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NCT04068883 · ClinicalTrials.gov registry record · NA
Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 488
- Enrollment target
NCT04068883: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04068883 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 488 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04068883, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 488 participants
- Enrollment target
Study Summary
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: * Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. * Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.
Primary Outcome
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
Interventions
- OTHER Q collar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT04068883 record still lists
NCT04068883 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Q collar is the first listed.
NCT04068883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04068883 about?
NCT04068883 is a clinical study titled "Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar". The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the effic...
What is the current status of trial NCT04068883?
This trial is currently completed. It is a NA study. The enrollment target is 488 participants. The study started on 2018-07-01. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT04068883?
The interventions under investigation include: Q collar (OTHER).
Who is sponsoring clinical trial NCT04068883?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04068883's enrollment target sits among peer trials
488 215th of 2000 higher than 1,785 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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