Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060827
Status:
WITHDRAWN
Last Update Posted:
2014-10-30
First Post:
2003-05-14
Brief Title:
Measuring Head Impacts in Sports
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Head Impact Recording Technology for Field Applications
Status:
WITHDRAWN
Status Verified Date:
2004-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Head impacts in sports can lead to brain injury even when the participant is wearing a helmet The forces that contribute to brain injury from sports-related head impacts are not well understood This study will test a new device to measure the speed of head impacts among football players
Detailed Description:
Each year 50 to 70 million people in the United States participate in helmeted and unhelmeted sports with the potential for head impacts Such sports include football soccer hockey basketball and boxing Participating in these sports carries the risk of mild traumatic brain injury MTBI The biomechanics of head impacts that result in concussions or other MTBIs are not well understood however it is thought that such impacts correlate with head accelerations Currently there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play This is a major obstacle in understanding the mechanism of MTBI and its prevention This study will evaluate a newly designed miniature device that uses Head Impact Recording Technology HIRT to quantify head acceleration during impact in actual sports play
One hundred college football players will be enrolled in the study Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season Data collected will be assessed to determine the incidence magnitude and duration of head acceleration during impacts on the sports field
One hundred college football players will be enrolled in the study Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season Data collected will be assessed to determine the incidence magnitude and duration of head acceleration during impacts on the sports field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None