Pilot Study on the Correlation Between Accelerations Experienced
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Sys2Diag - Umr9005 Cnrs/Alcen | Montpellier | France | Recruiting |
More Sys2Diag trials in France
Other trials for the same condition
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