Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Difference of connectivity maps between the players with concussion and the group control
研究概览
简要总结
This study assess the putative persistence of neural damage using resting state fMRI after concussion in rugby player once they have clinically recovered. The hypothesis is that despite a clinical recovery (absence of symptoms; neurological and neuropsychological examination returned to normal) connectivity map obtained using resting state fMRI are significantly different from a group of control subjects.
详细描述
Resting state fMRI has shown to be a sensitive tool to assess neural damage after concussion. It seems more sensible than structural MRI including DTI. the study goal will be to assess rugby players using fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3). The study would specifically like to challenge clinical examination supposed to be normal at V2 to connectivity maps using resting state fMRI preformed at the same time. fMRI performed at V1 and V3 will serve as comparators (respectively very altered at V1 and back to normal at V3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •no neurological or psychiatric disease
- •recent history of concussion (<3 months) according to the Rugby French Federation criteria.
排除标准
- •Inability to be assessed by MRI
研究组 & 干预措施
Concussion Group
Players with a recent (<72 hours) history of concussion will be assessed 3 times. just after concussion, after disappearance of clinical symptoms and 3 months after the previous visit. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.
干预措施: fMRI (Device)
Control Group
a control group with no history of concussion will be the comparator. Participants will be assessed 3 times. Visits will be the same for the control group and duration between visits in this group will be matched to the concussion group. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.
干预措施: fMRI (Device)
结局指标
主要结局
Difference of connectivity maps between the players with concussion and the group control
时间窗: up to 1 month
connectivity maps obtained during a 10 minutes resting state fMRI at V2
次要结局
- Difference of connectivity maps between the players with concussion and the group control(up to 3 months)
- neurophysiological data(up to 3 months)
- neuropsychological questionnaire(up to 3 months)