Concussion Prevention in Female Soccer Athletes

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Concussion, Mild; Concussion, Brain

Treatments: Device: Q Collar

Study type: Interventional

Funder types: Other

Identifiers

NCT03014492

2016-0988

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: Female

Ages: 14 to 19 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Collar Group

Experimental group

Description:

Soccer girls that wore the collar device

Treatment:

Device: Q Collar

No Collar Group

No Intervention group

Description:

soccer girls that did not wear the collar