Brain Dynamics in Response to Jugular Vein Compression

Concussion, Mild Clinical Trial

Official title:

Brain Dynamics in Response to Jugular Vein Compression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236389
• Other study ID #: 2016-6895
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

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