HEADLINE: Heading in Football: Impact on Neural Blood Biomarkers

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT06147596

Collaborator

Koninklijke Nederlandse VoetbalBond (KNVB) (Other)

280

Enrollment

29.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head Injury, Minor Concussion, Mild CTE - Chronic Traumatic Encephalopathy Neurodegeneration	Other: Head impact exposure

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 Design

Study Type:

Observational

Anticipated Enrollment :

280 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Heading in Football: Impact on Neural Blood Biomarkers

Anticipated Study Start Date :

Nov 18, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Concentration of serum neurofilament light protein [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.

Secondary Outcome Measures

Concentration of serum S100B protein [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.
Concentration of serum p-tau protein [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.
Concentration of serum Neuron Specific Enolase protein [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.
Concentration of serum Glial Fibrillary Acidic Protein [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.
Concentration of serum beta-synuclein [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

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