Heading in Football: Impact on Neural Blood Biomarkers

NCT06147596 | Completed

• 1 other identifier: NL83396.018.23
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heading; Soccer; Head impact; Blood biomarker; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Concentration of serum S100B protein

  T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

• Concentration of serum p-tau protein

  T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

• Concentration of serum Neuron Specific Enolase protein

  T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

• Concentration of serum Glial Fibrillary Acidic Protein

  T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

• Concentration of serum beta-synuclein

  T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

Study Arms (1)

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

Interventions

Head impact exposure 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.

Soccer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Koninklijke Nederlandse VoetbalBond (KNVB): collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood is collected with the possibility of DNA analysis in the future.

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Concussion; Chronic Traumatic Encephalopathy; Nerve Degeneration

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injury, Chronic; Neurodegenerative Diseases; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaap Oosterlaan, Prof.Dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Follow me programme

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: November 27, 2023
• Study Start: August 13, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-01

Locations

NL (1)