Heading in Football: Impact on Neural Blood Biomarkers

NCT ID: NCT06147596

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 335 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2024-12-17

Brief Summary

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.

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.

Conditions

Head Injury, Minor; Concussion, Mild; CTE - Chronic Traumatic Encephalopathy; Neurodegeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Soccer

Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study

Head impact exposure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Koninklijke Nederlandse VoetbalBond (KNVB)

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. Jaap Oosterlaan

Director Follow me programme

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaap Oosterlaan, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL83396.018.23

Identifier Type: -

Identifier Source: org_study_id