FDA: Novel device protects athletes from traumatic brain injury, MR imaging shows
The U.S. Food and Drug Administration on Friday authorized a novel product it says may protect athletes from traumatic brain injury based on recent MR imaging findings.
Q-Collar is a C-shaped, noninvasive device that goes around the neck, applying compressive force to increase blood volume and reduce brain movement.
FDA scientists assessed the safety and effectiveness of the device through several studies, including a prospective, long-term analysis of 284 subjects age 13 and older. A group of 139 athletes wore the collars and underwent head MRI before and after the season, while 145 without such protection did the same.
Researchers also generated diffusion tensor imaging of the brain to compare structural changes after a season of play, the FDA explained. They noted significant changes in the deeper tissues involved in the transmission of electrical nerve signals in 73% of the collarless group. Meanwhile, scientists found no such white matter changes in 77% of the group who used Q-Collars.
“These differences appear to indicate protection of the brain associated with the device use,” the FDA’s Center for Devices and Radiological Health reported Feb. 26. “No significant adverse events were associated with device use,” the administration added.
The National Institute of Neurological Disorders and Stroke estimates that upward of 3.8 million sports-related traumatic brain injuries occur in the U.S. each year. FDA officials and manufacturer Q30 Sports Science hope the device will help curb this number, reducing “slosh” by creating a tighter fit of the brain in the skull via an increased blood volume.
Experts noted that the Q-Collar does not replace helmets or other protective devices. And it should not be used by athletes with conditions such as blood clots in the brain, known seizure disorders, or problems with blood clotting.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.