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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03014492
Other study ID # 2016-0988
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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