Status:
COMPLETED
Q-collar and Brain Injury Biomarkers
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Concussion
Eligibility:
All Genders
14-19 years
Phase:
NA
Brief Summary
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...
Detailed Description
The Device has the promise of providing a novel mechanism for reducing or preventing the likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the leading cause of ...
Eligibility Criteria
Inclusion
- • Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on a competitive and organized sports program
- Neck circumference of 15 ½ - 16 ½ inches
Exclusion
- • Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma
- 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 :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02271451
Start Date
October 1 2014
End Date
October 1 2015
Last Update
September 4 2020
Active Locations (1)
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1
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45209