" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device " (NCT04426188) | Clinical Trial Compass
CompletedNot Applicable
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
France21 participantsStarted 2020-06-04
Plain-language summary
Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired
Who can participate
Age range
18 Years – 25 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux
Exclusion Criteria:
* Abnormal neurological examination
* Taking drugs targeting the central nervous system
* Any unhealed injury
* History of head trauma, or other notion of central nervous system injury
* History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
* Family history of epilepsy
* Contraindication to MRI: head circumference\> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body - refusal to be informed of an anomaly detected with MRI
* Individuals under legal protection or unable of giving their informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied repetitive soccer headers and measured head acceleration — if I or my child plays soccer, what do the findings from this kind of research mean for our actual risk of brain injury over time?
2The trial tested a protective device to see if it reduces head acceleration during headers — does my doctor know whether the results showed any meaningful difference, and is that device something worth considering for our situation?
3Since this was a Phase N/A study focused on measuring brain changes rather than treating an injury, does my doctor think the findings change any recommendations about how often heading should be practiced or limited?
4This trial is now completed — does my doctor have access to the published results, and do those results affect how they'd approach monitoring or managing someone who has done repetitive headers over many years?
5Given that this research was about sub-concussive impacts rather than full concussions, should I be discussing brain health screening with my doctor even if I've never been officially diagnosed with a concussion?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.