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After the Food and Drug Administration (FDA) recently approved a new device that could help reduce the risk of traumatic brain injury (TBI) during head impacts, experts are reportedly now coming with skepticism.
According to the Centers for Disease Control and Prevention (CDC), each year an estimated 1.5 million people in the U.S. sustain a TBI. Moreover, it is a leading cause of death and disability among children and young adults in the country. Of those hospitalized for this type of injury, 230,000 survive, 50,000 die, and 80,000 to 90,000 people experience the onset of long-term disability. Sports and recreational activities alone contribute to an estimated 1.6 to 3.8 million traumatic brain injuries annually in the U.S.
In a few interviews with ABC News, some experts cited what they said is a lack of evidence that the device, called a Q-Collar, can prevent traumatic brain injuries and that it may give wearers a false sense of security.
The Q-Collar fits around the back and side of the neck and is shaped like a C. It works by clamping down on blood vessels in the neck, which increases blood volume in the skull. This limits the movement of the brain inside the skull, which researchers believe generally causes traumatic brain injury. It can be purchased without a prescription, but not all experts are sold on it.
Adil Hussain, D.O., a physical medicine and rehabilitation doctor who specializes in brain injury medicine at Rancho Los Amigos National Rehabilitation Center in California said that in theory, the Q-collar makes sense. He explained how in theory, the Q-Collar is serving as a quasi-seat belt. “Think of it like a car accident: If your brain is a crash dummy, without a seat belt, it will fly around in the car,” he said. “The purpose of the seat belt is to tie down the dummy to prevent it from moving within the car.”
However, Hussain and other experts warned that consumers should be aware of the device’s limitations. They said that though studies show it might help prevent micro-injuries in the brain, the data stop short of showing the device can prevent serious brain injuries or concussions, a milder form of brain injury.
Moreover, experts also said increasing blood supply to the brain, which the Q-Collar does applying pressure to the neck, may not be safe for everyone. Hussain further explained: “We must also consider what else could happen to the brain when the jugular veins are compressed. The brain sits in an enclosed space within a hard skull, and thus has very little room to expand if put under additional pressure.”
According to the FDA, the device was primarily tested in teen and young adult athletes and shouldn’t be used by people with a wide range of medical conditions. Similarly, the FDA’s authorization notice also makes it clear that the Q-Collar hasn’t been proven to “prevent concussions or serious head injury.”
“It’s a troublesome FDA statement because it’s hard to know exactly what [the devices] do for the consumer,” David Putrino, P.T., Ph.D., director of rehabilitation innovation and assistant professor of rehabilitation and human performance in the Mount Sinai Health System said. According to him, the device’s central claim, which is based on specialized brain-imaging findings, is that it might prevent brain damage in the long run by reducing micro-injuries. He would like to see additional long-term studies to prove that.
Putrino added that it would be better to design studies that show the device is capable of reducing the symptoms of TBI, or long-term effects of repetitive head trauma, such as chronic traumatic encephalopathy, commonly called CTE. “The bottom line is that we currently do not have a solid link between the imaging findings that the company is reporting and a propensity to go on and develop CTE or TBI,” he said.
In statement to ABC News, an FDA spokesperson said that “clinical study data supported its safety and effectiveness” to protect the brain from “repetitive sub-concussive head impacts.”
Moreover, according to Thomas Talavage, Ph.D., a brain-imaging expert who worked on the Q-Collar FDA submission, the proposed long-term benefit of the Q-Collar for youth athletes is valuable even if not yet more robustly documented. “I think it’s silly to not utilize it, because if it turns out that there is clinical utility, which I believe it does have, if it turns out at the end of 20 years, yes, this really matters — we’ve got 20 years with athletes who have accumulated injuries that may be debilitating,” Talavage said. “And we could have done something about that.”