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Heading in Football: Impact on Neural Blood Biomarkers (HEADLINE)

A

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

Status

Completed

Conditions

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

Treatments

Other: Head impact exposure

Study type

Observational

Funder types

Other

Identifiers

NCT06147596
NL83396.018.23

Details and patient eligibility

About

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.

Full 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.

Enrollment

335 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

335 participants in 1 patient group

Soccer
Description:
Healthy volunteers that participate in the study by playing a regular soccer game for the sake of the HEADLINE study
Treatment:
Other: Head impact exposure

Trial contacts and locations

1

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Central trial contact

Marsh Königs, Dr.; Marloes Hoppen, MSc.

Data sourced from clinicaltrials.gov

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