We like to use smartphone apps for just about everything these days, but the Food and Drug Administration (FDA) is urging people to steer clear of those that claim to evaluate, diagnose, or treat head injuries including concussions.
The apps are often marketed to coaches and parents, claiming they are ideal for use during sporting events. But the FDA warns that none of them are approved and they violate the law. As such, they could result in a misdiagnosis and allow a serious injury to go untreated.
The apps enable a user to perform tests via smartphone or tablet to assess changes in memory, vision, concentration, balance, and speech.
“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” Shuren added.
Concussions can be challenging to diagnose, explained Dr. Elizabeth Matzkin, chief of women’s sports medicine at Brigham and Women’s Hospital. She said several tests have been studied and deemed unreliable or inconsistent. That’s why it’s so vital to see a physician.
“A concussion is difficult enough to diagnose with a thorough evaluation by a physician,” she said.
Symptoms of concussion include loss of consciousness for more than one minute, inability to stay awake, vomiting, seizure or convulsion, severe headache, double vision, changes in behavior, and neck pain. Family members should monitor a child for any of those “red flag” signs, Dr. Matthew Lorincz, a sports neurologist at Michigan Medicine (University of Michigan) and the co-director of Michigan NeuroSport, noted.
“The problem is, symptoms of concussion do not necessarily appear immediately after the injury,” said Sarah Clark, MPH, an associate pediatric research scientist and co-director of the C.S. Mott Children’s Hospital National Poll on Children’s Health.
“In many cases, there is no source that can provide an immediate, accurate, definitive diagnosis — not the [emergency department], not the child’s primary care provider, and certainly not an app,” Clark added.
Dr. James T. Eckner, director of clinical research at Michigan NeuroSport at the University of Michigan, said concussion symptoms are not specific just to concussion, so an athlete can have a headache, dizziness, or other typical concussion symptoms for reasons other than a concussion. Physicians consider a lot of information including an athlete’s history and risk factors, their mechanism of injury, the symptoms present and their time course, and objective exam findings, he said.
“Concussions need to be evaluated by a healthcare provider with appropriate expertise and using an app isn’t enough,” Eckner added. “The problem is that concussions are just too complex for an app.”
One of the dangers in using an app for a concussion is that an existing concussion could be missed and another one could occur — that could cause further brain damage.
“Those currently dealing with concussion are at increased risk for a second concussion or worsening of the initial concussion if they suffer another blow to the head, which can lead to markedly worse symptoms and significantly delayed recovery,” added Lorincz.
“When a child sustains a head injury, parents want to know if it’s a concussion,” Clark noted.
Clark recently authored that found 68 percent of parents would “definitely expect” an emergency department (ED) to tell them if their child did or did not have a concussion if they brought the child to the ED following a mild head injury. The same amount would expect the hospital to tell them how long to keep a child out of school or activities.
“So we know that parents want to have confirmation about concussion, one way or the other,” Clark told Healthline.
Making the correct diagnosis can only be done through a comprehensive neurologic evaluation by a provider with expertise in concussion care. Recovery is a complex and dynamic process, Lorincz told Healthline.
“There is no app, imaging study, or bold test that can diagnosis a concussion,” Lorincz said.
Dr. Maria Kajankova, PhD, an instructor at the Brain Injury Research Center of Mount Sinai, said healthcare professionals may incorporate evidence-based or FDA-approved concussion tests or devices as part of a diagnostic evaluation, but those things are an adjunct to an exam. They cannot be used as stand-alone tools to diagnose a brain injury or concussion.
“Parents should never attempt to diagnose a concussion or use apps or stand-alone tests to determine if their child has a concussion without an evaluation by a healthcare provider,” Kajankova told Healthline.
“Concussions can be challenging to diagnose, even for very experienced clinicians,” she said. “While it’s tempting to think an app can do this work, and objective diagnostic tools are much needed, current science doesn’t support leaving this important job to an app.”