Evaluation of Helmet Technology and Head Impact Exposure
Primary Purpose
MTBI - Mild Traumatic Brain Injury, Concussion, Mild
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet Model
Sponsored by
About this trial
This is an interventional prevention trial for MTBI - Mild Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- Cincinnati Childrens Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Helmet type
Arm Description
football player helmet model
Outcomes
Primary Outcome Measures
Change in brain DTI
change in DTI scan of the brain from pre to post season scans targeting specific regions of interest
Secondary Outcome Measures
Full Information
NCT ID
NCT03883451
First Posted
December 27, 2018
Last Updated
January 26, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03883451
Brief Title
Evaluation of Helmet Technology and Head Impact Exposure
Official Title
Evaluation of Helmet Technology and Head Impact Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MTBI - Mild Traumatic Brain Injury, Concussion, Mild
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group of football athletes
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helmet type
Arm Type
Experimental
Arm Description
football player helmet model
Intervention Type
Other
Intervention Name(s)
Helmet Model
Intervention Description
helmet model worn by football players
Primary Outcome Measure Information:
Title
Change in brain DTI
Description
change in DTI scan of the brain from pre to post season scans targeting specific regions of interest
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinnati Childrend Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Helmet Technology and Head Impact Exposure
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