What Is The Reality Of The Device Which Claims To Protect Athletes From Brain Injury: The Premier Lacrosse League’s Michael Sowers, a star player, suffered his fifth concussion in 2021. His primary care physician advised him to think about retiring, but a different doctor offered a suggestion that would keep him in the game.
Sowers was advised to wear a silicone collar created by a business for which Dr. Wayne Olan, a neurosurgeon at George Washington University Hospital in Washington, D.C., serves as a medical advisor. The $199 Q-Collar gadget limits blood flow from the head and, if the company’s science claims are true, provides the brain with an additional layer of padding.
Dr. Olan, who also coaches high school lacrosse, said in an interview, “I can’t think of anything we can do that is so simple but also so vital.”
But does the Q-Collar, whose history includes an original analysis of a woodpecker’s structure, genuinely shield the brain? It is being worn by football players on more than a dozen college and NFL teams as they look for anything—anything—that can keep them safe. Nevertheless, a thorough analysis of government records and academic studies by The New York Times, as well as conversations with academics who have looked into research into the Q-Collar, have raised severe concerns about the device’s scientific foundation.
The Q-Collar may encourage athletes to take risks they otherwise wouldn’t, according to some experts in brain trauma and neurology, rather than making them safer.
“The problem with a gadget like this is that individuals will feel more protected and play differently and behave differently,” said James Smoliga, a professor of physiology at High Point University in North Carolina who has led a battle in academic publications against the device.
The 25-year-old lacrosse star Sowers appeared to support this worry. He answered, “I can go out there and play my game.” I need not be afraid of making contact.
The manufacturer of the Q-Collar, Q30 Innovations, and authorities like Dr. Olan stand by their assertions that the device can make players who wear it safer by reducing any propensities for recklessness through rule changes and safety practices.
The company’s chief executive, Tom Hoey, stated in an interview that “we’re not talking about concussions.” We’re talking about repetitive strikes, he continued, adding that the Q-Collar lessens the damage and alterations to the brain brought on by such impacts.
When the F.D.A. certified the Q-Collar for sale as a medical device in the United States last year, Westport, Connecticut-based Q30 Innovations experienced a big victory.
According to the agency, studies sponsored by the corporation had suggested that it might prevent brain tissue damage. The International Bobsleigh and Skeleton Federation authorized the use of the Q-Collar in competition in November. It is worn by Meghan Klingenberg, a National Women’s Soccer League player with the Portland Thorns. Additionally, football players from 12 to 15 N.F.L. teams and more than a dozen college teams, including Auburn and Alabama, agree. Many high school teams have also started using collars.
The device, a soft, lightweight collar that fits around the lower neck, is snug enough to restrict just a tiny amount of blood flow but is not uncomfortable.
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This season, Los Angeles Chargers linebacker Drue Tranquill began donning the Q-Collar. Last year, a brutal hit on a punt play put him in the National Football League’s concussion observation program.
In a recent interview, Tranquill stated, “I wanted to defend myself. However, the FDA published a summary of its conclusion in early October that was much soberer than the announcement of the clearance in February 2021. The summary, which the government released to support its science, contained a number of buyers’ beware cautions regarding the important study that served as the basis for its clearance.
The agency cited the studies’ reliance on imaging technologies as being unclear. These investigations showed that high school football and soccer players who did not use the Q-Collar under specific conditions showed minor alterations in their brain tissue, regardless of whether they displayed concussion symptoms.
These differences from alterations in the brain tissue of the athletes who did wear it were only visible with advanced imaging techniques.
The F.D.A. claimed that no connection had been “validated” between the changes the research discovered an actual brain damage. The scientists discovered something they had not initially claimed to be looking for, according to the government, thereby increasing the uncertainty of the findings.
According to Matt Tenan, director of the Rockefeller Neuroscience Institute at West Virginia University, “They’re finding stuff, but it feels like noise.” He and other skeptics point to contradictions in the Q-Collar studies and contest the device’s central tenet: that by squeezing the jugular vein in the neck, more blood is contained in the head, mimicking the way the yolk of an egg is surrounded by the white.
The business cites the 18 published studies that back the theory while also admitting that more study has to be done.
A possible profit from the more than $30 million and countless hours of research already devoted to determining the effectiveness of the Q-Collar are at risk. The health and safety of millions of athletes, both professional and amateur, of all ages, as well as potential soldiers, who could one day wear a gadget that might only offer a false sense of security, must also be considered.
The biggest names in brains and an intriguing genesis tale.
After learning what he thought to be the secret to a woodpecker’s brain health — a neck muscle that contracts and traps blood in their brains when they peck, at trees, the ground, or the siding on your house — inventor and former internal medicine doctor Dr. David Smith came up with the idea for the Q-Collar.
The notion went against current knowledge about birds. Rather than jugular vein compression, ornithologists have found that beaks and spongy skulls with distinctive musculature provide cushioning. Additionally, dead woodpeckers’ brains had evidence of brain injury.
Yet there is a strong desire for apparatus that can shield users from traumatic brain injury and make risky activities feel secure.
The F.D.A. specialists underlined the urgent need for gadgets that “may” shield the brain from minor sports-related damages as well as the Q-low Collar’s risk.
Among the prominent backers of the Q-Collar is Dr. Julian Bailes, a neurosurgeon of the NorthShore Medical Group who was a pioneer in the study of brain injuries in sports. Dr. Bailes was represented by Alec Baldwin in the film “Concussion.”
The early small animal tests on jugular vein compression and one big animal study were carried out in Dr. Bailes’ lab. Dr. Smith started his research by throwing small steel casings with varied volumes of blood from the roof of his office.
Early on, Dr. Bailes, a Q30 Innovations minority shareholder, had the idea that adding an extra teaspoon of blood to the brain might help it stay calmer.
According to Dr. Bailes, if the brain is immobile, no damage may occur.
That assumption is made by scientists who are skeptical of the Q-Collar. They have concerns about the Q-study. Collar’s
Professor of radiology and psychiatry at Harvard’s Brigham and Women’s Hospital, Martha Shenton is a specialist in the cutting-edge brain imaging techniques that the Q30 researchers have used. She looked at the results of the important study that the F.D.A. cited in approving the Q-Collar at The New York Times’ request.
Dr. Shenton gushed about the need to safeguard the brain from within the skull, but he was less enthused about the study’s findings.
None of it makes sense, according to Dr. Shenton.
Gregory Myer, director of Emory University’s Sports Performance and Research Center, who oversaw the human clinical trials funded by Q30, acknowledged that there is still much work to be done to fully understand the Q-capabilities. Collar’s
Dr. Myer, who served as the lead researcher and also accepted payment as a consultant to Q30 Innovations, declared that “it is not a magic bullet.”
According to Dr. Myer, the evidence thus far points to the collar as a potential component of a safety solution that also requires changes to the law.
All of it works together to make sports safer, he claimed.
If Dr. Myer is correct, there could be a sizable reward. Hoey, the Q30 chief executive, said the company expects $100 million in revenues within the next five years from just 1 percent of its target market.
In the past year, more than two million children in the US participated in high school football, lacrosse, hockey, or soccer. All of these are regarded as having a significant risk of subconcussive head impact. Many more people participate in youth and collegiate sports.
To assist in its dealings with the Department of Defense, the firm has spent about $550,000 on lobbyists and consultants.
The U.S. Army awarded Q30 a $2.8 million research contract in October to investigate if the Q-Collar might help soldiers exposed to explosives reduce their risk of brain damage.
A crucial study receives both questions and permission.
About 15 years ago, Dr. Smith began researching the anatomy of woodpeckers. He then started talking about Q-Collar prototypes with Dr. Joseph Fisher, a University of Toronto physiologist and authority on brain blood flow.
Together with Dr. Bailes, they worked on creating computer simulations and researching the effects of jugular compression on rats and pigs for three years before coming to the conclusion that the Q-Collar would be a game-changer. Dr. Bailes got in touch with Hoey in 2012. After discussing with Dr. Bailes, Q30 Innovations opted to focus only on the Q-Collar rather than continuing to develop its novel, flavor-infused mouthguard.
“We determined the data had to drive the safety from the very beginning,” Hoey added. “We contacted the top North American thought leaders,”
The Q-Collar was licensed for use in sports by Performance Sports Group in 2015 for $7 million. Performance Sports Group is the organization behind several well-known sporting goods brands, including Bauer in hockey and Easton in baseball and softball. Furthermore, it contributed $1 million to Q30 Innovations.
It put on a presentation for possible investors in Midtown Manhattan and brought out hockey great Mark Messier to speak about the possibilities of the Q-Collar. It made a bankruptcy filing a year later.
In 2018, Q30 Innovations reclaimed total command of the apparatus. Scientists at the time understood the Q-Collar could not shield users from head injuries. It has been worn by athletes who have suffered at least one concussion, including Luke Kuechly of the Carolina Panthers.
According to Dr. Myer, the business wanted to discover an objective metric demonstrating that using the gadget may, at the very least, reduce the chance of brain damage.
In order to determine whether brain scans taken before and after the season would show any changes between players who wore the Q-Collar and those who did not, Dr. Myer and his team started researching 284 high school football players on seven teams in 2018.
To track the number of hits and their impact, the players wore accelerometers inside their helmets. At certain levels of impact, the scans merged into a composite image for each group showed microscopic changes in one region of the brain for certain players who did not wear the collars and noticeably distinct changes for those who did.
D.T.I. professionals, who specialize in high-tech imaging, issued a warning against making too many assumptions based on their findings.
The Brain Research Imaging Center at Cardiff University in Wales professor Derek Jones called D.T.I. technology “extremely sensitive but not particularly specific.” He claimed that the data it generates is challenging to analyze, particularly in the intricate brain regions that gave rise to the most notable findings in the Q-Collar research.
The Harvard expert, Dr. Shenton, questioned how the Q30 researchers were interpreting the results from their investigations. She said that only in one specific range of severity did the reported figures deviate from what a brain scientist may have predicted.
They claim that it doesn’t matter which direction the alteration takes after it occurs. It’s completely contrary to what you would anticipate.
According to Tom Talavage, head of the biomedical engineering department at the University of Cincinnati and the study’s expert on brain imaging, damage to brain tissue caused by subconcussive hits, such as those experienced by athletes in contact sports, can be distinguished from other types of brain damage. He acknowledged that it can be challenging to understand data from this intricate region of the brain, though.
Dr. Myer, the study’s principal investigator, noted that no firm conclusions have yet been reached.
He recently stated in an email that it was “hard to describe exactly what the data signify but obviously a topic for future investigation.”
The co-inventor, Dr. Fisher, claimed that the absence of irrefutable evidence has given skeptics room to “moan and sigh,” as he called it, but no one in his family goes biking or skiing without a collar. If it doesn’t do anything, you won’t lose anything, he said.