Evaluation of Helmet Technology and Head Impact Exposure

Concussion, Mild Clinical Trial

Official title:

Evaluation of Helmet Technology and Head Impact Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883451
• Other study ID #: 2018-2799
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 15, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Mild
• MTBI - Mild Traumatic Brain Injury

Intervention

Other:
• Helmet Model
helmet model worn by football players

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain DTI	change in DTI scan of the brain from pre to post season scans targeting specific regions of interest	6 months