Clinical trial NCT04903015: Cerebral and Cognitive Impact of Professional Soccer Practice
Official title: Cerebral and Cognitive Modifications in Retired Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportsmen : Transverse Analytic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Chronic Encephalopathy
Keywords: traumatic chronic encephalopathy
soccer
MRI
neuropsychology
head traumatism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 80
Sex: MALE
Minimum age (years): 32
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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);

Primary outcomes:
measure: Abnormalities on MRI in professional soccer players exposed to repeated mild head injuries, potentially related to chronic traumatic encephalopathy, compared to high-level athletes who are not exposed to head injuries.
timeFrame: day 1
Secondary outcomes:
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
measure: The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
timeFrame: day 1
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Stéphane KREMER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kepka S, Lersy F, Godet J, Blanc F, Bilger M, Botzung A, Kleitz C, Merignac J, Ohrant E, Garnier F, Pietra F, Noblet V, Deck C, Willinger R, Kremer S. Cerebral and cognitive modifications in retired professional soccer players: TC-FOOT protocol, a transverse analytical study. BMJ Open. 2022 Nov 9;12(11):e060459. doi: 10.1136/bmjopen-2021-060459.