Expired Study
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State College, Pennsylvania 16801


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria - College football players


Study is Available At:


Original ID:

R44HD40743-02


NCT ID:

NCT00060827


Secondary ID:


Study Acronym:


Brief Title:

Measuring Head Impacts in Sports


Official Title:

Head Impact Recording Technology for Field Applications


Overall Status:

Withdrawn


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

24 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rick Greenwald, Ph.D.
Principal Investigator

Study Dates

Verification Date:March 2004
Last Changed Date:October 28, 2014
First Received Date:May 14, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Impact Severity
Time Frame:Immediate
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Head Impact Recording Technology (HIRT)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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