While some regard the FDA-authorised Q-Collar as a revolutionary brain injury prevention tool for athletes, some scientists are sceptical about its true efficacy. NR Times reports.
A growing number of professional athletes, mostly American football players, have been seen wearing a novel device around the neck. It is said to reduce the risk of head trauma in contact sports, but the device has stirred up controversy as sceptical scientists call into question the theories behind the technology.
According to the Centres for Disease Control and Prevention, from 2006 to 2014, the number of TBI-related emergency department visits, hospitalisations and deaths in the US increased by 53 per cent.
Over time, repeated knocks to the head – even those that do not cause a concussion – can lead to a serious condition known as chronic traumatic encephalopathy (CTE).
It was originally described as “punch-drunk syndrome” when it was first identified in boxers in the 1920s.
It wasn’t until 2002 that it received wider spread recognition when neuropathologist Bennet Omalu diagnosed the American footballer Mike Webster with CTE after his death.
Webster died after a period of erratic and unexplained behaviour which an autopsy linked to brain damage that appeared similar to that seen in late-stage Alzheimer’s patients.
With greater awareness of conditions like CTE, the demand for new methods and technologies to prevent sports-related brain injury has never been greater.
So, when a new device called the Q-Collar emerged claiming to protect the brain of American footballers and other athletes, it received widespread attention from the sporting community.
The device, which fits around the neck, works by preventing “brain slosh”, a term coined by the inventor of the Q-Collar, Dr David Smith, who is now a medical adviser to Q30 Innovations, the company that markets the device.
He proposed that when people experience blunt trauma accidents the brain moves unrestrained in the skull, in other words, “slosh”.
The device has a number of high-profile proponents, including neurosurgeon Dr Julian Bailles, who acts as Q-Collar’s chief medical advisor and chairman of the department of neurosurgery at the NorthShore neurological institute. Dr Bailles was involved in identifying the first evidence of CTE and is depicted by Alec Baldwin in the 2016 film Concussion.
“Some of the important cases of CTE were [people] who had been playing American football for 30 years and never had a diagnosed concussion,” Dr Bailles told NR Times. “But they had a breakdown of tau proteins and others in multiple areas of the brain that indicated that these repetitive, even sub-concussive hits, can accrue with time.”
The Q-Collar is built on the concept of jugular compression, whereby a small amount of pressure is applied on the vein to limit the flow of blood leaving the head. Q30 Innovations claims these additional two to three tablespoons of blood can prevent “slosh”.
“We know that the cranium has a lot of fluid in it,” Dr Bailles explained. “It has blood, it has cerebral spinal fluid, it has interstitial fluid and fluid between cells. It’s a lot of fluid which we believe would behave consistently with the laws of physics.
“With every heartbeat, about 20 to 25 per cent of your cardiac output goes to the brain. That means in every second of your life, that amount of blood has to be returned to the heart.
“If we have a partial restriction of blood flow from the jugular back to the heart, it increases the amount of blood somewhat – not by much – in the cranium.”
“Two to three tablespoons is enough to fill up what we call the venous capacitance vessels that have the ability to flex up and contain a little more fluid, and we believe that reduces the brain’s ability to move inside the skull when it’s struck.”
In February 2021, the FDA granted the Q-Collar market authorisation. In its announcement, the FDA said it had assessed the safety and effectiveness of the Q-Collar through several studies, including a prospective, longitudinal study in the United States with 284 teenage participants on a high school football team.
During the sports season, 139 athletes wore the Q-Collar and 145 athletes did not.
They all wore an accelerometer device that measured every impact to the head sustained during play, and each athlete underwent an MRI scan pre-season and post-season.
The study found that in the no-collar group, significant changes were found in 73 per cent of participants, specifically in white matter regions of the brain – deep tissues involved in the transmission of electrical nerve signals.
In the group wearing the collar, 77 per cent experienced no significant changes in these regions.
The FDA said these differences appeared to indicate protection of the brain when using the device.
No significant adverse events were associated with device use.
The results looked promising, but a document published by the FDA later in the year raised several uncertainties, including a list of warnings and precautions.
One caveat stated that “the use of imaging studies as a future indicator of brain injury has not been validated”.
Elsewhere, the summary stated the Q-Collar had not “demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated”.
Among the device’s most vocal critics is James Smoglia, a professor of physiology at High Point University in North Carolina.
Professor Smoglia and his colleagues have published several papers calling into question the theories that the Q-Collar technology was based on.
One of his arguments calls into question research published in 2014 which proposed that American footballers who played at higher altitudes were 20-30 per cent less likely to receive a concussion due to swelling of the brain caused by higher altitudes.
The tighter fit of the brain in the head reduced slosh, the authors proposed.
They also proposed that a device which applied pressure to the jugular vein could trap blood in the cranium and therefore replicate the brain-swelling effects of high altitude. One of the paper’s authors was Q-Collar inventor Dr David Smith who a few years earlier had filed a patent for a device that would later become the Q-Collar.
A Twitter thread from Professor Smoglia dating to 2019 pointed out that no conflict of interest was declared in the paper. In an opinion piece published in The Conversation, Smoglia also questioned the science behind the paper.
“While those less familiar with physiology may have been persuaded by this fascinating-sounding explanation, my fellow researcher, Gerald Zavorsky, and I thought this idea was scientifically implausible,” Smoglia wrote.
The two scientists published a paper arguing that the link between altitude and brain injury was one of chance.
They discovered that a 20-30 per cent reduced risk of brain injury was also the case for teams with animal logos.
In addition, the pair discovered that while a link was found in the 2013 season, there was no connection between higher altitudes and concussions in 2012, 2014 or 2015.
Writing in The Conversations, Smoglia added: “Based on our analysis, we concluded that random chance, not physiological response, explains why concussions were less likely at altitudes above 600 feet. Thus, an altitude-mimicking collar seems unjustified for preventing concussions.”
One of professor Smoglia’s other arguments, which is echoed by other critics, is that the Q-Collar may give athletes a false sense of security, especially when more research is needed to confirm the device’s efficacy.
Q30 Innovations asserts that the Q Collar is not marketed to prevent concussion but rather protects against sub-concussive impacts, which over time, can lead to serious complications, such as CTE, later in life.
“The [Q-Collar] is trying to prevent or reduce the effects of repetitive head impact. That was the basis of the FDA’s approach to clearing the device as a class two medical device in the US.”
Dr Bailles “strongly refutes” criticisms of the device and cites the football helmet as the “greatest example” of a false sense of security.
“The helmet is the best example of that,” he said. “It has been that way for decades. The helmet has encouraged many players in various sports to stick their heads in there and hit head to head but the helmet can’t stop the brain from moving around.”
