Two new devices that can help assess head injuries and concussions are on their way to doctors.
ImPACT, and its pediatric version ImPACT Pediatric, have received the Food and Drug Administration’s okay. ImPACT stands for Immediate Post-Concussion Assessment and its manufacturer says it’s the first medical device to win that FDA okay that measures a patient’s cognitive function following a head injury.
Cognitive functions are things such as word memory, reaction time and word recognition, all of which could be affected by a head injury. ImPACT compares its measurements to an age-matched control database or to a patient’s pre-injury baseline scores, if they’re available. A doctor would use those results along with physical signs when evaluating a head 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” says Carlos Peña, Ph.D., M.S., at the FDA’s Center for Devices and Radiological Health.
ImPACT software runs on a desktop or laptop and is intended for ages 12 to 59. ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. The devices are intended for use only by licensed health care professionals.
Head injuries affect millions
According the Centers for Disease Control, traumatic brain injuries account for more than 2 million emergency room visits, and 50,000 deaths in the United States each year. A TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain.
Not all blows or jolts to the head result in a TBI. The severity of a TBI may range from “mild,” i.e., a brief change in mental status or consciousness to “severe,” i.e., an extended period of unconsciousness or amnesia after the injury. Concussions are considered to be mild traumatic brain injuries.