Evaluation of Helmet Technology and Head Impact Exposure

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.

Study Overview

• Status: Completed
• Conditions: Concussion, Mild; MTBI - Mild Traumatic Brain Injury
• Intervention / Treatment: Other: Helmet Model

Detailed Description

Sports-related traumatic brain injury (sTBI) is common in competitive sports and recreational activities, with 1.6 to 3.8 million reported annually in the U.S. Children, adolescents and young adults are at the highest risk for sustaining mild TBI. There is scarce high-level prospective, objective evidence indicating that any recent helmet design can prevent sTBI. While helmets were developed for, and are effective in, preventing skull fractures and intracranial hematomas, it is unclear if they afford protection against forces inside the cranium.

This study will investigate the relationship between potential changes in brain structure and function pre and post season compared to helmet make and model and head impact exposure in high school and college athletes playing a collision sport such as football. The use of helmets/headgear during such a high-risk sport will allow for collision measurement devices to be affixed to the athlete under the helmet and will not affect play or fit of equipment. By the nature of the sport selected, it is likely this study will primarily include males, however if any female meets inclusion criteria on the team selected, the participant will be included in this investigation. All participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the helmet model will be determined via differences in longitudinal brain imaging and functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The investigators will also enroll a group of athletes involved in a non-contact sport (such as cross country) to act as controls.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Helmet type; football player helmet model	Other: Helmet Model; helmet model worn by football players

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain DTI	change in DTI scan of the brain from pre to post season scans targeting specific regions of interest	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Gregory D Myer, PhD, Cincinnati Childrend Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 2018-2799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No