Brain TraumaNCT05457023
Plasma Neurofilament Light and Its Relationship With Omega-3 Status and Soccer Heading in Women Soccer Players
An observational study of Brain Trauma, run by University of Kansas Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Trauma
- What is being tested?
- Plasma Neurofilament Light (NF-L), Omega-3 Index and HeadCount Questionnaire
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2022to 9 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Collegiate women soccer players who actively compete at the NCAA Division 1-A competition level.
Who may be able to join
- 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.
Who cannot join
- Is recovering from a Physician diagnosed concussion.
- Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Missouri Kansas City
Kansas City, Missouri, 64108
Rockhurst University
Kansas City, Missouri, 64110
About this study
Official title: A Blood Biomarker for Sports-Related Brain Injury and Its Relationship With Omega-3 Status and Purposeful Soccer Heading in Free-Living Collegiate Women Soccer Players During and After a Competitive Season
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.
- Conditions
- Brain Trauma
- Being tested
- Plasma Neurofilament Light (NF-L), Omega-3 Index, HeadCount Questionnaire
- Keywords
- Soccer, Heading, Omega-3, Neurofilament Light, Subconcussive, Women
- Medical subject headings
- Brain Injuries, Traumatic, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Neurofilament Light (NF-L)Other
Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.
Omega-3 IndexOther
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 QuestionnaireOther
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.
| Study group | Role | What they receive |
|---|---|---|
| Collegiate Women Soccer Players | National Collegiate Athletic Association (NCAA) players. Receives: Other: Plasma Neurofilament Light (NF-L); Other: Omega-3 Index; Other: HeadCount Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start28 Jul 2022
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TraumaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Carbuhn, University of Kansas Medical Center
- Investigators
- Aaron F Carbuhn, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457023
- Sponsor's protocol ID
- STUDY00148618
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blood Biomarker for Sports-Related Brain Injury and Its Relationship With Omega-3 Status and Purposeful Soccer Heading in Free-Living Collegiate Women Soccer Players During and After a Competitive Season
- ClinicalTrials.gov ID
- NCT05457023
- Acronym / sponsor ID
- STUDY00148618
- Conditions
- Brain Trauma
- Keywords
- Soccer, Heading, Omega-3, Neurofilament Light, Subconcussive, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collegiate Women Soccer Players | – | Other: Plasma Neurofilament Light (NF-L), Other: Omega-3 Index, Other: HeadCount QuestionnaireNational Collegiate Athletic Association (NCAA) players. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Collegiate women soccer players who actively compete at the NCAA Division 1-A competition level.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Is recovering from a Physician diagnosed concussion.
- Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Neurofilament Light (NF-L)Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts. | Other | Collegiate Women Soccer Players |
| Omega-3 IndexOmega-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. | Other | Collegiate Women Soccer Players |
| HeadCount QuestionnaireHeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly. | Other | Collegiate Women Soccer Players |
Primary outcome
Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season.
Time frame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Plasma neurofilament light (pg/mL) is a biomarker of axonal brain injury following sports-related head impacts.
Change in purposeful soccer heading frequencies from baseline, during, and after a competitive season.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading frequencies (#) during competitive play and is administered bi-weekly.
Change in Omega-3 status from baseline, during, and after a competitive season.
Time frame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron F Carbuhn, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Trauma, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season. (time frame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.