- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06788262
Cerebral and Cognitive Impact of Female Professional SoccerPractice (TCFOOT F)
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.
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
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 |
|---|---|
|
Experimental: Female professional Soccer players
Diagnostic Test: MRI The following sequences of the MRI will be acquired during the inclusion visit:
|
Cerebral MRI
|
|
Active Comparator: Female athletes not exposed to head injuries.
Diagnostic Test: MRI The following sequences of the MRI will be acquired during the inclusion visit:
|
Cerebral MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropsychological abnormalities
Time Frame: 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 RL RI 16 items (Van der Linden, 2001) to assess the functioning of verbal episodic memory (= 25 min.)
Day 1
|
day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 Copy of Rey's complex figure in order to assess episodic visual memory (Rey Osterrieth, 1941) (= 20 min)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 Verbal and visuo-spatial auditory empans (Wechsler scale Memory form III, 1997) to assess short-term memory and working memory (= 5 min)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 Copy of Rey's complex figure (Rey-Osterrieth, 1941) assessing visual-constructive abilities and planning (= 5 min)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 The Brixton Test, a spatial anticipation task that also evaluates executive functioning (Burgess P.W. & Shallice T. (1996) (= 15 min)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 Trail Making Test A and B (Reitan et al., 1950) assessing treatment speed and mental flexibility (= 5 min)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 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)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 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)
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 A BRIEF-A (Behavioural Evaluation Inventory of Executive Functions - Adult Version): 10min
|
Day 1
|
|
Neuropsychological abnormalities
Time Frame: 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 Research into recurrent symptoms such as headache (seniority, frequency), fatigability, sleep disturbance, dizziness, blurred vision, photo-phonophobia
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stéphane KREMER, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 9414
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.
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