search
Back to results

Brain Dynamics in Response to Jugular Vein Compression

Primary Purpose

Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Q Collar
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Concussion, Mild

Eligibility Criteria

7 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collar Wearing

Arm Description

subjects will wear collar during MRI testing

Outcomes

Primary Outcome Measures

Changes in brain structure while wearing Q collar seen via MRI
measure changes in brain structure on MRI

Secondary Outcome Measures

Full Information

First Posted
January 10, 2017
Last Updated
January 24, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT03236389
Brief Title
Brain Dynamics in Response to Jugular Vein Compression
Official Title
Brain Dynamics in Response to Jugular Vein Compression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collar Wearing
Arm Type
Experimental
Arm Description
subjects will wear collar during MRI testing
Intervention Type
Device
Intervention Name(s)
Q Collar
Intervention Description
measuring changes in brain during MRI while wearing the Q collar
Primary Outcome Measure Information:
Title
Changes in brain structure while wearing Q collar seen via MRI
Description
measure changes in brain structure on MRI
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinnati Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Brain Dynamics in Response to Jugular Vein Compression

We'll reach out to this number within 24 hrs