NCT03236389

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

4.3 years

First QC Date

January 10, 2017

Last Update Submit

January 24, 2023

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

  • Changes in brain structure while wearing Q collar seen via MRI

    measure changes in brain structure on MRI

    immediate

Study Arms (1)

Collar Wearing

EXPERIMENTAL

subjects will wear collar during MRI testing

Device: Q Collar

Interventions

Q CollarDEVICE

measuring changes in brain during MRI while wearing the Q collar

Collar Wearing

Eligibility Criteria

Age7 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Normal healthy volunteer aged 7-40
  • Able to provide written consent
  • Able to tolerate hypercapnia for 1-2 minutes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Gregory D Myer, PhD

    Cincinnati Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

August 1, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)