Pilot Study on the Correlation Between Accelerations Experienced (NCT07507253) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study on the Correlation Between Accelerations Experienced
France66 participantsStarted 2025-01-22
Plain-language 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.
Who can participate
Age range19 Years – 20 Years
SexMALE
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Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.