Traumatic Chronic EncephalopathyTCFOOT FNCT06788262
Cerebral and Cognitive Impact of Female Professional SoccerPractice
A study testing Cerebral MRI in people with Traumatic Chronic Encephalopathy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Traumatic Chronic Encephalopathy
- What is being tested?
- Cerebral MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2025to 15 Jun 2027
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 10Show fewer
- 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.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Stéphane KREMER, MD, 03 88 12 78 48 ext. 0033, stephane.kremer@chru-strasbourg.fr
Stéphane Kremer, MD
About this study
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
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.
- Conditions
- Traumatic Chronic Encephalopathy
- Being tested
- Cerebral MRI
- Keywords
- soccer, MRI, head traumatism, neuropsychology, traumatic chronic encephalopathy
- 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.
Cerebral MRIOther
Cerebral MRI
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Cerebral MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start13 Sep 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Chronic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane KREMER, MD, Principal investigator, HOPITAUX UNIVERSITAIRES DE STRASBOURG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788262
- Sponsor's protocol ID
- 9414
- Acronym
- TCFOOT F
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06788262
- Acronym / sponsor ID
- TCFOOT F / 9414
- Conditions
- Traumatic Chronic Encephalopathy
- Keywords
- soccer, MRI, head traumatism, neuropsychology, traumatic chronic encephalopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Sep 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female professional Soccer players | Experimental | Other: Cerebral MRIDiagnostic 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). |
| Female athletes not exposed to head injuries. | Active comparator | Other: Cerebral MRIDiagnostic 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). |
Who may qualify
- Ages
- 32 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral MRICerebral MRI | Other | Female athletes not exposed to head injuries., Female professional Soccer players |
Primary outcome
Cerebral MRI Microstructural abnormalities
Time frame: Day 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane KREMER, MD principal investigator
HOPITAUX UNIVERSITAIRES DE STRASBOURG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral 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 10 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 20 Aug 2026. 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?
Cerebral MRI Microstructural abnormalities (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.