FDA Authorizes Protective Collar for Athletes at Risk for Brain Injuries (2024)

In recent years, the potential health risks for kids who play contact sports have been in the spotlight. Now, companies are developing products to potentially protect the brain during these games.

Late last month, the U.S. Food and Drug Administration (FDA) authorized the marketing of the Q-Collar, a device worn around an athlete's neck that is supposed to help protect an athlete's brain from repetitive impacts, for athletes over the age of 13.

Research has previously indicated that children and adolescentsare more likely to sustain concussions than athletes at the collegiate level. A 2015 systematic review from the University of Calgary published in the British Journal of Sports Medicine found that athletes who played rugby, hockey, and American football experienced concussions at a higher rate than in other sports.

While the Q-collar may play a role in protecting athletes from injuries, it is not made to prevent concussions or serious brain injuries. "This is a novel device, the first of its kind for this use," Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, tells Verywell. "The clinical study data reviewed by the FDA supported the safety and effectiveness of this device as an aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts."

The FDA granted marketing authorization of the Q-Collar to Q30 Sports Science, LLC, known as Q30 Innovations. The intended price of the Q-collar in the U.S. has not been released, but in Canada, the device currently costs 250 Canadian dollars.

Potential Role of Q-Collar in Safety

The Q-Collar is considered to be a jugular vein compression collar. A 2016 study from the Cincinnati Children's Hospital published in the British Journal of Medicine looked at the role that these jugular compression collars can have in minimizing the collision of the brain against the inside of the skull, also known as slosh, among high school football players.

Studies published in the journal Frontiers in Neurology and the British Journal of Sports Medicine have also found that the Q-Collar shows promise in helping to protect adolescent athletes who play hockey and soccer, respectively.

The Q-Collar may play a role in helping people better protect themselves while playing contact sports, but it has not been tested for effectiveness on people with a range of health issues. The FDA recommends that people with certain conditions like increased pressure in the skull and known seizure disorder do not use the Q-collar.

The Q-Collar's Weak Points

While this study found that jugular vein compression collars may play a role in limiting slosh, Katherine Labiner, MD, a pediatric and sports neurologist at Child Neurology Consultants of Austin, is concerned that this may be too theoretical.

"There's no type of imaging, or kind of anything we can put inside people's skulls to know exactly what is happening [at impact]," Labiner tells Verywell. "When you read some of that information [on the Q-collar] it says 'we haven't been able to test it all, but also we assumed that it would do this, reduce the risk.'"

In their press release, the FDA wrote that one of the studies they considered when reviewing the Q-Collar for marketing approval consisted of 284 subjects 13 years or older who were participants on a high school football team.Around half wore the Q-Collar, and around half did not, and each athlete received a magnetic resonance imaging (MRI) scan pre-season and post-season.

The MRIs could indicate structural changes in the brain, but Vernon Williams, MD, sports neurologist and founding director of the Center for Sports Neurology and Pain Medicine at Cedars-Sinai Kerlan-Jobe Institute in Los Angeles, tells Verywell that issues can still arise even if it is not visible on imaging.

"What I've seen is that the Q-Collar has demonstrated a reduction in the risk of having these structural changes on imaging, but that's a different question from whether it reduces concussion or has any effect on neurologic function," Williams says.

Safer Play Is Needed

In sports like hockey and football, players already use a variety of protective gear to help them stay safe while playing sports. The Q-Collar, according to Loftus, should not replace existing helmets and other devices.

"The device was studied with users wearingthe Q-Collar withother protective sports equipment associated with specific sports activities, such as helmets and shoulder pads," Loftus says."The Q-Collar does not replace, and should be worn with, other protective sports equipment."

To create a safer environment for athletes, Williams believes that it is important to take a multifaceted approach. "If there are potential benefits from equipment, then certainly we don't want to ignore those," Williams says. "But we want to make sure that we understand them. There's also going to be benefits from changing behavior."

Part of this changing behavior also extends to making sure an athlete stops playing and gets evaluated if they show signs of a concussion, according to Labiner.

"If you go back too soon, you're at risk for not only injuring yourself further but then also prolonging your recovery," she says. "I like to remind kids, 'Would you like to miss one game now, or is it so important to go back to that one game, and particularly miss out on the rest of the season?'"

The Centers for Disease Control and Prevention outlines some important rules that people should enforce on the field tohelp reduce the risk of a concussion or other serious brain injury. These could be helpful in creating safer sports culture:

• Striking another athlete in the head
• Using their head or helmet to contact another athlete
• Making illegal contacts or checking, tackling, or colliding with an unprotected opponent
• Trying to injure or put another athlete at risk for injury