Ignite Creation Date:
2024-05-06 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02757053
Status:
TERMINATED
Last Update Posted:
2018-05-14
First Post:
2016-04-27
Brief Title:
Screening Brain MRI in High School Football Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury
Sponsor:
Mosaic Life Care
Organization:
Mosaic Life Care
Study Overview
Official Title:
Screening Brain MRI in High School Football What is the Risk of Traumatic Brain Injury and Does the Guardian Cap Reduce the Incidence of Injury as Determined by Fluid-attenuated Inversion Recovery FLAIR and Susceptibility Weighted Imaging SWI Magnetic Resonance Imaging MRI Sequences
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated June 28 2016 for low enrollment and PI moving away No results were obtained
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Screening Brain magnetic resonance imaging MRI with Fluid-attenuated Inversion Recovery FLAIR and Susceptibility Weighted Imaging SWI sequences will be performed pre and post season on high school football players One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season
Detailed Description:
Screening Brain Magnetic Resonance Imaging MRI with Fluid-attenuated Inversion Recovery FLAIR and Susceptibility Weighted Imaging SWI sequences will be performed pre and post season on high school football players One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only The investigators will compare outcomes of ImPACT concussion scores and MRI findings on FLAIR and SWI sequences between the two groups to see if there is a statistical difference in reduction of MRI findings on FLAIR and SWI sequences or adverse ImPACT concussion score outcomes and to establish what the baseline level of MRI findings on FLAIR and SWI sequences related to injury from high school football is as well as what the baseline level of MRI findings on FLAIR and SWI is prior to the start of the season
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None