The Food and Drug Administration (FDA) has authorized the marketing of Q-Collar (Q30 Sports Science), a noninvasive device intended to be worn around the neck of athletes 13 years of age and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts.
Q-Collar is a C-shaped collar that applies compressive force to the internal jugular veins of the neck, which increases blood volume in the skull’s blood vessels. The increase in blood volume creates a tighter fit of the brain in the skull, thereby reducing the “slosh” movement of the brain within the cranial space, and protecting it from the effects of head impacts. Additionally, the device may reduce the occurrence of specific changes in the brain that are associated with brain injury.
The safety and efficacy of Q-Collar were assessed through several studies including a prospective, longitudinal study in 284 athletes aged 13 years and older in a high school football team. Athletes were divided into a Q-Collar group (n=139) and a no-collar group (n=145), and all were required to wear an accelerometer device to measure every impact to the head sustained during play. A magnetic resonance imaging (MRI) scan pre- and post-season was required for each participant. These scans were used to generate Diffusion Tensor Imaging of the brain that allowed researchers to compare structural changes in the athletes’ brain 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 the transmission of electrical nerve signals (white matter regions). In comparison, 73% of athletes in the no-collar group demonstrated significant changes in these regions. These differences appear to indicate protection of the brain associated with device use. 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; open head injury (including in or around the eye) within the past 6 months; pseudotumor cerebri; presence of brain or spinal shunt; accumulation of cerebrospinal fluid within the brain; known seizure disorder, trachea abnormality, airway obstruction, or carotid hypersensitivity; blood clot in the brain or increased likelihood of blood clotting. Additionally, it should not be used in individuals with collections of small blood vessels in the brain that are enlarged and irregular in structure, or in those with skin injury, rash, or other abnormality on or around the neck.
Q-Collar is an over-the-counter product intended to be worn for up to 4 hours at a time and should be replaced after 2 years of active use or upon the device’s expiration date, whichever is earlier. It does not replace, and should be worn in addition to other protective sports equipment associated with the sport.
FDA authorizes marketing of novel device to help protect athletes’ brains during head impacts. [press release]. Silver Spring, MD: US Food and Drug Administration; February 26, 2021.