Status:
COMPLETED
Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
MTBI - Mild Traumatic Brain Injury
Concussion, Mild
Eligibility:
All Genders
13-19 years
Phase:
NA
Brief Summary
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and comp...
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 13 years or older and a participant on a high school football or soccer team
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
- Prothrombotic or hyperthrombotic condition
- Cerebral cavernous malformation
- Players not medically cleared to play sports
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT04068883
Start Date
July 1 2018
End Date
June 30 2019
Last Update
August 24 2020
Active Locations (2)
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1
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229