Sex and Age Ultrasound Response to Differential Jugular Vein Pressure
Condition: Concussion, Mild
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Clinical trials have suggested that this device is effective in mitigating changes in brain
      structure and function in athlete populations. The purpose of the current study is to measure
      the response of the jugular vein to various pressures applied by a generic compression device
      across various ages and gender. The relative jugular vein response will be measured using
      ultrasound.
    

Detailed description: 
      The Device has the promise of providing a novel mechanism for reducing or preventing the
      likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the
      leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated
      at anywhere from $50 to $150 billion, annually. Concussion in female high school soccer
      players have been noted to occur at a rate of 4.5 concussions per 10,000 athletic exposures
      (Comstock, Currie et al. 2015). The investigators propose that Slosh Theory can explain these
      differences offering a mechanistic approach that could help shed light on further ways to
      alleviate the TBI burden on society. Note that Slosh Theory teaches that hydrodynamics
      (fluids moving within moving containers) contribute to, or are even the main etiology for,
      energy absorption of the cranial contents and that mitigation of SLOSH (increased
      compensatory reserve volume) may mitigate TBI. Significant morbidity, mortality, and related
      costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device
      worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast
      trauma or concussive events, would save lives, and the huge costs currently being experienced
      for life-treatment of surviving victims. An externally-worn medical device (the Device) that
      applies mild jugular vein compression according to the principle of the Queckenstedt
      Maneuver, is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests
      that the Device has the potential to reduce the likelihood of TBI. The currently developed
      collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been
      approved for studies in humans (IRB 2013-2240) and the results indicate safety for use during
      high demand and maximal exertion activities. Regarding safety, the externally worn collar is
      meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins
      that will provide similar pressure and volume increases not to surpass that of a yawn or the
      mere act of just lying down. Initial safety testing and early clinical trials indicate that
      the collar application is both safe and efficacious to prevent brain microstructure and
      neurophysiological changes in response to head impacts.
    

Intervention name(s): Q-collar
Intervention type(s): Device
Intervention description(s): capture ultrasound images at each pressure point
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other