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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03236389
Other study ID # 2016-6895
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date December 2020

Study information

Verified date January 2023
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 underlying mechanistic response of the brain hemodynamics to mild jugular vein compression


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 mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device (the Device) that applies mild jugular vein compression according to the principle of the Queckenstedt Maneuver, is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been approved for studies in humans (IRB 2013-2240) and the results indicate safety for use during high demand and maximal exertion activities. Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. Initial safety testing and early clinical trials indicate that the collar application is both safe and efficacious to prevent brain microstructure and neurophysiological changes in response to head impacts.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 40 Years
Eligibility Inclusion Criteria: - Normal healthy volunteer aged 7-40 - Able to provide written consent - Able to tolerate hypercapnia for 1-2 minutes 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Q Collar
measuring changes in brain during MRI while wearing the Q collar

Locations

Country Name City State
United States Cincinnati Childrens Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in brain structure while wearing Q collar seen via MRI measure changes in brain structure on MRI immediate
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