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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05457023
Other study ID # STUDY00148618
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2022
Est. completion date November 9, 2023

Study information

Verified date November 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to (1) assess how a competitive season of purposeful gameplay soccer heading in collegiate women soccer players is related to a blood biomarker for sports-related brain injury, plasma neurofilament light (NF-L), and (2) examine how a player's omega-3 status is related to plasma NF-L concentration changes during and after a competitive season of gameplay soccer heading.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 9, 2023
Est. primary completion date November 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - At least 18 years of age. - Active player on the university's current team roster for the upcoming competitive season. - Is eligible to participate in games and is not redshirting. Exclusion Criteria: - Is recovering from a Physician diagnosed concussion. - Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plasma Neurofilament Light (NF-L)
Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.
Omega-3 Index
Omega-3 Index is the omega-3 fatty acid content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) within the erythrocyte cell membrane. It is expressed as EPA+DHA as a percent of total identified fatty acids.
HeadCount Questionnaire
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.

Locations

Country Name City State
United States Rockhurst University Kansas City Missouri
United States University of Missouri Kansas City Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season. Plasma neurofilament light (pg/mL) is a biomarker of axonal brain injury following sports-related head impacts. Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Primary Change in purposeful soccer heading frequencies from baseline, during, and after a competitive season. HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading frequencies (#) during competitive play and is administered bi-weekly. Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks
Primary Change in Omega-3 status from baseline, during, and after a competitive season. Omega-3 Index (%) is the omega-3 fatty acid content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) within membrane of red blood cell. It is expressed as EPA+DHA as a percent of total identified fatty acids. Baseline, 1 Months, 2 Months, 3 Months, 6 Months
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