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.
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in concentration of neurofilament light
after playing a football match with naturalistic heading exposure.
Secondary outcome
The secondary study parameters are the change in concentration of GFAP, p-Tau,
S100B, NSE and beta-synuclein in blood after playing a football match with
naturalistic heading exposure. Other study parameters are demographic
variables, medical history, heading characteristics, exercise intensity, and
genetic risk factors for neurodegenerative disease.
Background summary
With an estimated 265 million active players around the world, football
(soccer) is the most popular sport worldwide. Football is unique in that it is
the only sport that allows intentional use of the head to play the ball.2 There
is growing concern about possible harmful effects of heading for the brain due
to repetitive head impact, in both amateur and elite football players.
Nevertheless, to date there is limited evidence for either acute or cumulative
effects of heading on the brain of active football players. Biomarkers of
neural damage have proven diagnostic value for brain damage caused by traumatic
brain injury and neurodegenerative disease, and therefore represent a promising
method to investigate the impact of heading exposure on brain integrity.
Existing studies lack sufficient sample sizes to detect small effects and have
often not assessed a realistic exposure to ball heading in a real-world
setting. Moreover, the biomedical field has recently brought forward novel and
biomarkers of neural damage. Taken together, the field is in need of
longitudinal studies that investigate the impact of a naturalistic ball heading
exposure on brain integrity with substantial sample sizes.
Study objective
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.
Study design
A prospective observational study
Study burden and risks
Burden
Participants will be requested to participate in the following measurements:
1. Fill in an intake questionnaire (duration: 10 minutes)
2. Provide 2-3 blood samples of 14-20 ml, in total 34-48ml (duration: 20-35
minutes)
3. Play a football match while wearing a Local Positioning System sensor and
heart rate sensor (duration: 105 minutes)
Risks and benefits
The risks of participation in this observational study are considered
negligible (also see attachment *Risk Assessment*). Participants do not have a
direct benefit of participation.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
- Member of the KNVB
- 18 years or older
- Male
- Self-reported fitness to play 70-90 minutes
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83396.018.23 |