Computerized Cognitive Tests May Help Assess Patient Cognitive Function After Brain Injury
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Computerized Cognitive Tests May Help Assess Patient Cognitive Function After Brain Injury

Two new devices that may help doctors assess patient cognition have been approved for marketing

August 23, 2016

The U.S. Food and Drug Administration (FDA) has allowed marketing to go forward for two new devices that can help doctors to assess patient cognitive function after a suspected brain injury or concussion.

The devices, known as the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, are the first devices of their kind to be approved for marketing. They are intended to be part of the medical evaluation performed by doctors when assessing patients for signs and symptoms of head injuries.

Although they are meant to be part of the assessment process, the devices are not meant to be used to diagnose concussions or determine correct treatments on their own. They are rather intended to test a patient's cognitive skills that could be affected by head injuries, such as word memory and recognition as well as reaction time. The results of the tests are then compared to a control database matched to the patient's age or, if available, the patients' baseline scores before receiving the injury.

"These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game," said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health.

ImPACT software is meant to be used by patients aged 12 through 59 and will run on a desktop or a laptop; ImPACT Pediatric runs on an iPad and is designed for children aged five through 11. Only a licensed healthcare professional should run a test and interpret its results.

The U.S. Centers for Disease Control and Prevention estimates that more than two million visits to the emergency room every year are due to traumatic brain injuries, and that such injuries play a part in the deaths of more than 50,000 Americans. Many such injuries are considered mild, such as concussions.

Device manufacturer ImPACT Applications submitted more than 250 peer-reviewed articles to the FDA, half of which were clinical research studies conducted independently. These articles analyzed the devices' scientific value, including their validity, reliability, and ability, in order to detect evidence of cognitive dysfunction that could be associated with concussive head injuries. These studies, concluded the FDA, provide valid scientific evidence in support of the devices' safety and effectiveness.

The devices were evaluated by the FDA using its de novo classification process, which is a regulatory process designed for first-of-a-kind, low-to-moderate-risk medical devices for which special controls in addition to general controls can be developed in order to provide a reasonable assurance of the devices' safety and efficacy.