Feb. 26, 2021 -- The FDA has cleared a new over-the-counter device designed to protect children aged 13 years and older from sports-related traumatic brain injury.

The agency approved the noninvasive device, called Q-Collar (Q30 Sports Science, LLC), a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain, which may occur because of hits to the head. The device may reduce specific changes in the brain that are associated with brain injury.

"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," 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, said in a statement.

CDC data shows that from 2006 to 2014, the number of traumatic brain-related emergency department visits, hospitalizations, and deaths increased 53%.

In addition, the FDA says that blunt trauma accidents, or accidents that involve being hit by or against an object, particularly when playing sports, are a major cause of TBI. The National Institute of Neurological Disorders and Stroke estimates that up to 3.8 million sports- and recreation-related traumatic brain injuries happen in the United States each year.

The Q-Collar provides compressive force to the internal jugular veins, which increases the blood volume in the skull's blood vessels. Blunt trauma accidents cause the brain to move, when not restrained, in the skull. An increase in blood volume in those blood vessels causes the brain to fit more tightly inside the skull, which reduces this "slosh" movement. By reducing the movement of the brain within the skull, the Q-Collar may help protect the brain from the effects of head impacts.

The FDA's approval of the device is based on evidence from several studies, including one in the United States that involved 284 persons aged 13 years or older who were participants on high school football teams.

During the sports season, 139 athletes wore the Q-Collar, and 145 athletes did not. All participants also wore an accelerometer that measured every impact to the head sustained during play. Each athlete underwent an MRI before the sports season and after. These MRI scans were used to create an image of the brain that allowed researchers to compare structural changes in the participants' brain after a season of play.

Significant changes were found in deeper tissues of the brain involved in 106 of the 145 (73%) participants in the no-Q-Collar group; no significant changes were found in these regions in 107 of the 139 (77%) players who wore the Q Collar, the FDA reports.

These differences appear to indicate that the device protected the brain. No significant adverse events were associated with use of the device.

The FDA cautions that the Q-Collar does not replace, and should be worn with, other protective sports equipment associated with specific sports activities, including helmets and shoulder pads. It also notes that the device does not protect from all harmful effects of hits to the head or from head trauma.

"Users should take steps to avoid direct impact to the head and neck. Data do not demonstrate that the device can prevent concussion or serious head injury. The Q-Collar should not be used if an individual has not been medically cleared to play contact sports," the FDA said in its statement.

The device can be worn for up to 4 hours at a time and should be replaced after 2 years of active use or upon the product's expiration date, which is listed on the package, whichever comes first, the FDA advises. The Q-Collar is intended for over-the-counter use and will be distributed directly to consumers. However, patients should consult a medical professional if they are unsure whether the Q-Collar is right for them.