Sex and Age Ultrasound Response to Differential Jugular Vein Pressure

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.

Inclusion Criteria:

- Normal healthy volunteer aged 7-60

- Able to provide written consent

- Able to tolerate hypercapnia for 1-2 minutes

Exclusion Criteria:

- Unable to provide written consent

- History of neurological deficits, previous cerebral infarction, or severe head trauma
as indicated through pre-season screening:

- Medical contraindications to restriction of venous outflow via the internal jugular
veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)

- Glaucoma (Narrow Angle or Normal Tension)

- Hydrocephalus

- Recent penetrating brain trauma (within 6 months)

- Known carotid hypersensitivity

- Known increased intracranial pressure

- Central vein thrombosis

- Any known airway obstruction

- Any known seizure disorder