Heading in Football: Impact on Neural Blood Biomarkers

Concussion, Mild Clinical Trial

— HEADLINE  

Official title:

Heading in Football: Impact on Neural Blood Biomarkers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147596
• Other study ID #: NL83396.018.23
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Marloes Hoppen, MSc.
• Phone: 00312056 62008
• Email: m.i.hoppen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: May 1, 2026
• Est. primary completion date: October 1, 2025
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Diseases
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy
• Concussion, Mild
• Craniocerebral Trauma
• Head Injury, Minor
• Nerve Degeneration
• Neurodegeneration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Koninklijke Nederlandse VoetbalBond (KNVB)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)