Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
Completed
Conditions studied: Brain Injuries, Traumatic, Brain Injury Traumatic Mild
In brief
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.
Key facts
- Study ID
- NCT03318822
- Run by
- Emory University
- People needed
- 200
- Starts
- 2017-08-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-05-06
Who can join
Age: 14 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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