Heading in Football: Impact on Neural Blood Biomarkers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Heading in Football: Impact on Neural Blood Biomarkers

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

Intervention / Treatment
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* Other: Head impact exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Soccer<br>Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study | Other: Head impact exposure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of serum neurofilament light protein | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heading, Soccer, Head impact, Blood biomarker, Neurodegeneration