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2012 Compendium
Mild TBI Remains Little Understood and Hard to Diagnose Cont.
- Categorized in: Battlefield Medicine, Department of Defense (DoD), Department of Veterans Affairs (VA), January 2012, NIH, PTSD, Rehabilitation, TBI
The Search for Concussion Markers
FDA Approves Handheld Scannner to Detect Brain Injury
WASHINGTON — The first handheld device intended to aid in the detection of intracranial hematomas has been approved by the FDA. Using near-infrared spectroscopy, the Infrascanner Model 1000 will help providers identify patients with critical brain injury.
The device, manufactured by InfraScan Inc. of Philadelphia, uses a scanner that directs near-infrared light, a wavelength of light that can penetrate through tissue and bone to reach inside the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a handheld computer.
The device is designed for use by emergency department physicians to provide a more-portable, less-invasive mechanism to assess whether a patient needs an immediate computed tomography (CT) scan.
By comparing the optical density from a series of scans of specific areas on both sides of the skull, a provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures.
FDA approved the device based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75% of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82% of the time.
The device was created with assistance from the Marine Corps, which provided $2 million in development funding in consideration of the Infrascanner’s potential for use in the battlefield setting. Head wounds lead to nearly 50% of combat deaths, and early identification of brain hematomas could play a significant role in the decision to attempt surgical intervention and to transport critically injured servicemembers to more advanced facilities.
The scanner is already being marketed in Europe, Russia, Saudi Arabia, Turkey and India.
Even diagnosing mTBI is not as clear-cut an issue as people imagine. While there are very solid markers for diagnosing moderate, severe and penetrating TBI, there are no objective markers for concussion. Currently, clinicians are required to talk with their patients, gather information and make a diagnostic judgment based on that conversation but using no objective scientific data.
“There’s a dire necessity to find an objective marker for concussion,” Helmick said. “We have been very much challenged and prompted by Congress to find this objective marker beyond the clinical judgment.”
There are a number of promising research avenues, including papillary response and visual tracking; biomarkers in serum, saliva and skin; diffusion tensor imaging; and electrophysiological parameters.
“This is an area of research in which a lot of money has been spent, and we feel that there’s a lot of promising work,” Helmick said. “But we don’t believe it will be one single thing, one magic bullet. It will be some combination of tests.”
Military physicians also are working on teasing apart the symptoms of commonly comorbid conditions like PTSD, TBI, chronic pain, depression, and substance-use disorder. “The longer we went on in the war, the more we realized that comorbidities were an issue,” Helmick said. “People weren’t coming back clean, with TBI as an only issue.”
To address this, DCoE put out a co-occurring conditions toolkit giving clinical guidance on how to treat patients with two or more of these diagnoses.
“It’s in its infancy. This is Version One,” Helmick said. “It will have to evolve through time. But in the grand scheme, this was an achievement.”
How to Screen for mTBI
As the science into finding objective markers continues, military physicians are searching for ways to better identify returning servicemembers who have suffered a TBI.
One way of doing this is to get a better baseline of how the servicemember was before being deployed. Currently, all servicemembers prior to deployment are required to take part in automated neuropsychological assessment metrics (ANAM) testing — a computer-based tool designed to test speed and accuracy of attention, memory and thinking ability.
If a servicemember is injured, their ANAM score can be compared to their current score, and this can help determine fitness. “It’s only one piece of data, but it’s the only objective data that we have right now, and it can help inform a return to duty decision,” Helmick said.
“Unfortunately,” she said, “Congress had mandated a different [method] — test before, get a baseline, then test everybody after. And if there are any differences, after 12 to 15 months of war, figure out why it’s different. Of the hundreds of things it could be, find out what.”
Congress considers it the largest possible safety net, ensuring that no one suffering from employment experiences is left undiagnosed, which is the same goal of the military, Helmick said.
Helmick suggested, however, that this giant safety net might not be as effective as the military’s injury-based screening paradigm and will create far more work. GAO, she said, conducted an audit and found that population-based screening using neurocognitive testing was not effective for diagnosing concussion.
“We have to figure out where we can meet on this,” she said.
One area where Congress and military leaders are in agreement is in getting new treatments into the hands of clinicians as soon as possible.
“There has been a paradigm shift in research,” Helmick said. “We’re looking for the 80% solution.” The 80% solution refers to the idea that it is better to launch a treatment that research has shown to be somewhat effective or effective in some patients, and to do so quickly enough to benefit the patients that need treatment now, than to wait for a 99% effective treatment that takes much longer to research and field.
DoD is conducting numerous studies into neuroprotection drugs, neuroplasticity after injury and cutting-edge methods of treatment and rehabilitation. For example, there are currently three major DoD studies to see if hyperbaric oxygen treatment is effective post-TBI.
“Some of this is snake oil, and it will eventually come off the radar screen,” Helmick said. “But if it’s safe and effective, leadership wants us piloting it in military cohorts.”
Coordination Among DoD TBI Research Efforts in the National Capital Area
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Blast over pressure can be dangerous but if one is not in and IED the soldier is in his (natural) evironment and incident never discussed. Even while training for combat exposure to blast, rockets can take toll over time.