A new research study at the Carilion Clinic has the potential to solve an emergency room headache: diagnosing traumatic brain injury in older adults.
The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, awarded a $3.5 million grant to Carilion of Roanoke and its partners – the University of Pennsylvania and the Richmond-based biotech company BRAINBox Solutions – to conduct the research study.
Ten million people go to the emergency room each year for head injuries and most of them are elderly people who fall. Patients may undergo a CT scan to determine if there is bleeding or a skull fracture. But CT scans aren’t sensitive enough to detect more minor injuries that could lead to worsening symptoms later on. Typically, less than 10% of CT scans show anything abnormal.
If there is no clear evidence of injury, ER doctors send the patient home as there are currently no other tests to determine if they have a brain injury.
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MRIs offer a more complete picture, but with the number of Roanoke Valley patients coming in for falls, there’s no way to give everyone an MRI, said co-lead investigator Dr. Damon Kuehl of the study and vice president of emergency medicine.
Kuehl said he has seen patient after patient come to the emergency department and is frustrated with the lack of testing capacity, especially for the elderly, who may also have dementia or Alzheimer’s disease. . If a patient has a slow reaction time or poor memory, it is difficult to tell whether this is a normal symptom of aging, dementia, or signs of brain damage.
But the solution could be in the blood.
Kuehl said BRAINBox Solutions worked with Carilion and the University of Pennsylvania to identify what are called biomarkers, or different proteins in the blood, that are present after brain injury.
When someone hits their head, the brain releases certain proteins that could indicate an injury has occurred. This could help doctors better determine if someone needs further evaluation like an MRI or therapies to address symptoms.
Carilion also worked with BRAINBox on a study called HeadSMART II to identify biomarkers in the blood of younger populations that would indicate mild concussion. But older people with dementia were excluded from this study due to biomarkers already present in their blood from the disease and other cognitive impairments they may be experiencing.
“It’s a major endpoint for any brain injury study that’s going on around the world,” Kuehl said. “If you have dementia, you can’t be part of it. This population was ignored.
Kuehl told BRAINBox executives they may be missing a large population of emergency room users who needed a better test for brain damage.
He and other researchers worked last summer to apply for the grant to fund their study. The Kuehl and BRAINBox researchers believe there are biomarkers in the blood that could be used to identify brain damage in an elderly patient that are different from those that arise from dementia.
Older brains have less plasticity and a weaker blood-brain barrier, so proteins will leak out more easily after a fall or traumatic injury, Kuehl said. If they could come up with a simple blood test that would give results in 10 minutes, they could intervene early and possibly prevent the falls from happening again.
“We now know that these types of injuries, especially if they keep recurring, cause dementia, they cause people to develop early-stage Parkinson’s disease,” he said. “And that also means that once we actually have a definitive way to diagnose you with brain injury, we now have a way to start developing medical therapies, drugs and targets to protect you or treat it.”
Kuehl said there is evidence that if a person is treated soon after a fall, they have much better results. This may include visits to the brain injury treatment center, physical therapy, occupational therapy, or consultations with specialists and neuropsychologists.
And once doctors are able to identify patients who have suffered traumatic brain injury, it opens the door for companies to develop drugs that could treat it.
Lee Perren took part in the HeadSMART II trial after he and his wife were hit by a car in Blacksburg the day before their 14th wedding anniversary. He was airlifted to Roanoke and released later that evening. In the ER, Kuehl asked him to be part of the study and he immediately said yes.
Perren works with the US Army Corps of Engineers and interacts with military personnel, who he knows have a higher potential for brain damage. Knowing that the study could help everyone from the military to athletes and now the elderly made him excited to be a part of it.
“It’s fantastic to be able to know that my negative experience can be used to help other people and potentially such a large population of people.” he said. “It might even end up helping my own family members.”
The new geriatric study will enroll 300 patients with traumatic brain injury and 70 patients as controls. Each patient will be followed for one year and patients will be enrolled over a two-year period.
BRAINBox CEO Donna Edmonds said the company also plans to open a pediatric trial later this year.
“We are grateful for this additional funding, which provides us with the opportunity to extend our technology, clinical and scientific evidence to this important population,” Edmonds said in a press release. “With this grant, we are one step closer to our goal of developing (traumatic brain injury) tests for all patient groups.”