The Food and Drug Administration (FDA) has approved the marketing of Q-Collar (Q30 Sports Science), a non-invasive device designed to be worn around the neck of athletes aged 13 and over to help protect athletes Brain from the effects associated with repetitive subconcussive head butts.
Q-collar is a C-shaped collar that applies compressive force to the internal jugular veins of the neck, increasing the volume of blood in the blood vessels of the skull. The increase in blood volume causes the brain to sit closer to the skull, reducing the sloshing motion of the brain around the skull and protecting it from the effects of headbuttons. In addition, the device can reduce the occurrence of specific changes in the brain that are associated with brain injury.
The safety and effectiveness of Q-Collar has been evaluated through several studies, including a prospective longitudinal study of 284 athletes aged 13 and over on a high school soccer team. The athletes were divided into a Q-collar group (n = 139) and a no-collar group (n = 145). Everyone had to wear an accelerometer to measure any head impact during the game. Magnetic resonance imaging (MRI) was required for each participant before and after the season. These scans were used to create diffusion tensor imaging of the brain that researchers could use to compare structural changes in athletes’ brains after a sports season.
Of the 139 athletes who wore the Q-collar, 77% showed no significant changes in the deeper tissues of the brain involved in transmitting electrical nerve signals (white matter regions). In comparison, 73% of the athletes in the no-collar group showed significant changes in these regions. These differences seem to indicate some brain protection associated with the use of the device. No significant adverse events were observed.
The device has not been studied and should be avoided in athletes with: increased pressure in the skull (including uncontrolled ocular glaucoma); increased presence of acid in the body or excessive blood alkalinity; Injury to the open head (including in or around the eye) within the past 6 months; Pseudotumor cerebri; Presence of a brain or spinal shunt; Accumulation of cerebrospinal fluid in the brain; known seizure disorders, tracheal abnormalities, airway obstruction, or carotid hypersensitivity; Blood clots in the brain or an increased chance of blood clotting. In addition, it should not be used on people with enlarged and irregular collections of small blood vessels in the brain, or on people with broken skin, rash, or other abnormalities on or around the neck.
Q-Collar is an over-the-counter product that can be worn for up to 4 hours straight and should be replaced after 2 years of active use or after the device’s expiration date, whichever is earlier. It is not a substitute for and should be worn in addition to other sports-related protective equipment.
The FDA approves the marketing of novel devices to protect athletes’ brains from head butts. [press release]. Silver Spring, MD: US Food and Drug Administration; February 26, 2021.
This article originally appeared on MPR