NCT05457023

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

July 28, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

July 7, 2022

Last Update Submit

November 9, 2023

Conditions

Keywords

Soccer, Heading, Omega-3, Neurofilament Light, Subconcussive, Women

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Collegiate Women Soccer Players

National Collegiate Athletic Association (NCAA) players.

Other: Plasma Neurofilament Light (NF-L)Other: Omega-3 IndexOther: HeadCount Questionnaire

Interventions

Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.

Collegiate Women Soccer Players

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.

Collegiate Women Soccer Players

HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.

Collegiate Women Soccer Players

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Collegiate women soccer players who actively compete at the NCAA Division 1-A competition level.

You may qualify if:

  • 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.

You may not qualify if:

  • Is recovering from a Physician diagnosed concussion.
  • Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Missouri Kansas City

Kansas City, Missouri, 64108, United States

Location

Rockhurst University

Kansas City, Missouri, 64110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Brain Injuries, TraumaticCharcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Aaron F Carbuhn, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 13, 2022

Study Start

July 28, 2022

Primary Completion

November 9, 2023

Study Completion

November 9, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations