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Will This Device Protect Athletes’ Brains, or Only Make Them Think It Does?

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Michael Sowers, a star of the Premier Lacrosse League, endured his fifth diagnosed concussion in 2021. His personal doctor told him he might want to contemplate retiring, but one other physician had an idea that will keep him on the sphere.

Dr. Wayne Olan, a neurosurgeon at George Washington University Hospital in Washington, D.C., suggested Sowers wear a silicone collar around his neck made by an organization he serves as a medical adviser. Called Q-Collar and costing $199, the device restricts the flow of blood from the pinnacle, and, if science touted by the corporate is accepted, gives the brain an additional layer of cushioning.

“I can’t consider anything we are able to do this is so easy but in addition so vital,” Dr. Olan, who also coaches highschool lacrosse, said in an interview.

But does the Q-Collar, whose origin story involves a novel evaluation of the anatomy of a woodpecker, actually protect the brain? Football players on greater than two dozen college and N.F.L. teams are wearing it as they seek for something, anything, that may keep them protected. Still, serious doubts have emerged concerning the science behind the device, in line with an intensive review of presidency documents and scientific studies by The Recent York Times, in addition to interviews with scientists who’ve examined research into the Q-Collar.

Removed from making athletes safer, some experts in brain injuries and neuroscience say, the Q-Collar may embolden them to take risks they otherwise wouldn’t.

“The danger with a tool like that is that folks will feel more protected and play in a different way and behave in a different way,” said James Smoliga, a professor of physiology at High Point University in North Carolina who has led a crusade in academic journals against the device.

Sowers, 25, the lacrosse star, looked as if it would validate this concern. “I can go on the market and play my game,” he said. “I don’t should fear the contact.”

Q30 Innovations, the corporate that developed the Q-Collar, and experts like Dr. Olan have stood by their claims that the device could make players who wear it safer, with rule changes and safety protocols mitigating any tendencies toward recklessness.

“We’re not talking about concussions,” Tom Hoey, the corporate’s chief executive, said in an interview. “We’re talking concerning the repetitive hits,” he said, adding, “the Q-Collar reduces the injury and changes to the brain attributable to subconcussive impacts.”

Q30 Innovations, based in Westport, Conn., had a major triumph last yr when the F.D.A. approved the Q-Collar on the market as a medical device in the US.

The agency declared that company-funded studies had shown it’d limit damage to brain tissue. In November, the International Bobsleigh and Skeleton Federation approved the Q-Collar to be used in competition. Meghan Klingenberg, who plays for the Portland Thorns of the National Women’s Soccer League, wears it. So do football players at over a dozen college teams including Auburn and Alabama and 12 to fifteen N.F.L. teams. Several highschool teams have adopted the collar, too.

The device, a light-weight, cushioned collar that slips across the lower neck, is snug enough to constrict the slightest little bit of blood flow but not too tight to cause discomfort.

The everlasting damage attributable to brain injuries to athletes can have devastating effects.

Drue Tranquill, a linebacker for the Los Angeles Chargers, began wearing the Q-Collar this season. A tough hit on a punt play last yr landed him within the NF.L.’s concussion statement program.

“I desired to protect myself,” Tranquill said in a recent interview. In early October, though, the F.D.A. posted a summary of its decision that was way more measured than the February 2021 approval announcement. The summary, which the agency published to document its science, included a series of buyer beware caveats concerning the key study that led to its approval.

The agency cited uncertainty surrounding the imaging technology that the studies relied on. Those studies revealed, under certain circumstances, subtle changes within the brain tissue of highschool football and soccer players who didn’t wear the Q-Collar, no matter whether or not they experienced concussion symptoms. Those changes, detectable only with high-tech imaging, differed from changes within the brain tissue of the players who did wear it.

Nevertheless, the F.D.A. stated, a link between the changes the studies revealed and actual brain injuries has not been “validated.” Also, the agency said, the scientists found something they didn’t initially say they were in search of, potentially making the outcomes more uncertain.

“They’re finding stuff, however it appears like noise,” said Matt Tenan, a program director at West Virginia University’s Rockefeller Neuroscience Institute. He and other skeptics cite inconsistencies within the Q-Collar studies and don’t accept the idea at the guts of the device — that compressing the jugular vein within the neck keeps additional blood within the cranium, allowing the blood to operate just like the white surrounding the yolk of an egg.

The corporate points to the 18 published studies supporting the concept while also acknowledging there may be more research to be done.

At stake is a possible windfall from the greater than $30 million and countless hours of research which have already been invested in attempting to work out the efficacy of the Q-Collar. Also, though, there may be the health and safety of hundreds of thousands of athletes — pros and amateurs of all ages — and possibly soldiers who may eventually wear a tool which will provide little greater than a false sense of security.

Dr. David Smith, an inventor and former practitioner of internal medicine, got here up with the concept for the Q-Collar after discovering what he believed was the important thing to a woodpecker’s brain health — a neck muscle that contracts and traps blood of their brains after they peck, at trees, the bottom, the siding on your own home.

The idea ran counter to accepted bird research. Ornithologists have concluded that beaks and spongy skulls with unique musculature provide the cushioning, not jugular vein compression. Also, the brains of deceased woodpeckers have shown signs of brain damage.

And yet the eager for equipment that may prevent traumatic brain injury and make dangerous sports feel protected is intense.

The F.D.A. experts cited the urgent need for devices that “may” protect the brain from mild impacts in sports and the low risk of the Q-Collar.

“The probable advantages outweigh the probable risks,” the agency said.

The Q-Collar’s high-profile supporters include Dr. Julian Bailes, a NorthShore Medical Group neurosurgeon who was on the forefront of research into brain injuries in sports. Alec Baldwin portrayed Dr. Bailes within the movie “Concussion.”

Dr. Smith began his research by tossing small steel casings that held various amounts of blood from the roof of his office, however the initial small animal studies on jugular vein compression and one large animal study were performed in Dr. Bailes’s lab.

Early on, Dr. Bailes, who’s a minority shareholder in Q30 Innovations, intuited that an additional teaspoon of blood within the brain might help keep the body’s most irreplaceable organ more still.

“If the brain doesn’t move, it doesn’t get injured,” Dr. Bailes said in an interview.

Scientists skeptical of the Q-Collar accept that premise. It’s the research behind the Q-Collar that they query.

Martha Shenton is a professor of psychiatry and radiology at Harvard’s Brigham and Women’s Hospital and an authority within the high-tech brain imaging that the Q30 scientists have relied on. On the request of The Recent York Times, she reviewed the findings of the important thing study the F.D.A. cited when it approved the Q-Collar.

Dr. Shenton raved about attempting to protect the brain from contained in the skull, but was less passionate about the conclusions of the study.

“None of it is smart,” Dr. Shenton said.

Gregory Myer, director of Emory University’s Sports Performance and Research Center, who has led the Q30-funded human clinical trials, allowed that much research stays to work out the Q-Collar’s true potential.

“It will not be a magic bullet,” said Dr. Myer, who along with being the first researcher has also received money as a consultant to Q30 Innovations.

Dr. Myer said the evidence up to now suggests the collar is usually a piece of a security puzzle that features adjustments to rules.

“All of it matches together into making sports safer,” he said.

If Dr. Myer is correct, the payoff might be significant. Hoey, the Q30 chief executive, said the corporate expects $100 million in sales in the course of the next five years from just 1 percent of its goal market.

Greater than two million students in the US played highschool football, lacrosse, hockey or soccer last yr. All are considered activities with a high risk of subconcussive head impact. Hundreds of thousands more play on the youth and college level.

The corporate has spent roughly $550,000 on lobbyists and consultants to assist in its dealings with the Department of Defense.

In October, Q30 announced it had received a $2.8 million research contract from the U.S. Army to check whether the Q-Collar might help lower the danger of brain injury to soldiers exposed to explosions.

Dr. Smith first studied woodpecker anatomy some 15 years ago. He then began discussing Q-Collar prototypes with Dr. Joseph Fisher, a physiologist and expert in brain blood flow on the University of Toronto.

Together with Dr. Bailes, they spent three years constructing computer models and studying the consequences of jugular compression on pigs and rodents, eventually growing convinced the Q-Collar might be a game changer. In 2012, Dr. Bailes contacted Hoey. Q30 Innovations had been making an revolutionary, flavored mouth guard, but after speaking with Dr. Bailes the corporate decided to go all in on the Q-Collar.

“From the very starting we decided the info needed to drive the protection,” Hoey said. “We reached out to one of the best thought leaders in North America.”

In 2015, Performance Sports Group, the corporate behind several well-known sporting goods brands, akin to Bauer in hockey and Easton in baseball and softball, licensed the Q-Collar for sports uses for $7 million. It also invested $1 million in Q30 Innovations. It placed on a presentation in Midtown Manhattan for potential investors, trotting out the hockey legend Mark Messier to attest to the Q-Collar’s potential. A yr later it filed for bankruptcy.

Q30 Innovations regained full control of the device in 2018. Scientists knew by then the Q-Collar couldn’t prevent concussions. Athletes including Luke Kuechly of the Carolina Panthers had had at the least one concussion while wearing it. Dr. Myer said the corporate needed to seek out an objective measure that showed wearing the device could at the least lower the danger of brain damage.

In 2018, Dr. Myer and his team began studying 284 highschool football players on seven teams to see if scans of their brains before and after the season would reveal any differences between players who wore the Q-Collar and those that didn’t.

The players wore accelerometers inside their helmets to count the variety of hits and their impact. When the scans were combined right into a composite image for every group, they revealed, at certain levels of impact, microscopic changes in a single area of the brain for some players who didn’t wear the collars and substantially different changes for many who wore them.

Nevertheless, experts within the high tech imaging, often called D.T.I., cautioned against drawing too many conclusions based on those results.

Derek Jones, a professor at Cardiff University’s Brain Research Imaging Centre, in Wales, described D.T.I. technology as “very sensitive but not very specific.” He said the info it produces is difficult to interpret, especially within the complex regions of the brain that had produced essentially the most significant ends in the Q-Collar studies.

Dr. Shenton, the Harvard specialist, questioned the Q30 scientists’ interpretation of the info from their studies. She said the numbers reported go in the wrong way of what a brain scientist might predict, and only in a single narrow range of severity.

“They are saying, ‘We get a change and it doesn’t matter the direction,’” Dr. Shenton said. “It’s so not what you’d expect.”

Tom Talavage, head of the biomedical engineering department on the University of Cincinnati, who served because the brain imaging expert for the study, said damage to brain tissue from subconcussive hits like those who athletes involved sports experience can differ from other types of brain damage. He agreed, though, that interpreting data from this complex area of the brain may be fraught.

Dr. Myer, the first investigator on the studies, acknowledged researchers can’t yet draw any concrete conclusions.

“Hard to elucidate exactly what the outcomes mean but actually a goal for future research,” he wrote in a recent email.

Dr. Fisher, the co-inventor, said the shortage of slam-dunk proof has allowed critics to “moan and groan,” as he put it, but nobody in his family rides a motorbike or skis without wearing a collar. “Let’s say it does nothing, then you definitely lose nothing,” he said.

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