- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04903015
Cerebral and Cognitive Impact of Professional Soccer Practice (TC-FOOT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stéphane KREMER, MD
- Phone Number: 0033 03 88 12 78 48
- Email: stephane.kremer@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67000
- Recruiting
- Hôpitaux Universitaires de Strasbourg
-
Contact:
- Stéphane KREMER, MD
- Phone Number: 0033 03 88 12 78 48
- Email: stephane.kremer@chru-strasbourg.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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);
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: professional Soccer players
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The following sequences of the MRI will be acquired during the inclusion visit:
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Active Comparator: athletes not exposed to head injuries.
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The following sequences of the MRI will be acquired during the inclusion visit:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
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day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Time Frame: day 1
|
RL RI 16 items (Van der Linden, 2001) to assess the functioning of verbal episodic memory (= 25 min.)
|
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
Time Frame: day 1
|
Memory reproduction of Rey's complex figure in order to assess episodic visual memory (Rey Osterrieth, 1941) (= 20 min)
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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
Time Frame: day 1
|
Verbal and visuo-spatial auditory empans (Wechsler scale Memory form III, 1997) to assess short-term memory and working memory (= 5 min)
|
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
Time Frame: day 1
|
Copy of Rey's complex figure (Rey-Osterrieth, 1941) assessing visual-constructive abilities and planning (= 5 min)
|
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
Time Frame: day 1
|
The Brixton Test, a spatial anticipation task that also evaluates executive functioning (Burgess P.W. & Shallice T. (1996) (= 15 min)
|
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
Time Frame: day 1
|
Trail Making Test A and B (Reitan et al., 1950) assessing treatment speed and mental flexibility (= 5 min)
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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
Time Frame: day 1
|
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)
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day 1
|
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The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Time Frame: day 1
|
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)
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day 1
|
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The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Time Frame: day 1
|
A BRIEF-A (Behavioural Evaluation Inventory of Executive Functions - Adult Version): 10min
|
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
Time Frame: day 1
|
Research into recurrent symptoms such as headache (seniority, frequency), fatigability, sleep disturbance, dizziness, blurred vision, photo-phonophobia
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day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Stéphane KREMER, MD, Hôpitaux Universitaires de Strasbourg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8077 (CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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