Clinical trial NCT06788262: Cerebral and Cognitive Impact of Female Professional SoccerPractice
Official title: Cerebral and Cognitive Modifications in Retired Female Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportswomen : Transverse Analytic Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Chronic Encephalopathy
Keywords: soccer
MRI
head traumatism
neuropsychology
traumatic chronic encephalopathy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 65
Standard ages: ADULT
OLDER_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 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.


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)

Primary outcomes:
measure: Cerebral MRI Microstructural abnormalities
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HOPITAUX UNIVERSITAIRES DE STRASBOURG
name: Stéphane KREMER, MD
role: PRINCIPAL_INVESTIGATOR
References: