In August, the FDA approved two medical devices that can assess cognitive function immediately after a suspected brain injury or concussion. These tests are the first of their kind that the FDA has allowed to be marketed.
The tests – Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric – are the first devices permitted for marketing that assess cognitive function following a potentially concussive injury. Both tests are intended to be used as part of a complete medical evaluation by physicians or other health care personnel trained in assessing signs and symptoms of head injury; the tests are not intended to diagnose concussion or determine possible treatments.
ImPACT is conducted on a desktop or laptop and is designed for patients aged 12 to 59. The more game-like, ImPACT Pediatric, is conducted on a tablet and is designed for patients aged 5 to 11. The tests assess cognitive skills such as word memory, attention span, nonverbal problem solving, and reaction time; the results are compared to an age-matched control database or a patient’s pre-injury scores, if any are available. The manufacturer – ImPACT Applications in Pittsburgh, Pennsylvania – reports that they currently have 17,000 cases in the normative, control database.
In order to gain FDA approval of ImPACT and ImPACT Pediatric, the manufacturer submitted results of more than 250 peer-reviewed device analyses. More than half of these were independent, clinical research studies. Together, the studies resolved that the devices were valid and reliable and able to detect evidence of cognitive dysfunction. The FDA determined that ImPACT and ImPACT Pediatric were safe and effective. Therefore, the results supported the marketing of the devices through a de novo classification process – a regulatory pathway for new, low- to moderate-risk medical devices that are the first of their kind.
Traumatic brain injuries (TBI) account for more than 2 million emergency department visits each year in the United States. More than 50,000 Americans die from TBI annually. Concussion, a subset of mild TBI, is a traumatically induced transient disturbance of brain function that involves a complex pathophysiologic process. As many as 3.8 million concussions occur during competitive and recreational sports in the United States, but approximately half go unreported.
Concussions, especially in sports and the military, are common. However, they are difficult to diagnose, and under-reporting remains a public health burden. Many systems for preventing, assessing, and treating concussions are being investigated and developed, but many questions remain unanswered. Long-term consequences of concussion are still unclear, as well, with pervasive alterations in attention and executive control apparent after a single concussive incident during childhood.
Concussion is a clinical diagnosis that must be made by a health care provider who is familiar with the patient and can recognize and evaluate a concussion. Symptom checklists are objective for evaluating a variety of symptoms related to a head injury, and some standardized assessment tools offer structure for evaluating concussion. Biomarkers are being investigated as potential diagnostic and prognostic tools. Much more research is needed to validate current assessments, and new technologies may provide new insight for diagnosing, evaluating, and managing concussions.
Any mechanism, including the new ImPACT systems, that can raise awareness of concussion and assist in identifying cognitive injury, may offer an important direction for combating concussive injuries in the future.
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U.S. Food and Drug Administration. FDA allows marketing of first-of-king computerized cognitive tests to help assess cognitive skills after a head injury. News release. August 22, 2016. http://ift.tt/2dVdygs.
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