Thud. Clunk. The sounds heard across athletic fields when helmets and bodies collide make coaches, parents, fans—and especially the athletes themselves—wince. Nearly 4 million sports-related concussions occur in the United States each year, according to the Centers for Disease Control and Prevention. Football, hockey and lacrosse are sports that clearly contribute to concussion numbers, but there are many other sports, such as soccer and basketball, that also carry concussion risks.
Continuing revelations about the negative short- and long-term effects of these collisions have prompted researchers and clinicians to look for ways to treat symptoms, change field protocols and implement preventive measures.
A group of anesthesiology, neurosurgery and internal medicine doctors believe they may have an answer. Slated for release in late 2016 or early 2017, a new device worn around the neck may reduce injuries from mild traumatic brain injury (mTBI) during athletic events. The device reduces the brain’s movement inside the skull after a collision.
The rationale for the device—and the technique used to prevent injury—isn’t complex or sophisticated. In fact, it makes common sense. Just as simple changes in hand and instrument hygiene decreased infection rates in the operating room in 1846, this simple displacement of force could change the way high-impact sports play out on the field.
Germ of an Idea
The collar works by decreasing blood flow from the cranium via compression to the internal jugular veins. Intracranial pressure is not increased.
Nearly a decade ago, David Smith, MD, an internist at Reid Hospital and Health Care Services, in Richmond, Ind., thought about the way the brain rattles inside the skull during bodily collisions. Because the brain, blood and cerebrospinal fluid (CSF) don’t completely fill the volume in the skull, the “rattle effect” occurs when the brain makes contact with the walls of the cranium and tears brain fibers. In addition, Dr. Smith realized that shock waves from the collision “slosh” through the brain and cause shearing of neurons, ultimately leading to diffuse brain injury. If scientists could find a way to reduce brain compliance—a term that describes the interrelationship between the brain, blood and CSF—by increasing blood volume in the skull, for example, that might reduce the brain injury.
Dr. Smith approached Joe Fisher, MD, anesthesiology professor at the University of Toronto, anesthesiologist at University Health Network and the chief science officer at Thornhill Research Inc., in Toronto, about ways to reduce the ability of the brain to slosh inside the skull. Dr. Smith first discussed raising the pressure of carbon dioxide and increasing brain blood flow. Then Dr. Fisher realized they could achieve the same effect by decreasing the blood outflow from the cranium, which would reduce compliance but not increase intracranial pressure. Based on his work in neuroanesthesia and lumbar puncture procedures, Dr. Fisher knew firsthand about the effect of compression of internal jugular veins on CSF pressure. “During those procedures, I’d ask my nurse to put a hand under the drapes and press on the patient’s neck,” he said. “I’d see the column of CSF go up. I just knew that would work in this case.”
Drs. Fisher and Smith created a simple neckband to compress the internal jugular veins, and later designs included an opening in the front for comfort. They teamed with Julian Bailes, MD, a neurosurgeon at West Virginia University, in Morgantown, who modeled the bands on rats and ran a standard acceleration-deceleration model of mTBI. He looked for prevention of axonal injury after compression through immunohistochemical staining of amyloid precursor protein. Compression of the internal jugular vein resulted in an immediate 30% increase in intraocular and intracranial pressures in the animals. In addition, the research team had hoped for a 5% to 10% reduction in damage related to the collar, but instead found an 85% reduction, Dr. Fisher said. They published the findings in Neurosurgery (2012;70:740-746). A second study in the Journal of Neurosurgery (2012;117:1110-1118) reexamined and restained the samples for other biomarkers of brain injury. This resulted in a 48% to 59% reduction in degenerative neurons and a 36% to 45% decrease in reactive astrocytes. Furthermore, they saw a 44% to 65% reduction in microglial activation. “We couldn’t believe it,” Dr. Fisher said. “Since then, we’ve become pretty confident that it probably is that effective.”
Following the small animal study, Q30 Sports Science (now Q30 Innovations) was introduced to the research team to develop and commercialize a product. The company, a sports research and development group that focuses on reducing mTBI, licensed the technology for further research, development and global distribution. For more than three years, the company has focused on product designs and additional safety and efficacy studies with independent research institutions around the country. “mTBI is a big problem, and helmets haven’t been able to solve it,” said Tom Hoey, co-CEO of Q30. “We’re looking for solutions rooted in science. This is vital not only for athletes but also for soldiers exposed to concussive blasts.”
In 2016, Q30 is working with regulatory agencies such as the FDA, Health Canada and the European Union to approve the product. The company is also working with several football, lacrosse and hockey programs as part of its ongoing research efforts. “From the beginning,” Mr. Hoey said, “we’ve been focused on developing a novel product that would be safe and allow athletes to keep playing their sports with less concern.”
To extend the knowledge about efficacy, Q30 is funding independent research at several institutions, including Cincinnati Children’s Hospital, Mayo Clinic, Harvard Medical School and the University of Toronto. The projects investigate different aspects of slosh mitigation, using brain imaging, brain stress testing and clinical trials. “We’re committed to documenting the collar’s safety as well as its efficacy,” Mr. Hoey said. “On the efficacy side, early research is promising.”
At Cincinnati Children’s Hospital Medical Center, researchers have begun clinical trials to evaluate the collar’s safety and efficacy in humans. Greg Myer, PhD, director of research at the Human Performance Laboratory in the Sports Medicine Division, joined the research team four years ago when Dr. Smith approached him. “I’m a former football player and have sustained many injuries, which led me into sports medicine and research in this realm,” Dr. Myer said. “I thought it was a novel and innovative approach to a problem where we’re not currently finding viable solutions.”
So far in 2016, Dr. Myer’s team has submitted two manuscripts for publication. In one study, a team of hockey players was evaluated during the season through EEG imaging to measure neural networks and brain functional capacity. MRI technologies were used to evaluate white matter structure integrity after head impacts during competition. Submitted to a prominent journal in January, the positive results led to a larger study to explore the safety and efficacy of the device, Dr. Myer said.
Jeff Miller, the National Football League’s senior vice president for health and safety, admitted for the first time on March 14, 2016 that there is a direct link between football concussions and chronic traumatic encephalopathy, which leads to dementia. Mr. Miller was testifying before a U.S. House of Representatives committee when asked about the purported link, to which he replied, “The answer to that question is certainly yes.”
In the second study, 62 football players were similarly measured before the season and throughout the competitive season with MRI monitoring. The results were submitted to another journal in February. “We’re looking at positive results that are strong enough to lead to more robust clinical trials with larger cohorts,” Dr. Myer said. “The data also indicate that complementary large animal models are warranted to further validate the approach.”
As a team member of these multidisciplinary studies underway at Cincinnati Children’s Hospital, Dr. Myer is focused on the viable options for children as well. Instead of steering young athletes away from high-impact sports such as football and hockey, the research team wants to find new ways to prevent injury on the field. “We know more than we’ve ever known about concussions and brain injuries, and it’s important to keep moving forward with the scientific discoveries that come out every day,” Dr. Myer said. “We need to keep kids active. Physical inactivity is the real killer.”
In October 2015, Performance Sports Group acquired worldwide license rights to the neckband technology from Q30 to manufacture and distribute it for use by athletes. The high-performance sports equipment group is the parent company of several leading global brands such as Bauer, Mission, Maverik, Cascade, Combat and Easton. The company has focused on helmet and skull safety in recent years and followed the research work that Drs. Smith, Fisher and Bailes have conducted since 2012. “With traumatic brain injury, it’s difficult to put a preventive measure in place unless you can stop the brain from moving inside the skull,” said CEO Kevin Davis. “Without an internal device or a mechanism like this, you won’t see a significant reduction in sports-related injury.”
Performance Sports Group is working with Q30 to take the new product through the regulatory process. At the end of the process, the neckband—unlike helmets, gloves and pads—will be the first piece of sports equipment to have FDA approval. Both groups hope the device will be available for purchase in more than one country within the next year or two.
As the neckband hits the market, expect the scientific questions to continue. The product was largely made possible due to collaborative research around traumatic brain injury, the mechanisms of the slosh effect and prevention, Mr. Davis said. “We know that head injury in sports is a significant concern for parents, coaches and players,” he said. “If this device does what we think it can do, it will change sports.”