FDA authorizes marketing device to help protect athletes’ brains during head impacts
The U.S. Food and Drug Administration (FDA) authorized a new device intended to be worn around the neck of athletes 13 years old and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts, according to a news release from the agency.
The non-invasive device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts. The device may reduce the occurrence of specific changes in the brain that are associated with brain injury, the FDA said.
Traumatic brain injury (TBI) can be caused by a forceful bump, blow, or jolt to the head or body, or from an object that pierces the skull and enters the brain. Not all blows or jolts to the head result in a TBI. According to the Centers for Disease Control and Prevention, from 2006 to 2014, the number of TBI-related emergency department visits, hospitalizations, and deaths increased by 53 percent. Blunt trauma accidents, or accidents that involve being struck by or against an object, particularly sports-related injuries, are a major cause of TBI. The National Institute of Neurological Disorders and Stroke notes that anywhere from 1.6 million to 3.8 million sports- and recreation-related TBIs are estimated to occur in the United States annually.
When worn around the neck during sports activities, the Q-Collar provides compressive force to the internal jugular veins, which in turn increases the blood volume in the skull’s blood vessels. Typically, when people experience blunt trauma accidents, the brain moves unrestrained in the skull, which is known as a “slosh.” The Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces the “slosh” movement. By reducing the movement of the brain within the cranial space, the Q-Collar may aid in the protection of the brain from the effects of head impacts.
The FDA assessed the safety and effectiveness of the Q-Collar through several studies, including a prospective, longitudinal study in the United States with 284 subjects 13 years old or older who were participants on a high school football team. During the sports season, 139 athletes wore the Q-Collar and 145 athletes did not.
All participants also wore an accelerometer device that measured every impact to the head sustained during play. Each athlete underwent a magnetic resonance imaging (MRI) scan pre-season and post-season. These MRI scans were used to generate Diffusion Tensor Imaging (a specialized MRI 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 the transmission of electrical nerve signals (white matter regions) in 106 of the 145 (73 percent) participants in the no-Collar group, while no significant changes in these regions were found in 107 of the 139 (77 percent) of the group who wore the Q Collar. These differences appear to indicate protection of the brain associated with device use. No significant adverse events were associated with device use.
