NCT03318822

Completed

Usability and Tolerability of Novel Protection Device Agains...

Emory University Source

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Other study identifiers

Sponsor study identifier

STUDY00001960

Secondary identifiers

2016-9625

OTHER · CCHMC

Study Type

observational

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

August 1, 2017

Actual (reported)

Primary Completion

July 30, 2020

Actual (reported)

Study Completion

December 31, 2020

Actual (reported)

Brief Summary

The purpose of the study is to assess the usability and tolerability of this jugular vein compression device in a population of helmeted and non-helmeted competitive high school, collegiate and professional athletes in the sports of football and rugby. This study differs from previous work in that it is designed to capture additional data related to the athlete experience wearing the jugular vein compression device in older and more elite playing levels.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: December 31, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 1, 2017
Actual (reported)
First Submitted
August 21, 2017
Actual (reported)
First Posted
October 24, 2017
Actual (reported)
Primary Completion
July 30, 2020
Actual (reported)
Study Completion
December 31, 2020
Actual (reported)

Last Updated: May 6, 2021
Status Verified: May 2021
Last Update Submitted: May 3, 2021

Conditions

Brain Injuries, Traumatic Brain Injury Traumatic Mild

Keywords

brain injury

Outcome Measures

Primary Outcomes (1)

Tolerability of collar usage
measure subject tolerability to wearing the device via weekly survey
1 year

Secondary Outcomes (1)

Compliance of collar usage
1 year

Study Arms (1)

Q-Collar

Subjects wearing the Q-Collar

Device: Q-Collar

Interventions

Q-CollarDevice

An externally-worn medical device that applies mild jugular compression

Q-Collar

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age14 Years - 49 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Normal healthy volunteers aged 14-49

You may qualify if:

Normal healthy volunteer

Sponsors & Collaborators

Emory University
Otherlead
Children's Hospital Medical Center, Cincinnati
Othercollaborator

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain ConcussionBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

Gregory D Myer, PhD
Cincinnati Childrens Hospital
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

August 21, 2017

First Posted

October 24, 2017

Study Start

August 1, 2017

Actual (reported)

NCT06129565

The Use of Q-Collar to Increase CSF Drainage in Low-pressure Hydrocephalus Patients

Not ApplicableWithdrawn

NCT02496975

Traumatic Brain Injury and Effects of Acute Cyclosporine A

Phase 1/2Withdrawn

NCT03401645

Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury

Not ApplicableCompleted

NCT03698747

Myelin Imaging in Concussed High School Football Players

Terminated

NCT03438409

Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

Not ApplicableTerminated

NCT03169647

Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury

Not ApplicableCompleted

Able to provide written consent

Must be 14 years or older and a participant in collegiate/professional sports of football or rugby

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.

Primary Completion

July 30, 2020

Actual (reported)

Study Completion

December 31, 2020

Actual (reported)

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03318822
Data provider: ClinicalTrials.gov
Source updated: 2021-05-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:34 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Q-Collar

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations