Pilot Study on the Correlation Between Accelerations Experienced
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.
Sys2Diag
66 participants
Jan 22, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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).
- Subject who has suffered a recent stroke or epileptic event (within the last two months)
- Subject suffering from neurological diseases.
Exclusion Criteria6
- 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.
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Interventions
Nucleic acids will be extracted from the participants' saliva using a commercial extraction kit (Qiagen). The miRNAs will then be analyzed by RT-qPCR. The miRNAs will first undergo a reverse transcription step to generate complementary DNAs. Then, using specific primers, the complementary DNAs will be amplified and measured by quantitative PCR (qPCR). The levels of proteins of interest (NSE, UCHL1, and GFAP) will be measured in the participants' saliva using enzymatic assay methods or ELISA-type methods carried out using commercial kits. An instrumented mouthguard will measure the intensity (acceleration) and the number of impacts sustained by each player during matches.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07507253