FDA approves new post-concussion cognition tests

Doctors will now have a more regulated way to check if head injuries have negatively impacted patients’ cognition.

The FDA has approved a test to check for just that, according to a statement Aug. 22. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices run through laptop and tablet software to allow doctors to assess whether a concussion or other head injury has been damaging to a patient’s cognitive ability. They are the first of these kinds of tests to be approved, according to the FDA, and were designed by ImPACT Applications in Pittsburgh.

But they are not meant to diagnose or check for signs of concussion, the agency warned.

“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,” Director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health Carlos Peña, PhD, MS, said.

But for children ages 5 to 11 (ImPACT Pediatric) and children and adults ages 12 to 59, the tests will allow doctors to measure post-traumatic brain injury cognition against pre-injury levels or age-appropriate population controls. The test measures skills such as word memory and recognition and reaction time.

The tests could help doctors of the two million patients per year the CDC says visit emergency rooms with traumatic brain injuries in the U.S. figure out the best course of treatment.