Diagnosing Concussions and Assessing Balance- On Your iPhone

The fall sports season is tantalizingly near; players and fans alike are gearing up for the Friday night lights and Sunday afternoon showdowns. But the season comes at a cost; every bone-jarring hit and wince-inducing header carries the risk of sustaining a concussion.

Most media coverage focuses on the National Football League’s professional players, but 65% of traumatic brain injuries are sustained by children. The majority are thought to be undiagnosed, but the Center for Disease Control estimates that 1.6 to 3.8 million sports-related concussions occur each year. This puts athletes at risk of sustaining a second concussion before their brains are fully healed, leading to longer recoveries, permanent neurological damage, and the potentially-fatal Second Impact Syndrome.

A just-released app hopes to change that. Sway Medical, founded by Chase Curtiss in 2011, aims to help health professionals objectively rate the risk of concussion at the source: on the football field or soccer pitch. On-the-spot concussion diagnosis is just the beginning, though; in the near future, the young company plans to enter the hospital space by the end of the year.

The FDA-approved app, called Sway Balance, uses proprietary software and the iPhone’s accelerometer to assess an athlete’s balance over time. In a phone interview, founder and CEO Chase Curtiss said that the app can be used by a health professional to “set up a baseline,” then “compare an athlete over the course of a season to that established norm.” Poor performance compared to baseline is indicative of a possible concussion.

Health care professionals can purchase a yearly subscription to the app for $199 – a fraction of the cost of a typical balance platform – and the patient-facing app is free to download.

Sway Medical has partnered with ImPACT Applications, an organization which Curtiss described as conducting the “gold standard of concussion testing on the market.” ImPACT uses baseline cognitive testing – verbal and visual memory, processing speed, and reaction time – and synchronous testing immediately after a hit to assess if a concussion has occurred.

“But you don’t have an element of physical control of the body,” Curtiss said – which is where Sway Balance comes in. “[ImPACT’s] interest in us is in pairing a balance test with cognitive testing.”

Dr. Andrew Blecher, a sports medicine physician and certified ImPACT consultant, stressed in an interview that “the diagnosis of concussion is very subjective” but that “more information is a good thing.”

Curtiss noted that Sway Balance merely adds one more objective piece of information. “We have this tool to be able to have a quantitative number to say, yes, here’s their score now, here’s how it compares to before,” Curtiss said. “That’s really the value of our tool is objectifying that, to have a real score.”

Blecher is sanguine about Sway Medical’s partnership with ImPACT. “I think Sway in and of itself is, is you know, maybe a hit-or-miss type thing, but partnered with ImPACT, it’s kind of a home run,” Blecher said. “The partnership between the two is really big.”

Dr. John Schumann, a general internist and medical educator at the University of Oklahoma School of Community Medicine, agreed. “Something like that has the potential anyway of becoming the standard of care…. We can use this as an objective criteria to judge his balance and his or her abilities.

Off the Field, Into the Ward

But the application was cleared by the FDA to do much more than on-the-field concussion testing. “Our indications of use are [as] a prescriptive device [used] by a… qualified health professional… and it’s prescribable for the assessment of balance as a symptom of head injury, fatigue, nausea, orthopedic injury, and medication use,” Curtiss said. “It was a pretty broad issuance from an indication standpoint.”

That broad issuance opens the door for balance assessment and testing at the point of care, and allows Sway’s use in a variety of contexts, like post-surgical assessment and falls prevention.

Sway Medical’s entry point into the hospital market will be the orthopedic ward, used by physicians and physical therapists to assess a patient’s balance after a hip or knee replacement. It hopes to start there by the end of the year.

In an outcomes-based reimbursement model, objective measurements become critically important. “That’s where we think our objective assessment tools can help more rigidly establish what those numbers are,” Curtiss said. “Hopefully [we will] help kind of push that pay-for-performance metric based on objective scores.”

Another potential use of the app is to assess the falls risk for elderly patients or residents of nursing homes. Between 700,000 and 1,000,000 patients fall in hospitals each year, costing billions of (often non-reimbursable) dollars; one-third are thought to be preventable. The app could be used by physical therapists or physicians to assess a patient’s balance frequently, with lower-than-baseline scores triggering increased attention and fall risk precautions.

Balancing Efficacy and Reimbursement

“I think what has to be looked at is, how do we fit in the health care system now and how do we fit into the healthcare system of the future?” Curtiss said. “Our company is really focused on ‘how do we do both of those?’”

Sway Medical’s goal is to amplify existing physician and physical therapist behaviors rather than modify current practice wholesale. “[Our app] is a structured balance test like [physicians] have been doing their entire careers that is much more objectively and clinically valid than the subjective tests they’ve been relying on,” Curtiss said.  “We really think that our tool should be much better at creating more time efficient and more data-supported decisions of the physician.”

Dr. Blecher isn’t as optimistic about the app’s use in a hospital setting. “I don’t know how much people will be using it in a hospital setting. Maybe they would. I don’t know,” he said.

Partly, this is because of the alternatives hospital-based clinicians have. “The sidelines don’t have a lot of tools that are quickly, readily available; in the hospital there are a lot of tools that are available,” he added. Physicians and physical therapists will have to choose Sway Balance over alternatives they understand, already use, and trust.

Whether Sway Balance is used in the hospital setting will likely hinge on future studies investigating its efficacy compared to these other tools. If it’s as effective and easier to use, physicians and physical therapists will migrate to it over time.

Critically, reimbursement concerns will not be part of clinicians’ hesitancy to use the app: it’s reimbursable by Medicare and other insurers. This mitigates one of the most salient risks healthcare innovators face: getting too far ahead of the system’s ability to pay for their innovations.

As the American health care system moves away from fee-for-service reimbursement to an outcomes-based model, Sway Medical’s success will rely more on its efficacy than its ability to be reimbursed. If it succeeds in pleasing health care professionals, reducing the likelihood of dangerous concurrent concussions, and preventing falls, the company will likely see success.

Mike Miesen is a former hospital operations consultant and current freelance journalist, covering American health policy and international development from east Africa. Follow him on Twitter @MikeMiesen.