Cerebral and Cognitive Modifications in Retired Female Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportswomen : Transverse Analytic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cerebral MRI Microstructural abnormalities
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Female professional Soccer players
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).
干预措施: Cerebral MRI (Other)
Female athletes not exposed to head injuries.
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).
干预措施: Cerebral MRI (Other)
结局指标
主要结局
Cerebral MRI Microstructural abnormalities
时间窗: 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).
次要结局
未报告次要终点