Innovative Concussion Prevention Device
Condition: Concussion
Study type: Interventional

Summary: 
      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 that applies mild jugular compression according to
      the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood
      physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and
      balance in a population of athletes wearing the Device. Secondly, to determine the tolerance
      and acceptance of the Device while undergoing exertion.
    

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. The January, 2008 New England Journal of
      Medicine reports, "Head and neck injuries, including severe brain trauma, have been reported
      in one quarter of service members who have been evacuated from Iraq and Afghanistan"[1-3].
      The vast majority of these injuries have resulted from exposure to improvised explosive
      device (IED) blast waves. Head injuries, concussions and the resulting trauma have been in
      public discussion recently as the National Football League (NFL) deals with a lawsuit
      regarding head injuries by about one-third of living former NFL players and are also a
      concern for athletes who participate in a wide range of sports, including hockey, rugby and
      soccer.

      According to NASA, "The oscillation of a fluid caused by external force, called sloshing,
      occurs in moving vehicles containing liquid masses, such as trucks, etc." This oscillation
      occurs when a vessel is only partially filled. Similarly, the brain faces slosh peril during
      external force impartation. Slosh permits external energies to be absorbed by the contents of
      a partially filled vessel or container by means of inelastic collisions. Tissues of differing
      densities can decelerate at different rates creating shear and cavitation. If the collisions
      between objects or molecules are elastic, the transfer of energies to those objects
      diminishes, minimizing the energies imparted by slosh.

      Woodpeckers, head ramming sheep and all mammals (including mankind) have small, little known
      and misunderstood muscles in their necks called the omo-hyoid muscles. Highly G-tolerant
      creatures of the forest have utilized these muscles to gently restrict outflow of the
      internal jugular veins thereby "taking up" the excess compliance of the cranial space and
      ultimately protecting themselves from TBI like tiny "airbags" in a motor vehicle.

      This study utilizes a randomized cross over study design. Subjects will visit the Human
      Performance Laboratory on two separate occasions to perform the testing procedures listed in
      the table below. During one testing session, the subject will perform the testing procedures
      while wearing the Device under investigation while the other testing session will be
      completed while the subject is wearing a sham arm device, which will be placed on the upper
      arm and not cause venous engorgement. The order of the testing sessions will be randomized
      prior to the subject's arrival for the first session. The Device is a standard hockey neck
      guard, adapted for the purposes of this study. The Device incorporates two bulges localized
      over the site of the internal jugular veins bilaterally. Experiments performed with jugular
      Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins
      are reduced, while flow within the carotid arteries and all portions of the cerebrum are
      preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will
      not cause any untoward health risks. The pressure exerted by the Device on the region of the
      neck superficial to the internal jugular vein is akin to the pressure felt when a person
      yawns or wears a snugly fitting necktie.
    

Intervention name(s): Laboratory testing; Blood and Urine Draws
Intervention type(s): Other; Other
Intervention description(s): Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.; subjects will have a blood draw and provide a urine sample
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)