Pilot Study on the Correlation Between Accelerations Experienced During Matches by Professional Rugby Players and a Profile of Salivary Biomarkers Identified in the Literature as Related to Concussion.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assess the intensity and number of impacts
研究概览
简要总结
Concussion, or mild traumatic brain injury, accounts for 85% of brain injuries and is common in both professional and amateur sports. It results from kinetic impacts causing a temporary disruption of brain function, often without visible abnormalities on imaging, making diagnosis difficult.
The majority of concussions remain undetected, without specific management. To facilitate detection, the development of reliable salivary BMs is essential, as they offer a non-invasive, rapid, and simple method for early identification of biological changes related to concussions.
详细描述
Concussion, or mild traumatic brain injury, accounts for 85% of brain injuries and is common in both professional and amateur sports. It results from kinetic impacts causing a temporary disruption of brain function, often without visible abnormalities on imaging, making diagnosis difficult.
The majority of concussions remain undetected, without specific management. Recently, several molecular biomarkers (BMs) of concussion in high-level athletes have been identified.
However, the physiological reference values of these BMs are not yet sufficiently established to allow optimal use of diagnostic tests for concussion. To facilitate detection, the development of reliable salivary BMs is essential, as they offer a non-invasive, rapid, and simple method for early identification of biological changes related to concussions.
It is also crucial to correlate these changes with the physical forces experienced by players during impacts. Indeed, the literature indicates that concussions can result from rapid head movements, often caused by violent linear and angular accelerations/decelerations, even if indirect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 20 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject
- •Subject aged between 19 and 20 years
- •Subject willing to follow the study procedures
- •Subject capable of understanding the purpose, nature, and methodology of the study
- •Subject affiliated with a French social security scheme or a beneficiary of such a scheme
- •Subject who has signed the non-opposition to participation in the research
- •Subject who has signed the informed consent for salivary micro-RNA analysis
- •Subject selected in the French under-20 rugby team (U20).
排除标准
- •Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme
- •Subject deprived of liberty, protected adults, vulnerable persons, or minors
- •Subject with proven or suspected chronic infectious disease that may pose a risk of contamination during sample handling (laboratories not equipped to handle this type of sample)
- •Subject suffering from Gougerot-Sjögren syndrome (dry syndrome)
- •Refusal to sign the non-opposition
- •Refusal to sign the informed consent for salivary micro-RNA analysis.
- •Specific Non-Inclusion Criteria:
- •Subject who has suffered a recent stroke or epileptic event (within the last two months)
- •Subject suffering from neurological diseases.
研究组 & 干预措施
U20
The saliva of 66 professional rugby players from the French U20 team will be analysed and the variations in biomarkers of interest (identified as related to concussion) will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.
干预措施: Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations. (Diagnostic Test)
结局指标
主要结局
Assess the intensity and number of impacts
时间窗: 3 Years
The primary objective is to assess whether the intensity and number of impacts (acceleration forces) sustained by players during high-intensity matches are correlated with a variation in the profiles of salivary biomarkers (proteins and short nucleic acids) described for concussion, which will be measured before and after a match in professional rugby players (U20).
次要结局
- Measure the concentration of salivary BMs(3 Years)
- Measure the acceleration and deceleration forces(3 Years)
- Compare the profiles of BMs(3 Years)
研究者
Malik KAHLI
Research Engeneer CNRS/Project Manager
Sys2Diag