FDA Clears Marketing of Q-collar

Introduction

On February 26, 2021, Food and Drug Administration (FDA) authorized marketing of Q-Collar intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from impacts. It is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts.

 

What does it do?

When worn around the neck during sports activities, the Q-Collar provides compressive force to the internal jugular veins, which in turn increases the blood volume in the skull’s blood vessels. Typically, when the brain experiences an impact, it moves back and forth in the skull. The Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces its movement and thus may aid in the protection of the brain from the effects of head impacts.

 

Assessment by FDA

The FDA assessed the Q-Collar through several studies, including a prospective, longitudinal study in the United States with 284 subjects 13 years or older who were participants on a high school football team. During the sports season, the participants are divided into a Q-collar group and a non-Q-collar group. All participants wore an accelerometer device that measured every impact to the head sustained during play and underwent a magnetic resonance imaging (MRI) scan pre-season and post-season to compare structural changes in the participants’ brain after a season of play.

 

In 73% participants in the no-Collar group, significant changes were found in the white matter regions of the brain which are involved in the transmission of electrical nerve signals. However, no significant changes in these regions were found in 77% of the group who wore the Q-Collar. These differences appear to indicate protection of the brain associated with device use. No significant adverse events were associated with device use.

 

A Note

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 six months

  • Pseudotumor cerebri (false brain tumor)

  • Presence of brain or spinal shunt

  • Accumulation of cerebrospinal fluid within the brain

  • Known seizure disorder

  • Known trachea abnormality

  • Known airway obstruction

  • Known carotid hypersensitivity

  • Blood clot in the brain

  • Increased likelihood of blood clotting (coagulation)

  • Collections of small blood vessels in the brain that are enlarged and irregular in structure

  • Skin injury, rash, or other abnormality on or around the neck

 

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 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.

References

Office of the Commissioner. “FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts.” U.S. Food and Drug Administration, 26 Feb. 2021, www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-novel-device-help-protect-athletes-brains-during-head-impacts.

“Captcha Challenge….” Quizlet, quizlet.com/98939195/jugular-venous-pressure-and-pulsations-flash-cards. Accessed 24 Mar. 2021.

Eslava-Kim, Lea PharmD. “FDA Clears Q-Collar Device for Athletes.” Neurology Advisor, 3 Mar. 2021, www.neurologyadvisor.com/topics/traumatic-brain-injury/fda-clears-q-collar-device-for-athletes-protection-of-brain.

Resources by Judy Zhu