Concussion Prevention in Female Soccer Athletes

Concussion, Brain Clinical Trial

Official title:

Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014492
• Other study ID #: 2016-0988
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Concussion, Mild

Intervention

Device:
• Q Collar
Collar designed to mitigate slosh in the brain

Locations

Country	Name	City	State
United States	Cincinanti Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months
Primary	Number of Participants Completing EEG	Number of participants completing EEG	6 months