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Concussion Prevention in Female Soccer Athletes

Primary Purpose

Concussion, Mild, Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Q Collar
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Mild

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Normal healthy volunteer
  • Able to provide written consent
  • Must be 14 years or older and a participant on a high school soccer team

Exclusion Criteria:

  • Unable to provide written consent
  • History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
  • Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
  • Glaucoma (Narrow Angle or Normal Tension)
  • Hydrocephalus
  • Recent penetrating brain trauma (within 6 months)
  • Known carotid hypersensitivity
  • Known increased intracranial pressure
  • Central vein thrombosis
  • Any known airway obstruction
  • Any known seizure disorder

Sites / Locations

  • Cincinanti Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collar Group

No Collar Group

Arm Description

Soccer girls that wore the collar device

soccer girls that did not wear the collar

Outcomes

Primary Outcome Measures

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.
Number of Participants Completing EEG
Number of participants completing EEG

Secondary Outcome Measures

Full Information

First Posted
January 5, 2017
Last Updated
October 13, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03014492
Brief Title
Concussion Prevention in Female Soccer Athletes
Official Title
Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Concussion, Brain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collar Group
Arm Type
Experimental
Arm Description
Soccer girls that wore the collar device
Arm Title
No Collar Group
Arm Type
No Intervention
Arm Description
soccer girls that did not wear the collar
Intervention Type
Device
Intervention Name(s)
Q Collar
Intervention Description
Collar designed to mitigate slosh in the brain
Primary Outcome Measure Information:
Title
Pre-season to Post-season DTI Percentage Change
Description
Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
Time Frame
6 months
Title
Number of Participants Completing EEG
Description
Number of participants completing EEG
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Normal healthy volunteer Able to provide written consent Must be 14 years or older and a participant on a high school soccer team Exclusion Criteria: Unable to provide written consent History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening: Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) Glaucoma (Narrow Angle or Normal Tension) Hydrocephalus Recent penetrating brain trauma (within 6 months) Known carotid hypersensitivity Known increased intracranial pressure Central vein thrombosis Any known airway obstruction Any known seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinanti Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Concussion Prevention in Female Soccer Athletes

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