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Not So Fast, Federal Regulators Warn. There Is No Approved Device to Diagnose Concussion on the Spot

Article In Brief

Experts in mild traumatic brain injury discuss the FDA warning about unapproved devices to detect concussion marketed to the public. They agreed that proliferation of sideline tools could reintroduce ambiguity into decision-making.

As awareness of the dangers of concussion has grown, so too has interest in finding a quick and easy way to diagnose it. But the US Food and Drug Administration (FDA) warned on April 10 that parents, coaches, and others should not use devices marketed to “help assess, diagnose or manage head injury including concussion, traumatic brain injury (TBI) or mild TBI,” noting that the devices have not been reviewed by the FDA for safety and efficacy.

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. “Using such devices can result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care.”

The FDA did not name specific products or companies in the warning, but said generally that the “products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status including vision, concentration, memory, balance and speech.”

The statement said that “individuals should instead seek treatment right away from a health-care professional if any head injury, including concussion, is suspected.”

The FDA said it has alerted some companies to remove unsubstantiated claims from their products and said that it would continue to monitor the marketplace and take further action if needed. The agency noted that there are only a few medical devices that have been cleared or approved to help in the diagnosis, treatment, and management of concussion and they all require the evaluation of a healthcare professional.

It is not surprising that companies have moved to develop simple-to-use concussion diagnostic devices given how many such injuries occur each year. In the US in 2014, an estimated 812,000 children age 17 or younger were treated for concussion or TBI, whether due to a fall, sports injury or other circumstances, according to the Centers for Disease Control and Prevention. For all ages, the number was 2.8 million.

A diagnosis of concussion at the time of suspected injury is nuanced and typically made using a combination of information, including but not limited to a medical and symptom history, a neurologic exam, cognitive testing to evaluate memory, concentration and recall ability, and evaluations of balance and oculomotor function, concussion experts told Neurology Today.

Observation of the patient is also important. While the clinician may use a specific screening tool or test, such as the King-Devick Test to help detect any eye movement irregularities, no one piece of information stands alone in making a diagnosis of concussion, they said in interviews.

The appeal of portable concussion assessment devices is that they could be used at the time of suspected injury, where healthcare personnel trained in concussion and TBI may not be present, to flag individuals who need to be removed from play and get medical attention.

Among the devices in various stages of development or already in use are various mobile apps; wearable or in-office devices that track eye movement; portable devices to check electrical activity in the brain; and saliva and blood tests to check for biomarkers indicative of TBI. There has also been testing of telemedicine for concussion, like stroke telemedicine, that utilizes a sideline “robot” or smartphone or tablet device to assess potentially concussed patients in coordination with an offsite concussion expert.

Full Evaluation Needed

Experts interviewed by Neurology Today said the FDA's warning on the use of unapproved devices for concussion and other TBIs is timely and important.

Bert B. Vargas, MD, FAAN, associate professor of neurology and director of the Sports Neuroscience and Concussion Program at UT Southwestern Clinical Center, said he would be skeptical of any device that “claims to make a diagnosis of concussion in isolation, essentially taking away any thought that goes into decision making out of the hands of a qualified health care provider. I think that it is a big mistake.”

Dr. Vargas, who was part of the concussion telemedicine study, said he welcomes the development of new tools that can be used to complement clinical judgement, but “tools are really just that...they require an individual with the ability to interpret that data as a means to establish a diagnosis and treatment plan.”

Brian W. Hainline, MD, FAAN, a neurologist who is medical director of the National Collegiate Athletic Association (NCAA), said he believes that marketing is “way ahead of the science” when it comes to devices that claim to immediately diagnose or assess concussions.

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“I think that maybe within a couple of years we will have a menu of objective biomarkers and correlate those (results) with emerging sideline tools. But as for the devices marketed for the general public, my grave concern is this is going to create a false sense of safety and we really have to be careful here.”

—DR. BRIAN W. HAINLINE

“We don't have any validated sideline management tools yet,” he said. The NCAA, with funding from the U.S. Department of Defense, is tracking large numbers of collegiate athletes to better understand concussion.

“To date we have studied over 45,000 collegiate athletes and service academy cadets and tracked over 3,000 concussions,” Dr. Hainline said. The massive study is revealing how much still needs to be learned both about the biomechanics and pathophysiology of concussions, he said.

Part of the study involves the placement of head accelerometers inside the helmets of football players to determine if the frequency and magnitude of impact to the head is a predictor of concussion. Dr. Hainline said such studies are indicating that the degree of impact is not necessarily a predictor of prognosis.

“Some concussions happen at low force,” he said. The NCAA's study is collecting all sorts of data on players, including blood biomarkers and genetic information, to see if it's possible to predict who is vulnerable for concussion and whether someone is likely to have a prolonged recovery.

“I think that maybe within a couple of years we will have a menu of objective biomarkers and correlate those (results) with emerging sideline tools,” he said. “But as for the devices marketed for the general public, my grave concern is this is going to create a false sense of safety and we really have to be careful here.”

He said both false positives and false negatives could be harmful. A device “might diagnose a concussion when some other medical condition is going on,” that needs medical attention. “Or it might give a green light that says there is no concussion, when in fact there has been [one].”

Some Approved Devices Available

The FDA made clear in its warning that there are some approved devices on the market intended for use by health care professionals as part of concussion evaluation.

For instance, the agency in January approved a device called EyeBOX. Its maker, Oculogica, Inc, describes the device as “the first non-invasive baseline-free test for concussion.” EyeBox uses “eye-tracking to provide objective information to aid in the assessment of patients with suspected concussion via an easy to take four-minute test.”

In February 2018, the FDA approved the first blood test help determine whether patients with concussion and other mild traumatic brain injuries warrant further evaluation in the hospital with CT and other tests. The test, called the Brain Trauma Indicator, measures levels of two proteins, UCH-L1 and GFAP, that are released by the brain in the aftermath of injury.

Vernon B. Williams, MD, director of the Center for Sports Neurology and Pain Management at Cedars-Sinai Kerlan-Jobe Institute, said he is all in favor of new technologies that help with diagnosis and management of concussion. But he said the “appropriate tools need to be in the hands of the correct users.”

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“Tools are really just that...they require an individual with the ability to interpret that data as a means to establish a diagnosis and treatment plan.”

—DR. BERT B. VARGAS

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“Uniformly our recommendations are...if an athlete has signs and symptoms they should be removed from play. I liken it to a ‘go, no-go’ situation. It is a very straightforward decision.”

—DR. VERNON B. WILLIAMS

Growing Awareness of Concussions

Dr. Williams said there has been a lot of progress in making the public aware of the dangers of concussion and educating coaches, trainers, and players about the need to remove players from the game regardless of whether a concussion is possible, probable, or definite.

“Uniformly our recommendations are...if an athlete has signs and symptoms they should be removed from play. I liken it to a ‘go, no-go’ situation. It is a very straightforward decision,” Dr. Williams said.

He worries that a proliferation of sideline tools could reintroduce ambiguity into decision-making, especially amid the pressure to keep high-performing athletes in the game even at the youth sports level.

“Using a portable testing device to reduce that to a red light or green light in terms of making a diagnosis of concussion is a bit problematic,” Dr. Williams said.

Dr. Williams added that different sports and levels of sports may have different demands. He said that in youth and high school sports, the only error is not to take a player out of the game for any suspicion of concussion, whether that turns out to be the case or not. He said in professional boxing, on the other hand, having a portable device to that could tell if a boxer has suffered intracranial hemorrhaging could be useful.

FDA press officer Sandy Walsh said the agency did not have any reports of injuries from unapproved concussion-related device but noted that “individuals may not directly tie use of an unapproved/non-cleared device directly to an injury and therefore may not report them to FDA.”

Walsh said the agency will continue to monitor promotional material, “including materials on the Internet, products for smartphones and tablets, and claims about uses of these and similar medical devices.”

Disclosures

Dr. Vargas, Hainline, and Williams had no disclosures.

Link Up for More Information

• The FDA recommends only using cleared or approved medical devices to help assess or diagnose a head injury, including concussion: FDA safety communication. http://bit.ly/FDA-safety