NCT06788262

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

January 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

January 16, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

soccerMRIhead traumatismneuropsychologytraumatic chronic encephalopathy

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

EXPERIMENTAL

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).

Other: Cerebral MRI

Female athletes not exposed to head injuries.

ACTIVE COMPARATOR

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).

Other: Cerebral MRI

Interventions

Cerebral MRI

Female athletes not exposed to head injuries.Female professional Soccer players

Eligibility Criteria

Age32 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Chronic Traumatic Encephalopathy

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Injury, ChronicNeurodegenerative DiseasesCraniocerebral TraumaTrauma, Nervous SystemBrain Damage, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Stéphane KREMER, MD

    HOPITAUX UNIVERSITAIRES DE STRASBOURG

    PRINCIPAL INVESTIGATOR

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