Brain Dynamics in Response to Jugular Vein Compression

Status Completed

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03236389
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Completed
Phase	N/A
Start date	September 2016
Completion date	December 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05849064` - Concussion Treatment in Older Adults	N/A
Terminated	`NCT04586179` - A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion	N/A
Not yet recruiting	`NCT05943561` - Biomarkers in Concussion
Completed	`NCT02721537` - Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes	N/A
Completed	`NCT01832714` - Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Completed	`NCT04560400` - Reverse King-Devick Test and History of Multiple Concussions	N/A
Completed	`NCT03678077` - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Recruiting	`NCT05262361` - Persistent Post-Concussion Symptoms With Convergence Insufficiency	N/A
Recruiting	`NCT05105802` - Mindfulness-Based Intervention for Mild Traumatic Brain Injury	N/A
Terminated	`NCT03123822` - Spectacles Lens in Concussed Kids	N/A
Completed	`NCT04641832` - The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health	N/A
Completed	`NCT04074486` - Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Withdrawn	`NCT04578743` - Exercise as Concussion Therapy Trial- 2	Phase 2
Completed	`NCT03671083` - Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Completed	`NCT03170856` - The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion	N/A
Completed	`NCT05069948` - Delivery of Digital Cognitive Behavioural Therapy Following Concussion	N/A
Recruiting	`NCT03889483` - Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion	N/A
Withdrawn	`NCT02959294` - Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries	Early Phase 1
Recruiting	`NCT06093295` - Non-invasive Brain Stimulation and Injury Risk Biomechanics	N/A
Completed	`NCT02280304` - Meditation in Veterans With PTSD and Mild TBI	N/A