations to medical facilities, and sports-related brain injuries on the sidelines.
The FDA’s first approved blood test for evaluating mild traumatic brain injury has even led researchers to look at how blood markers may help with diagnoses for a host of other fatal health conditions like viral infections and bacterial sepsis, according to a new Navy medical research study published earlier this month.
UPDATE: (10/8/2024); An earlier version of this article stated that the tool was approved by the FDA in April. The approval was made in March and announced in April. The article also said that the test diagnoses TBIs. The test detects biomarkers that can indicate TBIs, but does not diagnose the injury.
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