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FDA Clears First-Of-Their Kind Tests To Help Identify Concussions

This article is more than 7 years old.

Public awareness about the risks of concussions may be on the rise, but many concussions are still flying under the radar of health professionals. This week, the FDA has sanctioned two computerized tests, the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, that may be able to help.

The ImPACT tests are the first medical devices to be approved by the FDA intended to assess patients’ cognitive function following a possible concussion. Developed by Pittsburgh-based company ImPACT Applications, the neurocognitive tests calculate an individual's scores on a series of tasks to determine verbal and visual memory, processing speed and reaction time.

The tests aren’t meant to definitively diagnose concussion though. Rather, the FDA says they are “intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.”

Symptoms of concussion may include disorientation or confusion immediately after a blow to the head, impaired balance, slowed reaction times and impaired ability to recall information. Headache, dizziness and nausea may also occur.

Currently, there’s no easy test to diagnose a concussion. Instead, doctors rely on the observation or self-reporting of patients’ symptoms, as well as physical exams consisting of strength, sensation, reflex and coordination tests. In an emergency room setting, a concussion may be more apparent, especially if the injury has just happened or the patient has experienced a brief loss of consciousness.

But concussion symptoms can be subtle or even delayed several days after the initial injury. As a result, many concussions are diagnosed in a primary care setting. A May 2016 study appearing in JAMA Pediatrics found that 82% of children visited their primary care doctors following a concussion rather than an emergency department.

Brain imaging like MRI or CT scans are sometimes used when determining a concussion diagnosis. But since concussions don’t cause visible structural injury to the brain, these imaging techniques are typically used to rule out more serious brain injury, like bleeding or swelling in the skull.

The ImPACT tests are meant to be an extra tool in both the emergency and primary care settings to help determine if a concussion has occurred.

The tests are already a popular assessment method—NASCAR made ImPACT mandatory for baseline concussion testing of drivers beginning in 2014—but the FDA clearance will help bolster the tests’ visibility and open up new potential markets and access to hospital networks. According to ImPACT Applications, researchers have evaluated its efficacy in 280 peer-reviewed papers and 145 independent studies over the past 14 years.

Traumatic brain injuries account for more than 2 million emergency room visits in the United States each year and contribute to the deaths of more than 50,000 Americans, according to the U.S. Centers for Disease Control and Prevention. A significant percentage of these injuries are considered to be mild ones, which include concussion.

By many estimates, concussions are likely underreported in both children who play recreational sports and adults who compete professionally. Afflicted individuals may not recognize their symptoms as ones that point to concussion, or they may have a neck injury, which mimics some concussion symptoms. In addition, athletes may be reluctant to report these injuries because of concussion protocols that could limit playing time.

The potential for long-lasting brain injury as a result of repeat concussions is becoming a heightened public health concern as more research on chronic traumatic encephalopathy (CTE) emerges. Several studies have found evidence of CTE, a progressive degenerative brain disease, in the brains of football players, hockey players and boxers, as well as in military combat veterans. Despite a suspected link for year, the National Football League only recently acknowledged the link between football and CTE.

Some researchers are searching for more conclusive ways to diagnose concussions in order to better identify patients and prevent repeat or long-term brain injuries. For example, investigators at the nonprofit Orlando Health are developing a blood test designed to detect a protein released by the brain following injury that can stay in the bloodstream for up to seven days. They analyzed 152 children who had sustained a concussion within the past six hours and found that the blood test detected brain injuries with 94% accuracy. The results were published in May in JAMA Neurology.

In recent years, the National Institutes of Health and Department of Defense have helped spur development in concussion research, and companies like Abbott, Banyan Biomarkers and Quanterix are also investigating diagnostic blood tests. But so far, none have been approved by the FDA.

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