The US Food and Drug Administration authorized the Q-Collar “brain protection” device despite internal reviewers warning that its supporting research was flawed and failed to show any reduction in concussion risk, according to an investigative essay published in The BMJ.
Researchers found that the Q-Collar—a $199 “brain protection” device manufactured by Q30 Innovations—was cleared by the Food and Drug Administration (FDA) despite inconclusive data, unverified hypotheses, and multiple research anomalies. The report concluded that the evidence supporting the device’s effectiveness is scientifically unsound and potentially compromised by methodological flaws and data inconsistencies. More than 46,000 units have been sold, and the device has been adopted by professional athletes in the NFL and other contact sports.
"We are now in a situation where a device that restricts blood flow and is worn around the neck, that has not been shown to provide any clinical benefit, is being sold to vulnerable populations—including children as young as 13. It’s time for the FDA to review its decision," noted the lead author James M Smoliga, of the Department of Rehabilitation Sciences, Tufts University School of Medicine, Boston, Massachusetts, and colleagues.
The Q-Collar is a semi-rigid, C-shaped silicone band designed to apply mild external pressure to the jugular veins, purportedly increasing intracranial blood volume to minimize brain movement during impact. The FDA authorized the device in February 2021 as a class II (moderate-risk) medical device after reviewing studies suggesting magnetic resonance imaging-based biomarkers “appeared” to indicate brain protection. The FDA acknowledged in fine print that "data do not demonstrate that the device can prevent concussion or serious head injury. FDA documents obtained through a freedom of information request showed that agency reviewers had flagged these pivotal studies as “flawed,” with altered endpoints and analyses conducted without institutional review board or FDA approval. The FDA's own statistical reviewer had recommended against authorization, finding that key studies "failed to meet the specified endpoints."
The scientific rationale behind the Q-Collar originated from internist David Smith, MD, who claimed that woodpeckers’ resistance to head injury stemmed from jugular vein compression. However, Smith never conducted direct studies on woodpeckers, relying instead on speculative rodent data. Q30 subsequently funded more than $3 million in research between 2015 and 2018 to Greg Myer, PhD, at Cincinnati Children’s Hospital. When early clinical trials failed to show concussion prevention, study endpoints were retroactively modified to focus on magnetic resonance imaging-based surrogate measures.
Further forensic review uncovered duplicated and mathematically inconsistent data across Q30-funded studies, including identical working memory scores reported in separate trials involving soccer players and SWAT team members. The Journal of Neurotrauma has since issued expressions of concern for six publications linked to the Q-Collar’s evidence base. Professional athletes who tested the device reported not noticing protective effects, according to interviews in the essay.
The researchers reported no competing interests.
Source: The BMJ