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Recruiting Observational

Pilot Study on the Correlation Between Accelerations Experienced

NCT07507253 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Observational
Started
2025-01-22
Last updated
2026-04-09

Condition(s) studied

Sport Related Concussion

Investigational drug(s) / intervention(s)

Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.

Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.: 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.

Study 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

Sex
MALE
Min age
19 Years
Max age
20 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Assess the intensity and number of impacts — 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).

Trial sites (1)

FacilityCityRegionStatus
Sys2Diag - Umr9005 Cnrs/Alcen Montpellier France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07507253 on ClinicalTrials.gov ↗ ← All trials in France