Concussion Prevention in Female Soccer Athletes
Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 4, 2020
September 1, 2020
1.5 years
January 5, 2017
July 24, 2020
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Collar Group
EXPERIMENTALSoccer girls that wore the collar device
No Collar Group
NO INTERVENTIONsoccer girls that did not wear the collar
Interventions
Eligibility Criteria
You may qualify if:
- Female
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on a high school soccer team
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Foss
- Organization
- Cincinanti Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Myer, PhD
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 9, 2017
Study Start
June 1, 2016
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
November 4, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-09