NCT03017924

Brief Summary

The purpose of the study is to monitor changes in brain structure and function between the pre-training and post-training, in a population of tactical team members wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 10, 2017

Results QC Date

July 28, 2020

Last Update Submit

January 28, 2021

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (2)

  • Blast Explosive Waves Experienced During the Training

    The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing

    single breacher training day

  • Average Peak Pressure Differences Between Groups

    between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI

    Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.

Secondary Outcomes (2)

  • Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar

    Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.

  • Change in DP-NF Value (Reported in Hz)

    Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.

Study Arms (2)

Q collar

EXPERIMENTAL

Subjects that will wear the Q collar during the breacher training

Device: Q collar

No collar

NO INTERVENTION

Subjects that will not wear the Q collar during the breacher training

Interventions

Q collarDEVICE

q-collar concussion prevention device

Q collar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal healthy volunteer
  • Able to provide written consent

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-tactical training 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

Results Point of Contact

Title
Kim Foss
Organization
Cincinnati Childrens Hospital
kim.foss@cchmc.org
5136365971

Study Officials

  • Gregory D Myer, PhD

    Cincinanti Childrens Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

February 16, 2021

Results First Posted

February 16, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)