Brain Injuries, Traumatic Clinical Trial
Official title:
Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
Verified date | May 2021 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2020 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Emory University | Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerability of collar usage | measure subject tolerability to wearing the device via weekly survey | 1 year | |
Secondary | Compliance of collar usage | measure subject compliance to wearing the device via weekly survey completion | 1 year |
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