Skip to main content
OpenTrials
Completed

NCT Number: NCT06147596

Heading in Football: Impact on Neural Blood Biomarkers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head Injury, Minor Brain Concussion Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury, Chronic CTE - Chronic Traumatic Encephalopathy Central Nervous System Diseases Chronic Disease Chronic Traumatic Encephalopathy Concussion, Mild Craniocerebral Trauma Disease Attributes Head Injuries, Closed Nerve Degeneration Nervous System Diseases Neurodegeneration Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Koninklijke Nederlandse VoetbalBond (KNVB)

Registry information

Acronym: HEADLINE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.