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The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
This study will investigate the effectiveness of this device in high school athletes playing a non-helmeted sport such as soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. This study will focus on the use and effectiveness of the device solely in females, as male football and hockey players have previously been investigated. All participants will be outfitted with an adhesive patch-like accelerometer (which will be placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2\_x\_patch/) which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive soccer participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. At each of these time points participants will also undergo various neurocognitive assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collar Group | Experimental | Soccer girls that wore the collar device |
|
| No Collar Group | No Intervention | soccer girls that did not wear the collar |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q Collar | Device | Collar designed to mitigate slosh in the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-season to Post-season DTI Percentage Change | Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity. | 6 months |
| Number of Participants Completing EEG | Number of participants completing EEG | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory D Myer, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinanti Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Collar Group | Soccer girls that wore the collar device Q Collar: Collar designed to mitigate slosh in the brain |
| FG001 | No Collar Group | soccer girls that did not wear the collar |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Collar Group | Soccer girls that wore the collar device Q Collar: Collar designed to mitigate slosh in the brain |
| BG001 | No Collar Group | soccer girls that did not wear the collar |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-season to Post-season DTI Percentage Change | Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity. | Posted | Mean | Standard Deviation | percentage of change | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collar Group | Soccer girls that wore the collar device Q Collar: Collar designed to mitigate slosh in the brain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Foss | Cincinanti Childrens Hospital | 5136365971 | kim.foss@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2018 | Jul 24, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Aug 20, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age of participant | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Completing EEG | Number of participants completing EEG | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | No Collar Group | soccer girls that did not wear the collar | 0 | 28 | 0 | 28 | 0 | 28 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |