Innovative Concussion Prevention Device
Completed · Not applicable
Conditions studied: Concussion
In brief
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.
Key facts
- Study ID
- NCT02901028
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 20
- Starts
- 2013-04-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2016-09-15
Who can join
Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Normal healthy volunteer
- Able to provide written consent
- Able to tolerate hypercapnia for 1-2 minutes
- Must be 18 years or older
You may not qualify if…
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or head trauma
- Medical contraindications to limited hypercapnia or 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
- Known open eye injuries
- Neck injuries
- Any known airway obstruction
- Any known seizure disorder
- Any altered level of consciousness
- Have suffered an injury to a lower extremity in the past 6 months
- Have undergone ACL reconstruction less than 2 years ago
- Cardiovascular/Respiratory issues
- Known untreated hypertension
- Known cardiomyopathy
- Known exercise intolerance
- Any indication of cardiovascular risk by the Physical Activity Readiness Questionnaire (PAR-Q)
- Under the age of 18 years
Where it is running
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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