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Traumatic Chronic EncephalopathyTC-FOOTNCT04903015

Cerebral and Cognitive Impact of Professional Soccer Practice

A study testing MRI in people with Traumatic Chronic Encephalopathy, run by University Hospital, Strasbourg, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 32 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Traumatic Chronic Encephalopathy
What is being tested?
MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
7 Jan 2022to 7 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stéphane KREMER, MD contact

03 88 12 78 48 ext. 0033

stephane.kremer@chru-strasbourg.fr

France1 site, 1 recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000

    Stéphane KREMER, MD, 03 88 12 78 48 ext. 0033, stephane.kremer@chru-strasbourg.fr

    Recruiting

Other trials in France

About this study

Official title: Cerebral and Cognitive Modifications in Retired Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportsmen : Transverse Analytic Study

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.

Being tested
MRI
Keywords
traumatic chronic encephalopathy, soccer, MRI, neuropsychology, head traumatism
Medical subject headings
Chronic Traumatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).
Study groups in NCT04903015
Study groupRoleWhat they receive
professional Soccer playersExperimentalNot described
Receives: Diagnostic Test: MRI
athletes not exposed to head injuries.Active comparatorNot described
Receives: Diagnostic Test: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: day 1

Secondary outcomes (10)

  1. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    RL RI 16 items (Van der Linden, 2001) to assess the functioning of verbal episodic memory (= 25 min.)

    Measured: day 1

  2. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Memory reproduction of Rey's complex figure in order to assess episodic visual memory (Rey Osterrieth, 1941) (= 20 min)

    Measured: day 1

  3. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Verbal and visuo-spatial auditory empans (Wechsler scale Memory form III, 1997) to assess short-term memory and working memory (= 5 min)

    Measured: day 1

  4. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Copy of Rey's complex figure (Rey-Osterrieth, 1941) assessing visual-constructive abilities and planning (= 5 min)

    Measured: day 1

  5. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    The Brixton Test, a spatial anticipation task that also evaluates executive functioning (Burgess P.W. \& Shallice T. (1996) (= 15 min)

    Measured: day 1

  6. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Trail Making Test A and B (Reitan et al., 1950) assessing treatment speed and mental flexibility (= 5 min)

    Measured: day 1

  7. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Computerized attention tests will also be used to measure reaction times and also executive aspects (Phasic Alert, Split Attention and Zimmermann APR Incompatibility version 2.1, 2009) (= 15 min)

    Measured: day 1

  8. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Social cognition test Reading the Mind in the eyes assessing the ability to read the emotions of others which, in turn, is related to pSocial cognition test Reading the Mind in the eyes assessing the ability to read the emotions of others which, in turn, is related to performance in team problem-solving tasks (Baron-Cohen; 2001) ( = 10 min)

    Measured: day 1

  9. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    A BRIEF-A (Behavioural Evaluation Inventory of Executive Functions - Adult Version): 10min

    Measured: day 1

  10. The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests

    Research into recurrent symptoms such as headache (seniority, frequency), fatigability, sleep disturbance, dizziness, blurred vision, photo-phonophobia

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start7 Jan 2022
  3. Primary completion7 Feb 2026 (estimated)
  4. Study completion7 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903015
Sponsor's protocol ID
8077
Acronym
TC-FOOT
Status last verified
Aug 2025
First submitted
10 May 2021
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36351716

Questions about this trial

What is this clinical trial studying?

A study testing MRI in people with Traumatic Chronic Encephalopathy, run by University Hospital, Strasbourg, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stéphane KREMER, MD (03 88 12 78 48 ext. 0033, stephane.kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04903015, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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