Concussion Prevention in Female Soccer Athletes

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Collar Group	Q Collar	Soccer girls that wore the collar device

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing EEG	6 months	Number of participants completing EEG
Pre-season to Post-season DTI Percentage Change	6 months	Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.

Secondary Outcome Measures