Head Injury, MinorHEADLINENCT06147596
Heading in Football: Impact on Neural Blood Biomarkers
An observational study of Head Injury, Minor and Concussion, Mild, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Head Injury, Minor, Concussion, Mild, CTE - Chronic Traumatic Encephalopathy
- What is being tested?
- Head impact exposure
- How many people
- 335 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Aug 2024to 17 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Member of the KNVB;
- 18 years or older;
- Male
- Self-reported fitness to play 70-90 minutes (absence of injury).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Head Injury, Minor, Concussion, Mild, CTE - Chronic Traumatic Encephalopathy, Neurodegeneration
- Being tested
- Head impact exposure
- Keywords
- Heading, Soccer, Head impact, Blood biomarker, Neurodegeneration
- Medical subject headings
- Craniocerebral Trauma, Brain Concussion, Chronic Traumatic Encephalopathy, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head impact exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Soccer | Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study Receives: Other: Head impact exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum neurofilament light protein
The difference in serum neurofilament light protein between pre-match samples and post-match samples.
Measured: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Secondary outcomes (5)
Concentration of serum S100B protein
The difference in serum S100B protein between pre-match samples and post-match samples.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start13 Aug 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury, MinorStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Koninklijke Nederlandse VoetbalBond (KNVB)
- Responsible party
- Principal investigator, Prof. dr. Jaap Oosterlaan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jaap Oosterlaan, Prof.Dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147596
- Sponsor's protocol ID
- NL83396.018.23
- Acronym
- HEADLINE
- Status last verified
- Jan 2025
- First submitted
- 5 Oct 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to make IPD available to other researchers. However, we still need to develop the plan in collaboration with the privacy officer and legal research support.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heading in Football: Impact on Neural Blood Biomarkers
- ClinicalTrials.gov ID
- NCT06147596
- Acronym / sponsor ID
- HEADLINE / NL83396.018.23
- Conditions
- Head Injury, Minor, Concussion, Mild, CTE - Chronic Traumatic Encephalopathy, Neurodegeneration
- Keywords
- Heading, Soccer, Head impact, Blood biomarker, Neurodegeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Koninklijke Nederlandse VoetbalBond (KNVB)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soccer | – | Other: Head impact exposureHealthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Member of the KNVB;
- 18 years or older;
- Male
- Self-reported fitness to play 70-90 minutes (absence of injury).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head impact exposureThe 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. | Other | Soccer |
Primary outcome
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.
5 secondary outcomes
Concentration of serum S100B protein
Time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum p-tau protein
Time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum Neuron Specific Enolase protein
Time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum Glial Fibrillary Acidic Protein
Time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Concentration of serum beta-synuclein
Time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided. We intend to make IPD available to other researchers. However, we still need to develop the plan in collaboration with the privacy officer and legal research support.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Oosterlaan, Prof.Dr. principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury, Minor and Concussion, Mild, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum neurofilament light protein (time frame: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.