Q-collar and Brain Injury Biomarkers
Condition: Concussion
MeSH terms: Brain Injuries
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 (the Device) is being developed by Q30 Labs, LLC
      (Q30). Initial research suggests that the Device has the potential to reduce the likelihood
      of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith 2012) has
      been approved for studies in humans and the results indicate safety for use during high
      demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board -
      Federalwide Assurance #00002988). 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.

      This study will investigate the effectiveness of this device in high school athletes playing
      a collision or contact sport such as football, hockey, or lacrosse. The high risk sports
      which utilize helmets during competition will allow for measurements systems to be embedded
      in the headgear and will not affect play or fit of equipment. Athletes participating in this
      study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By
      the nature of the sports selected, it is likely this pilot study will primarily include
      males, however if any female meets inclusion criteria on the team selected they will be
      included in this pilot investigation. The helmets of all participants will be outfitted with
      an accelerometer which will measure the magnitude of every impact to the head sustained by
      the athlete. Effectiveness of the device will be determined by brain imaging during the
      pre-season, midseason, and end of season time points. A subset of athletes who report a
      diagnosed concussion will also receive additional brain imaging within the week following the
      diagnosed concussive event.
    

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"(Okie
      2005; Xydakis 2005; Hoge 2008). 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 an 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 omohyoid 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. Rat studies
      by Smith et al. have demonstrated that the investigators can easily and safely facilitate
      this muscle's actions by a well-engineered gentle compression over those muscles.

      The medical Queckenstedt Maneuver devised to detect spinal cord compression, gently places
      pressure over the external jugular veins to increase cerebral spinal volume and pressure. In
      this maneuver, the veins are compressed while a lumber puncture monitors the intracranial
      pressure. "Normally, the pressure rise to the higher 'plateau' level occurs instantly upon
      jugular compression to fall again equally fast upon release of the compression"(Gilland
      1969). This incredibly simple principle can be employed to protect soldiers and athletes from
      TBI by safely, and reversibly, increasing intracranial volume and pressure. The neck collar
      device is made of hytrel (plastic), silicone, metal and fabric that is fitted to the neck
      providing comfortable and precise jugular compression that potentially mitigates cerebral
      slosh (Figure 1).

      Although the skull, blood, and brain are "almost incompressible," the vasculature tree of the
      cerebrum is quite reactive and compressible. As volume is added to the cranium, eventually
      the compensatory reserve volume is surpassed and the intracranial pressure increases
      slightly. Increasing cerebral blood volume by just 1-3% safely and reversibly reduces
      compliance of the cerebral vascular tree and diminishes absorption of slosh energies. Jugular
      compression increases cerebral blood volume almost instantaneously. As mentioned, this degree
      of increase has significantly mitigated slosh and TBI in laboratory animals and mimics the
      highly concussion resistant wild animals that are able to reflexively increase cerebral blood
      volume through jugular compression.

      A landmark article, published in the Journal of Neurosurgery, used a standard
      acceleration-deceleration impact laboratory model of mild TBI. The study showed a successful
      and marked reduction of axonal injury following Internal Jugular Vein (IJV) compression as
      indicated by immunohistochemical staining of Amyloid Precursor Proteins (APP) (Smith 2012;
      Turner 2012). It is argued that IJV compression reduces slosh-mediated brain injury by
      increasing intracranial blood volume and reducing the compliance and potential for brain
      movement within the confines of the skull. The potential for such technique to mitigate both
      linear and rotational brain injury in humans by "internal protection" represents the most
      novel approach to mitigating TBI.

      Summary of Prior Work A. Safety testing in athletes has been approved by the local IRB and
      was completed in the Cincinnati Children's Hospital Human Performance Laboratory (Study ID:
      2013-2240; PI: Gregory Myer). Evaluation of monitored vital signs, biomechanics,
      cardiorespiratory capacity, postural control, dynamic stabilization, reactive index,
      concentration and cognition, memory, strength and power in a population of athletes showed no
      statistically significant adverse effect of wearing a mild jugular vein compressive neck
      collar compared to a sham arm band.(Myer 2013) Cumulatively, the pre and post safety measures
      indicate that neurologic parameters of executive function, eye hand coordination, balance,
      memory and reaction times were unchanged following two hours of physical testing wearing the
      collar prototype. Acceptance of the compression collar was not different in physiological
      biomarker response to non-collared condition during maximal oxygen uptake and maximum effort
      power testing.(Myer 2013) B. Magnetic Resonance Elastography was established at CCHMC in
      collaboration with The Mayo Clinic to support studies. Under jugular vein compression with
      the collar, all subjects tolerated the procedure without any untoward effects. The
      preliminary studies of dynamic shear strain showed no consistent pattern of wave propagation
      and elasticity, placed upon the vascular and cranial tissues. Analysis of these data
      continues.

      C. Four hundred and ten (410) subjects (ages 12 to 68 years of age) were studied with MEPA
      (middle ear power analysis) with and without the compression collar and no complaints or
      untoward effects were noted and no decline in the auditory perception was recorded. The
      expected changes of reduced Acoustic Reflectance of the inner ear and middle ear (indicative
      of reduced compliance) were noted only in subgroup analysis of those with jugular vein
      compression. The results of this study indicate that the neck compression collar prototype
      may have the potential to safely reduce energy impartation into cranial structures (i.e. the
      inner ear), however further work is needed with advanced collar designs to establish this
      effect.

      D. fMRI and CO2 reactivity was performed on twelve adults before and after application of
      jugular vein compression. Results comparing before and after jugular vein compressions (with
      the collar) yielded no alterations in O2 uptake or glucose metabolism to any portion of the
      brain.(Fisher 2013)
    

Intervention name(s): Q collar
Intervention type(s): Device
Intervention description(s): collar worn around neck
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: concussion