The U.S. Food and Drug Administration (FDA) recently approved of marketing for two new computerized cognitive tests to determine a person’s cognitive functioning after receiving a suspected concussion or brain injury.
Called the Immediate Post-Concussion Assessment and Cognitive Test (ImPACT) and ImPACT Pediatric, the test is the first of its kind. There have never before been approved medical devices to evaluate cognitive functioning after a potential concussion.
The test does not diagnose concussions or prescribe treatments. Rather, the test uses tools to evaluate word recognition, reaction time and word memory, which could be changed with a head injury. The patients’ responses are compared to age-matched control database or pre-injury baseline results.
ImPACT uses laptop or desktop software to operate. It is useful for people between the ages of 12 and 59. ImPACT Pediatric is available on an iPad, as well. It is designed for children between the ages of 5 and 11. Licensed health care professionals are the only ones who should operate the test and explain the results.
"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," Dr. Carlos Peña, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health, said.
