Evaluation of Helmet Technology and Head Impact Exposure



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:13 - 25
Updated:3/23/2019
Start Date:July 1, 2018
End Date:June 30, 2019

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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.

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.

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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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