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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00060827
Other study ID # R44HD040743-02
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 14, 2003
Last updated October 28, 2014

Study information

Verified date March 2004
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria

- College football players

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
Head Impact Recording Technology (HIRT)


Locations

Country Name City State
United States Penn State University State College Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact Severity Immediate
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