Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Koninklijke Nederlandse VoetbalBond (KNVB) | UNKNOWN |
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soccer | Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaap Oosterlaan, Prof.Dr. | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | 1105AZ | Netherlands |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D001924 | Brain Concussion |
| D000070627 | Chronic Traumatic Encephalopathy |
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D000070642 | Brain Injuries, Traumatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood is collected with the possibility of DNA analysis in the future.
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) |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D020208 | Brain Injury, Chronic |
| D019636 | Neurodegenerative Diseases |
| D001925 | Brain Damage, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |