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Cerebral and Cognitive Impact of Professional Soccer Practice (TC-FOOT)

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Traumatic Chronic Encephalopathy

Treatments

Diagnostic Test: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04903015
8077 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Male

Ages

32 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

  • 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.
  • 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);

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

professional Soccer players
Experimental group
Treatment:
Diagnostic Test: MRI
athletes not exposed to head injuries.
Active Comparator group
Treatment:
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

Stéphane KREMER, MD

Data sourced from clinicaltrials.gov

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