The FDA has cleared a new type of device worn around the back of the neck by athletes ages 13 and up, to help protect them from brain injuries caused by typically lighter, but repeated, impacts during sports.
The Q-Collar, developed by Q30 Innovations, doesn’t replace helmets or shoulder pads, but simply compresses the veins of the neck to increase the amount of blood around the brain. This helps cushion it within the skull, from hits that may not be enough to cause concussions on their own but can add up over time.
“Today’s action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport,” said Christopher Loftus, acting director of the FDA’s neurological and physical medicine devices office.
Traumatic brain injuries can occur when a forceful impact causes the brain to slosh and move within the head, with contact during sports being a major cause.
The Centers for Disease Control and Prevention has reported increases in the number of related emergency department visits, hospitalizations and deaths, while the National Institute of Neurological Disorders and Stroke estimates that 1.6 million to 3.8 million sports- and recreation-related brain injuries occur in the U.S. each year.
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One clinical study of the Q-Collar observed players on high school football teams over the course of a season. Among students ages 13 and up, 139 wore the collar and 145 athletes did not, while all carried an accelerometer that measured the force of every impact during play. Each participant also had MRI scans taken before and after the season.
Researchers found significant changes in the deep tissues of the brain’s white matter, which help transmit nerve signals through the body. These changes were found in 73% of players who did not wear the collar—while the opposite was seen in students who did wear the device, with 77% showing no significant changes.
Over the past eight years, the Q-Collar has also been studied in hockey and soccer games, and with male and female athletes. No device-related side effects were reported, according to the company.