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The Food and Drug Administration recently reportedly approved a new device that could help reduce the risk of traumatic brain injury (TBI) during head impacts. The device was authorized for athletes 13 and older, and can be used during football, soccer, and other high-impact sports.
Called the Q-Collar, the device fits around the back and side of the neck and is shaped like a C. It works by clamping down on blood vessels in the neck, which increases blood volume in the skull. This limits the movement of the brain inside the skull, which researchers believe generally causes traumatic brain injury.
According to the Centers for Disease Control and Prevention (CDC), each year an estimated 1.5 million people in the U.S. sustain a TBI. Moreover, it is a leading cause of death and disability among children and young adults in the country. Of those hospitalized for this type of injury, 230,000 survive, 50,000 die, and 80,000 to 90,000 people experience the onset of long-term disability. Moreover, the risk of TBI among men is twice the risk among women, and the major causes of them are car accidents, falls, violence, and sports.
The 5th International Conference on Concussion in Sport held in Berlin, Germany, in 2016 defined sport-related concussions as the historical term representing low velocity injuries that cause brain “shaking,” resulting in clinical symptoms and that are not necessarily related to a pathological injury. They may be caused either by a direct blow to the head, face, neck or elsewhere on the body with an “impulsive” force transmitted to the head.
Per the American Association of Neurological Surgeons, amongst U.S. children and teens, sports and recreational activities contribute to over 21% of all TBIs. Sustaining an injury while playing sports can range from a mild physical trauma such as a scalp contusion or laceration to severe TBI with concurrent bleeding in the brain or coma.
The FDA said it based its recommendation on a number of studies, including one that compared changes in brain structure between high school football players who wore the Q-Collar versus those who did not. All participants were 13 years and older. The researchers reportedly used advanced imaging techniques to look at changes in the brains of nearly 300 study participants before and after the season. They found changes in deep structures of the brain in 73% of participants in the no-collar group, while no significant changes in these same structures were found in 77% of participants in the collar group.
Dr. Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health reportedly said: “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.”
However, the FDA also noted that the data provided for the Q-Collar did not demonstrate that the device prevents concussion or serious head injury. The agency also added that the Q-Collar should not replace other protective equipment associated with sports activities.
During his final seasons with the NFL, Carolina Panthers’ Linebacker Luke Kuechly was reportedly seen wearing the Q-Collar before retiring at 28 after suffering a series of head injuries.