Back to resultsCerebral and Cognitive Impact of Professional Soccer Practice (TC-FOOT)
Primary Purpose
Traumatic Chronic Encephalopathy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional screening trial for Traumatic Chronic Encephalopathy focused on measuring traumatic chronic encephalopathy, soccer, MRI, neuropsychology, head traumatism
Eligibility Criteria
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);
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
professional Soccer players
athletes not exposed to head injuries.
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.)
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)
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)
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)
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)
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)
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)
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)
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
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
Full Information
NCT ID
NCT04903015
First Posted
May 10, 2021
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04903015
Brief Title
Cerebral and Cognitive Impact of Professional Soccer Practice
Acronym
TC-FOOT
Official Title
Cerebral and Cognitive Modifications in Retired Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportsmen : Transverse Analytic Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
February 7, 2025 (Anticipated)
Study Completion Date
February 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Chronic Encephalopathy
Keywords
traumatic chronic encephalopathy, soccer, MRI, neuropsychology, head traumatism
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
professional Soccer players
Arm Type
Experimental
Arm Title
athletes not exposed to head injuries.
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
day 1
Secondary Outcome Measure Information:
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
RL RI 16 items (Van der Linden, 2001) to assess the functioning of verbal episodic memory (= 25 min.)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
Memory reproduction of Rey's complex figure in order to assess episodic visual memory (Rey Osterrieth, 1941) (= 20 min)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
Verbal and visuo-spatial auditory empans (Wechsler scale Memory form III, 1997) to assess short-term memory and working memory (= 5 min)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
Copy of Rey's complex figure (Rey-Osterrieth, 1941) assessing visual-constructive abilities and planning (= 5 min)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
The Brixton Test, a spatial anticipation task that also evaluates executive functioning (Burgess P.W. & Shallice T. (1996) (= 15 min)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
Trail Making Test A and B (Reitan et al., 1950) assessing treatment speed and mental flexibility (= 5 min)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
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)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
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)
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
A BRIEF-A (Behavioural Evaluation Inventory of Executive Functions - Adult Version): 10min
Time Frame
day 1
Title
The cognitive impact of repeated mild head injuries via a neuropsychological evaluation by neurophysiological tests: number of errors and time to complete tests
Description
Research into recurrent symptoms such as headache (seniority, frequency), fatigability, sleep disturbance, dizziness, blurred vision, photo-phonophobia
Time Frame
day 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane KREMER, MD
Phone
03 88 12 78 48
Ext
0033
Email
stephane.kremer@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane KREMER, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane KREMER, MD
Phone
03 88 12 78 48
Ext
0033
Email
stephane.kremer@chru-strasbourg.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
36351716
Citation
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.
Results Reference
derived
Learn more about this trial
Cerebral and Cognitive Impact of Professional Soccer Practice
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