Cerebral and Cognitive Impact of Female Professional SoccerPractice
TCFOOT F
Cerebral and Cognitive Modifications in Retired Female Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportswomen : Transverse Analytic Study
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The objective of this study is to evaluate, using MRI, the microstructural consequences and the onset of any cognitive impairment in female 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 female soccer players' cognitive skills. The main evaluation criterion corresponds to the modifications found on MRI in the female 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 female 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 Sep 2025
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
January 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2027
August 5, 2025
August 1, 2025
1.7 years
January 16, 2025
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebral MRI Microstructural abnormalities
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
Study Arms (2)
Female professional Soccer players
EXPERIMENTALDiagnostic Test: MRI 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).
Female athletes not exposed to head injuries.
ACTIVE COMPARATORDiagnostic Test: MRI 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).
Interventions
Cerebral MRI
Eligibility Criteria
You may qualify if:
- Exposed high-level athletes: female 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
- Female High-level athletes not exposed to repeated mild head injuries: control group paired for age with female 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. Female Professional tennis players or former players will be preferentially recruited.
You may not qualify if:
- 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane KREMER, MD
HOPITAUX 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
January 16, 2025
First Posted
January 23, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
June 15, 2027
Last Updated
August 5, 2025
Record last verified: 2025-08