Not all bumps on the head do significant damage, but there is growing concerned about the safety and long-term impacts of hard hits to the head, concussions, and traumatic brain injury — especially in sports. So what can athletes do to protect themselves from the threat of head injury? One company claims their device can help.
Some bumps, blows, or jolts to the head can cause traumatic brain injury.
Traumatic brain injuries can disrupt normal brain function and have short and long-term impacts on a person’s life.
The Q-Collar is an FDA-approved device that may help protect the brain from the effects of some head impacts.
The Q-Collar may reduce the occurrence of specific changes in the brain that are associated with brain injury.
Data do not show that the Q-Collar can prevent concussion or serious head injury.
Public health experts are becoming more aware of the potentially dangerous, long-term impacts of traumatic brain injury (TBI), even in mild cases. According to existing data, more than 1.5 million Americans yearly experience a TBI.
In 2021, the U.S. Food and Drug Administration (FDA) authorized the marketing and sale of a new device that athletes can wear to help protect their brains during high-impact activities. The Q-Collar is the only FDA-cleared device to reduce TBI.
Brain injury is a public health concern
According to the Centers for Disease Control (CDC), some bumps, blows, or jolts to the head can cause TBI. A hit to the body that causes the head and brain to move back and forth can also cause a TBI.
Traumatic brain injuries can range from mild to severe — a concussion is one example of a mild TBI.
Traumatic brain injuries can disrupt normal brain function. These changes in brain function can significantly impact a person, affecting how they think, act, feel, learn, and sleep.
Depending on the severity of the injury, people with a TBI could face health problems for a few days — or the rest of their lives.
The number of TBIs is rising
Traumatic brain injuries are on the rise. The number of TBI-related emergency department visits, hospitalizations, and deaths increased by 53 percent between 2006 and 2014.
In 2020, there were more than 64,000 TBI-related deaths in the United States.
In the U.S., TBI in children is a significant public health problem, according to the CDC.
What is a Q-Collar?
A Q-Collar is a non-invasive device that people aged 13 and older can wear around their neck during athletic activity to help protect the brain.
Q30 Innovations developed the C-shaped collar to protect against mild TBI.
The device is used to help protect the brain from the effects of blows to the head that don’t cause symptoms — also known as repetitive subconcussive head impacts.
However, according to the FDA, data and research do not show that the Q-Collar can prevent concussion or serious head injury.
How does the Q-Collar work?
According to the FDA, the Q-Collar may reduce the occurrence of specific changes in the brain that are associated with brain injury.
“The Q-Collar is a non-invasive device worn around the neck that applies mild pressure to the internal jugular veins, which allows for a backfilling of fluid in the brain,” said Tom Hoey, Co-CEO of Q30 Innovations. “This reduces its ability to move around or slosh inside the head, which is the primary cause of brain injury. The Q-Collar helps reduce injury caused by repetitive, subconcussive impacts.”
By reducing the movement of the brain within the cranial space, the Q-Collar may help protect the brain from the effects of head impacts.
Many athletes are wearing the device
In December 2022, New York City FC used their first-round pick to select midfielder Malcolm Johnston in the Major League Soccer SuperDraft. Johnston is considered one of the country's top soccer prospects. He’s also a Q-Collar ambassador. Johnston wears the device to protect his brain, hopefully ensuring a long and healthy life beyond soccer.
"It's very important to protect myself when playing an impact sport because it helps me focus on the game itself rather than worrying about the health of my brain. This is especially apparent after having a significant concussion in my soccer career. The Q-Collar feels comfortable on my neck, and it isn’t noticeable when I’m playing. It gives me a sense of stability when I’m on the field in competition."Malcolm Johnston, New York City FC midfielder and Q-Collar ambassador
Chris Rindov is another soccer player who is thinking long term — and a Q-Collar ambassador.
Rindov has been playing soccer since he was three years old and was selected by Sporting Kansas City in the MLS SuperDraft. He wears the device during competition and is also a Q-Collar ambassador.
"I want to prolong my career as long as possible while staying as safe as possible. I play center defender, so heading the ball is a huge part of my game and having that added protection is important to me. I know that I will need my brain forever, so having that added protection will be beneficial to me in the long run. It is practically unnoticeable when I play. I would compare it to a shin guard in terms of the fact that you don’t feel it when you play."Chris Rindov, Sporting Kansas City defenseman
While Q30 Innovations indicates there is medically no “break-in” period, Rindov said he went through a slight adjustment period to wearing the device. He suggested that users do a light activity before wearing the device during a training session, practice, or competition.
“Each athlete takes to it differently, and we recommend training or working out with the Q-Collar on before wearing it in competition to get used to how it feels,” said Hoey.
Is the Q-Collar effective?
The FDA reviewed the device through a regulatory pathway for low-to-moderate-risk devices of a new type. This is called a De Novo premarket review pathway.
The FDA assessed the safety and effectiveness of the Q-Collar through multiple studies, including pilot studies and clinical trials. You can read about the studies and the findings in the De Novo Classification Request.
“Our researchers focused on using advanced imaging to objectively determine whether the Q-Collar protects the brain,” said Hoey. “According to the FDA’s analysis, athletes who did not wear the Q-Collar are three times more likely to have significant changes in their brains following a season of football than those who wore the Q-Collar.”
Q-Collar critics say the research is flawed
Critics of the Q-Collar say the research to justify the Q-collar is highly flawed.
James Smoliga is a professor in the Department of Physical Therapy at High Point University. He has a Doctorate of Philosophy (Ph.D.) in Sports Medicine, is a Fellow of the American College of Sports Medicine, and has published over 75 peer-review publications in scientific and medical journals.
"I feel that the research behind the Q-Collar is highly flawed and the marketing claims are not accurate– [as] they are oversimplifications and exaggerations of peer-review research, and that research appears to have numerous inconsistencies, methodological fallacies, bias, and potentially even some ethical issues."James Smoliga, DVM, Ph.D., FACSM
Smoliga points to limitations listed by the FDA in the De Novo Classification Request that include the following:
- The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated.
- The use of imaging studies as a future indicator of brain injury has not been validated.
- Data do not demonstrate that the device can prevent concussion or serious brain injury.
Smoliga wants stakeholders in the sports community to be able to make informed decisions.
As a critic of the Q-collar, Smoliga said, "fear over long-term brain health has created a whole market of products, which are being sold to a vulnerable population. However, in my opinion, the product doesn’t work.”
In response to critics, Q30 Innovations understands there will be disagreement and encourages healthy debate.
“We are proud of the results of the independent research and the product that we have developed,” said Hoey. “We invested a lot of time, money, and resources into ensuring this device were not only safe to use, but effectively helps protect the brain before putting it on the market.”
Weighing the risks and benefits
According to the FDA, no significant adverse events were associated with device use.
"The Q-Collar is a safe and effective piece of equipment to help protect the brain that was subject to eight years of thorough evaluation. All of the research has also proven that there is virtually no risk to wearing the Q-Collar."Tom Hoey, Co-CEO of Q30 Innovations.
In the FDA’s Q-Collar De Novo Classification Request document, the entity states there could be risks to a user's health if precautions are not taken.
The risks stated include injury from excessive head impacts caused by:
- Athletes using the device who should not be allowed to.
- Potential device interference with existing protective equipment.
- A potential false sense of protection.
Smoliga is concerned about the potential risk-compensation.
“It may help players to feel more protected, and parents to perceive that risks are lower — but I do not believe the device can have any beneficial effect on protecting the brain in any way [and] as such, it allows players to continue to be exposed to potentially damaging impacts, but think that they are safe,” said Smoliga. “This may cause them to play differently or feel differently.”
What Q-Collar users should know
Athletes deciding to wear the Q-Collar to protect against TBI should know how to use the product — and understand its limitations. The manufacturer and the FDA have provided additional guidelines and information.
- The Q-Collar does not replace other protective equipment.
- The Q-Collar should be worn with other protective sports equipment associated with specific sports activities, like helmets and shoulder pads.
- Wearers of the device should not depend on the device to protect them from all harmful effects of head impacts.
- Users should take steps to avoid direct impact to the head and neck.
- The Q-Collar should not be used if an individual has not been medically cleared to play contact sports.
- The device can be worn for up to four hours at a time and should be replaced after two years of active use or upon the product’s expiration date listed on the package.
- Q30 Innovations offers discounts for military, government employees, first responders, teachers, and students through the website ID.Me.
- The device is FSA/HSA-eligible.
Although the manufacturer and experts may disagree on the effectiveness of the Q-Collar, many athletes believe in its ability to protect the brain.