Experts: FDA approval of concussion test means little

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In August 2016, Food and Drug Administration granted approval—its first—to two tests of cognitive function after a suspected concussion, one of which is the Immediate Post-Concussion Assessment and Cognitive Testing, or ImPACT.

This was news to us considering that we scrutinized this test in our May 2012 report “Collision Course: The Truth About Concussion Prevention.” In fact, the test has been in use for years. A new wrinkle is that the company that sells ImPACT (also known as ImPACT) now has a similar test that’s called ImPACT Pediatric, which is aimed at children ages 5–11. (The original ImPACT test is meant for people ages 12–59.)

The tests work essentially the same: Before a sports season or other period of activity, an individual takes a computerized test that’s based on a number of factors, such as memory or reaction time. If a concussion were to occur, a post-injury test is administered in the same manner, and the results are compared to the original, or baseline, test. As soon as the individual’s post-injury test matches his/her baseline score, he/she supposedly can resume play.

However, four experts in the field of neurology and neuropsychology who spoke with Consumers Digest say FDA approval doesn’t address criticisms of the test. The most damning of the criticisms is the unreliability of test results, which can be affected by a lack of sleep, problems with medications and even, in one case, touchy computers, according to Dr. Robert E. Sallis, who is a sports-medicine doctor in California and the longtime team physician at Pomona College.

Ultimately, FDA approval doesn’t mean anything other than ImPACT can use it as a marketing tool, two experts say. “FDA didn’t say it was valuable,” Sallis says. (ImPACT’s answers to our questions clearly indicate the value of FDA approval as a market differentiator.)

Christopher Randolph, who is a clinical professor of neurology at Loyola College and co-authored multiple studies that demonstrated the unreliability of concussion testing, notes that ImPACT was approved under so-called de novo submission. “The bar for approval is low,” he says, adding that all that ImPACT had to show, in effect, was that test itself was safe to use.

William Barr, who is the director of neuropsychology at New York University School of Medicine, says he expects other companies that market similar tests to health-care facilities to follow suit in seeking FDA approval. ImPACT got there first, because it had deeper pockets than did its competitors, he says.

Two experts say that focusing on the symptoms of concussion still is a better path to prevent further injury than is looking at test results.

“If [a player] still has symptoms, I don’t care if the test is positive or negative, I’m not letting him go back to play,” Sallis says.

As for the new test for younger children, three of the experts whom we interviewed believe that it would be even less useful than is its more-established counterpart.

“Kids are more variable in general” in terms of maturity and development, Barr says. “One of the issues of ImPACT with the older group is the reliability of the measure. I only believe that it’s more unreliable [for kids].”

—W. Christensen