Brain Dynamics in Response to Jugular Vein Compression

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 7-40

- 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