NCT04903015 Cerebral and Cognitive Impact of Professional Soccer Practice
| NCT ID | NCT04903015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Traumatic Chronic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-01-07 |
| Primary Completion | 2026-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-01-07 with a primary completion date of 2026-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to evaluate, using MRI, the microstructural consequences and the onset of any cognitive impairment in professional soccer players at the end of their career, who have experienced repeated minor head injuries. Over the long term, these head injuries could lead to morphological lesions and have an impact on soccer players' cognitive skills. The main evaluation criterion corresponds to the modifications found on MRI in the professional soccer player group (diffusion tensor, cerebral perfusion, fMRI, cerebral volumetry and cortical thickness, spectroscopy, susceptibility imaging). This is an exposure/nonexposure study assessing the onset of MRI abnormalities (diffusion tensor, cerebral perfusion, fMRI, volumetry and cortical thickness, spectroscopy, susceptibility imaging) in professional soccer players exposed to repeated mild head injuries, who are either at the end of their career or retired for approximately 10 years, compared to high-level athletes not exposed to head injuries.
Eligibility Criteria
Inclusion Criteria: Exposed high-level athletes: professional soccer players at the end of their career (32- years old) playing in France Ligue 1 or 2 exposed to repeated mild head injuries with no history of severe head injury or cerebral lesion; -High-level athletes not exposed to repeated mild head injuries: control group paired for age with professional soccer players, who have never regularly participated in sports exposing them to head injuries (notably rugby, basketball, handball, American football, hockey, combat sports, etc.) and who have no history of head injury, even mild. Professional tennis players or former players will be preferentially recruited. Exclusion Criteria: * Refusal to participate in the study; * refusal to be informed of abnormalities on MRI * Incapacity to give informed consent or under a legal protection order; * History of cerebral concussion including the presence after head shock of one or more of the following signs or symptoms: a period of confusion or disorientation, a period of loss of consciousness of 30 minutes or less, post-traumatic amnesia not exceeding 24 hours * History of severe head/brain injury; * History of neurological or psychiatric disorder; * Known cerebral abnormality diagnosed by an imaging exam (CT or MRI); * History or regular or occasional consumption of drugs, unweaned active smoking or weaned for less than 1 year, excessive consumption of alcohol (\> 20 g alcohol per day, evaluated with the formula "degree of alcohol × volume in cl × 8/1000"), weaned or not. * Usage of medication targeting the central nervous system in the 2 weeks preceding inclusion in the study; * Prior history of severe hypertension, diabetes, chronic heart disease, progressive or disabling disease; * Contraindication to MRI (claustrophobia, implanted material not compatible with MRI, refusal to be informed of abnormality discovered on MRI);
Contact & Investigator
Stéphane KREMER, MD
PRINCIPAL INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Frequently Asked Questions
Who can join the NCT04903015 clinical trial?
This trial is open to male participants only, aged 32 Years or older, up to 55 Years, studying Traumatic Chronic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04903015 currently recruiting?
Yes, NCT04903015 is actively recruiting participants. Contact the research team at stephane.kremer@chru-strasbourg.fr for enrollment information.
Where is the NCT04903015 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT04903015 clinical trial?
NCT04903015 is sponsored by University Hospital, Strasbourg, France. The principal investigator is Stéphane KREMER, MD at Hôpitaux Universitaires de Strasbourg. The trial plans to enroll 80 participants.