Brain InjuriesNCT00060827
Measuring Head Impacts in Sports
An observational study of Brain Injuries and Brain Concussion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Brain Concussion
- What is being tested?
- Head Impact Recording Technology (HIRT)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- College football players
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
State College, Pennsylvania, 16801
About this study
Official title: Head Impact Recording Technology for Field Applications
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.
Read the 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.
- Conditions
- Brain Injuries, Brain Concussion
- Being tested
- Head Impact Recording Technology (HIRT)
- Keywords
- Mild traumatic brain injury
- Medical subject headings
- Brain Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head Impact Recording Technology (HIRT)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact Severity
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Rick Greenwald, Ph.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060827
- Sponsor's protocol ID
- R44HD040743-02
- Status last verified
- Mar 2004
- First submitted
- 14 May 2003
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Impact Recording Technology for Field Applications
- ClinicalTrials.gov ID
- NCT00060827
- Acronym / sponsor ID
- R44HD040743-02
- Conditions
- Brain Injuries, Brain Concussion
- Keywords
- Mild traumatic brain injury
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- First posted
- 15 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College football players
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head Impact Recording Technology (HIRT) | Device | – |
Primary outcome
Impact Severity
Time frame: Immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Greenwald, Ph.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Brain Concussion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact Severity (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.