NCT04903015

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

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2026

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

May 10, 2021

Last Update Submit

August 4, 2025

Conditions

Keywords

traumatic chronic encephalopathysoccerMRIneuropsychologyhead traumatism

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

EXPERIMENTAL
Diagnostic Test: MRI

athletes not exposed to head injuries.

ACTIVE COMPARATOR
Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

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).

athletes not exposed to head injuries.professional Soccer players

Eligibility Criteria

Age32 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

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.

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

    Hôpitaux 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

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

Locations