Cerebral and Cognitive Impact of Professional Soccer Practice
TC-FOOT
Cerebral and Cognitive Modifications in Retired Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportsmen : Transverse Analytic Study
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
January 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2026
CompletedAugust 8, 2025
August 1, 2025
4.1 years
May 10, 2021
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
This is a study assessing the relation between exposure to mild head injuries during soccer play in professional players and the onset of MRI and neuropsychological abnormalities. The main evaluation criterion corresponds to the quantitative MRI modifications (professional soccer player group compared with control group).
day 1
Secondary Outcomes (10)
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
day 1
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
day 1
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
day 1
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
day 1
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
day 1
- +5 more secondary outcomes
Study Arms (2)
professional Soccer players
EXPERIMENTALathletes not exposed to head injuries.
ACTIVE COMPARATORInterventions
The following sequences of the MRI will be acquired during the inclusion visit: * 3D T1 gradient echo (GRE): anatomy; registration; cerebral, white matter, and grey matter volumetry; and cortical thickness; * multiecho 3D T2 GRE: quantitative susceptibility mapping (QSM), iron overload quantification; * continuous arterial spin labeling (ASL) 3D: cerebral perfusion; * resting-state fMRI: functional connectivity; * 64-direction DTI (b=1000 and 2500): alterations in white matter and its microstructure, anatomic connectivity; * monovoxel spectroscopy of the mesencephalus with short echo time (TE).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
Related Publications (1)
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.
PMID: 36351716DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane KREMER, MD
Hôpitaux Universitaires de Strasbourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 26, 2021
Study Start
January 7, 2022
Primary Completion
February 7, 2026
Study Completion
February 7, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08