Status:
COMPLETED
Brain Dynamics in Response to Jugular Vein Compression
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Concussion, Mild
Eligibility:
All Genders
7-40 years
Phase:
NA
Brief Summary
Clinical trials have suggested that this device is effective in mitigating changes in brain structure and function in athlete populations. The purpose of the current study is to better understand the ...
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 aged 7-40
- Able to provide written consent
- Able to tolerate hypercapnia for 1-2 minutes
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 :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03236389
Start Date
September 1 2016
End Date
December 1 2020
Last Update
January 26 2023
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229