Cerebral and Cognitive Impact of Female Professional SoccerPractice

NCT ID: NCT06788262

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-06-15

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.

Conditions

Traumatic Chronic Encephalopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Female professional Soccer players

Diagnostic 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).

Group Type: EXPERIMENTAL

Cerebral MRI

Intervention Type: OTHER

Cerebral MRI

Female athletes not exposed to head injuries.

Diagnostic 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).

Group Type: ACTIVE_COMPARATOR

Cerebral MRI

Intervention Type: OTHER

Cerebral MRI

Interventions

Cerebral MRI

Cerebral MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane KREMER, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAUX UNIVERSITAIRES DE STRASBOURG

Central Contacts

Stéphane KREMER, MD

Role: CONTACT

stephane.kremer@chru-strasbourg.fr

03 88 12 78 48 ext. 0033

Other Identifiers

9414

Identifier Type: -

Identifier Source: org_study_id