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NCT03883451 · ClinicalTrials.gov registry record · NA
Evaluation of Helmet Technology and Head Impact Exposure
A NA study of Concussion, Mild and mTBI - Mild Traumatic Brain Injury, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT03883451: Completed NA study of Concussion, Mild and mTBI - Mild Traumatic Brain Injury, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03883451 is a NA study of Concussion, Mild and mTBI - Mild Traumatic Brain Injury that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 250 participants, above the 190-participant average among 18 other Concussion, Mild trials with a reported enrollment target (32% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883451, a NA study of Concussion, Mild and mTBI - Mild Traumatic Brain Injury, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
change in DTI scan of the brain from pre to post season scans targeting specific regions of interest
Conditions Studied
Interventions
- OTHER Helmet Model
Study Locations (1)
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2021-01-15 |
| Phase | NA |
What the finished NCT03883451 record still lists
NCT03883451 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 190-participant average among 18 other Concussion, Mild trials with a reported enrollment target (32% higher).
The record links to 2 conditions, with Concussion, Mild appearing as the primary indexed condition, and to 1 intervention - of which Helmet Model is the first listed.
NCT03883451 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03883451 about?
NCT03883451 is a clinical study titled "Evaluation of Helmet Technology and Head Impact Exposure". 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 ...
What is the current status of trial NCT03883451?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2018-07-01. Estimated completion is 2021-01-15.
What conditions does trial NCT03883451 study?
This clinical trial studies the following conditions: Concussion, Mild, mTBI - Mild Traumatic Brain Injury.
What interventions are being tested in trial NCT03883451?
The interventions under investigation include: Helmet Model (OTHER).
Who is sponsoring clinical trial NCT03883451?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03883451 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03883451's enrollment target sits among peer trials
250 5th of 18 higher than 13 of 18 other Concussion, Mild trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion, Mild trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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