Status:
COMPLETED
Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Conditions:
Brain Injuries, Traumatic
Brain Injury Traumatic Mild
Eligibility:
All Genders
14-49 years
Brief Summary
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 profes...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03318822
Start Date
August 1 2017
End Date
December 31 2020
Last Update
May 6 2021
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229