Concussion test designated by FDA as breakthrough device, could help minimize long-term effects

When it comes to concussions, an early diagnosis could make all the difference.

June 20, 2019, 10:00 PM

Concussions are common head injuries that can happen from something as simple as a fall. But they can often be missed by medical health professionals, especially if the symptoms are mild or delayed.

A quicker, more precise method for diagnosing concussions, also known as mild traumatic brain injuries (mTBIs) may be on the way. The Food and Drug Administration has designated a portable test for diagnosing and potentially even predicting outcomes in mTBI patients for its Breakthrough Devices Program, which fast-tracks the development, testing and approval of new devices that have the potential to change medical care for life-threatening or debilitating conditions.

The device, made by the company BRAINBox Solutions, is a blood test to determine if they’ve had a concussion and will be compared with both computerized imaging of a patient’s brain function and clinical diagnosis tools to test its accuracy.

“We don’t have any tools right now that are really good or accurate [for diagnosing TBI],” Dr. Damon Kuehl, an emergency medicine physician at Carilion Clinic and associate professor at the Virginia Tech Carilion School of Medicine, told ABC News.

“The real goal is [for this to be] an accurate and quick test that can be accessed by trained professionals right at the moment of injury or later on,” said Kuehl, who will be working on a trial of the new test. “Not only will it give us a diagnosis but also a predictive ability, a little bit of a crystal ball for concussions.”

A TBI is caused by a bump, blow, or jolt to the head that disrupts the normal function of the brain. Mild TBIs, also known as concussions, are the most common kind of TBI, and they can happen to anyone — even though they are often spoken about in relation to contact sports like football or hockey.

“Young people, old people, soldiers [and] athletes in certain sports are very susceptible to brain injuries,” said Dr. Michael Friedlander, executive director of the Fralin Biomedical Research Institute at VTC where the test will be studied. He added that “a brain injury is something any one of us may experience at any time.”

The test would allow for better outcomes because it would accurately determine early on whether a patient has experienced an mTBI, Friedlander told ABC News.

“If you don’t have an [mTBI], you wouldn’t need to be subjected to treatment,” Friedlander said. “If you do have it, your physician can plan rehabilitation for you to minimize these effects.”

Friedlander said the trial will test people in hospital emergency rooms as well as athletes from Virginia Tech who have potential mild brain injuries. It will then compare their results with people coming into the same emergency rooms and from the same teams without symptoms.

Symptoms from concussions frequently go away quickly between a week and 10 days, however, some people’s symptoms may take longer to go away — possibly even lasting the rest of their lives. Symptoms of a concussion include difficulty thinking or remembering, headaches and dizziness, irritability or sadness and difficulty sleeping. Because of this, it can be misleading to think that a concussion is only a minor injury, the researchers say.

“The idea that a traumatic brain injury could be mild is misleading because these injuries have multiple downstream effects on a person’s behavior and day-to-day functioning, especially if the diagnosis isn’t made,” Dr. Stephen LaConte, lead researcher and associate professor at Fralin, told the Virginia Tech Daily.

Concussions that are left untreated or not treated well enough can leave patients “floundering with persistent symptoms and impairments, not knowing the reason for them,” said Dr. Kirk Lercher, medical director of brain injury medicine at Mount Sinai Hospital in New York City.

Lercher, who will not be involved in the trial, believes the new test has “a lot of potential to be a game-changer in how we diagnose [mild TBIs],” but said there needs to be more research first.

TBIs are a serious public health concern in the U.S., resulting in death and disability for thousands of people each year. In 2014, there were nearly three million TBI-related emergency room visits, hospitalizations and deaths in the U.S., including over 837,000 cases in children alone.

Dr. Heidi Choe is a physician from the Department of Rehabilitation and Human Performance at Mount Sinai Hospital in New York City and a member of the ABC News Medical Unit.