NCT03883451

Brief Summary

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model. Secondly, the purpose is to determine the protection of the helmet make and model 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
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

December 27, 2018

Last Update Submit

January 26, 2021

Conditions

MTBI - Mild Traumatic Brain InjuryConcussion, Mild

Outcome Measures

Primary Outcomes (1)

  • Change in brain DTI

    change in DTI scan of the brain from pre to post season scans targeting specific regions of interest

    6 months

Study Arms (1)

Helmet type

EXPERIMENTAL

football player helmet model

Other: Helmet Model

Interventions

Helmet ModelOTHER

helmet model worn by football players

Helmet type

Eligibility Criteria

Age13 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Normal healthy volunteer
  • Able to provide written consent
  • Must be 13 years or older and a participant on a high school or collegiate team

You may not qualify if:

  • Unable to provide written consent
  • Not medically cleared to participate on a high school or collegiate team

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 Childrend Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single group of football athletes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

March 21, 2019

Study Start

July 1, 2018

Primary Completion

December 10, 2020

Study Completion

January 15, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)