Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 14 - 49 |
| Updated: | 10/26/2017 |
| Start Date: | August 1, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Kim D Barber Foss, MS |
| Email: | kim.foss@cchmc.org |
| Phone: | 513-636-5971 |
The purpose of the study is to assess the usability and tolerability of this jugular vein
compression device in a population of helmeted and non-helmeted competitive high school,
collegiate and professional athletes in the sports of football and rugby. This study differs
from previous work in that it is designed to capture additional data related to the athlete
experience wearing the jugular vein compression device in older and more elite playing
levels.
compression device in a population of helmeted and non-helmeted competitive high school,
collegiate and professional athletes in the sports of football and rugby. This study differs
from previous work in that it is designed to capture additional data related to the athlete
experience wearing the jugular vein compression device in older and more elite playing
levels.
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 incurred 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 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 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 tolerability of this device in
athletes participating in the competitive sports of football and rugby at the high school,
collegiate or professional levels.
(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 incurred 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 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 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 tolerability of this device in
athletes participating in the competitive sports of football and rugby at the high school,
collegiate or professional levels.
Inclusion Criteria:
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant in collegiate/professional sports of
football or rugby
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
We found this trial at
1
site
Cincinnati, Ohio 45229
Principal Investigator: Gregory D Myer, PhD
Phone: 513-636-5971
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