Heading in Football: Impact on Neural Blood Biomarkers (HEADLINE)

January 29, 2024 updated by: Prof. dr. Jaap Oosterlaan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

The goal of this observational study is to evaluate the safety of heading in football. We will study the release of biomarkers in blood that reflect microscopic neural damage. The main questions this study aims to answer are:

  • Does participation in a football match lead to a change in biomarkers that reflect microscopic neural damage?
  • Is the dose of exposure during a football match related to the magnitude of change in biomarkers that reflect microscopic neural damage?

Participants will participate in a regular football match and provide blood samples before and right after the football match. The football match will be recorded on video to count the number of headers of all participants.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this prospective observational study is to determine the potential impact of ball heading in football on brain integrity as assessed by blood biomarkers for neural damage in a real-world setting. Healthy amateur football players will be recruited to participate in the study. Participants will be invited to play a regular football match for investigation purposes. They will provide a blood sample within one hour before the start of the match and a second blood sample within one hour after the match. Participants will be asked to provide a third blood sample within 48 hours after participation, but this is not obligatory. The football match will be recorded on video to determine the number of head impacts of all participants. Furthermore, participants will wear heart rate sensors and local positioning sensors to determine the internal and external training load and account for the possible confounding effects of exercise on neural blood biomarkers.

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All senior amateur football players will be invited to participate in the study. An amateur population is chosen because of the great number of participants and the resulting societal relevance of the research question.

Description

Inclusion Criteria:

  • Member of the KNVB;
  • 18 years or older;
  • Male
  • Self-reported fitness to play 70-90 minutes (absence of injury).

Exclusion Criteria:

  • Sustained a head injury in the last year;
  • History or current neurological condition;
  • Regular participation in other contact sports (e.g. rugby, American football, ice hockey, fighting sports);
  • (Former) military personnel with a history of fighting/blast exposure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Soccer
Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study
Other: Head impact exposure
The cohort is exposed to naturalistic head impacts (heading) during voluntary participation in a soccer match. All participants are regular soccer players and are therefore not exposed to excessive head impacts compared to their regular exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of serum neurofilament light protein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum neurofilament light protein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of serum S100B protein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum S100B protein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum p-tau protein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum p-tau protein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum Neuron Specific Enolase protein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum Neuron Specific Enolase protein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum Glial Fibrillary Acidic Protein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum Glial Fibrillary Acidic Protein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum beta-synuclein
Time Frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
The difference in serum beta-synuclein between pre-match samples and post-match samples.
T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Koninklijke Nederlandse VoetbalBond (KNVB)

Investigators

  • Principal Investigator: Jaap Oosterlaan, Prof.Dr., Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL83396.018.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We intend to make IPD available to other researchers. However, we still need to develop the plan in collaboration with the privacy officer and legal research support.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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