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Salivary Biomarkers for Concussion

Recruitingn/aAges 18 Years - 50 YearsMaleSys2Diag
NCT06149351 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult. Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male participants aged between 18 and 50 years old. * Participants willing to comply with the study procedures. * Participants capable of understanding the purpose, nature, and methodology of the study. * Participants affiliated to a French social security system or beneficiaries of such a system. * Participants who have signed the non-opposition form to participate in the research. Non-inclusion Criteria: * Participant not affiliated to a French social security system or not a beneficiary of such a system. * Participants deprived of liberty, protected adults, vulnerable individuals, or minors. * Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample). * Refusal to sign the non-opposition form to participate in the research. Non-inclusion specific criteria * Subject who has had a recent stroke or epilepsy event (within the past two months). * Subject suffering from neurological diseases.
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What it tests

  • Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
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Where

1 site
Sys2Diag - Umr9005 Cnrs/Alcen
Montpellier, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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