RecruitingNCT07507253

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.


Sponsor

Sys2Diag

Enrollment

66 participants

Start Date

Jan 22, 2025

Study Type

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

Sex: MALEMin Age: 19 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations. for people with sport-related concussion. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAnalyze 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.


Locations(1)

Sys2Diag - Umr9005 Cnrs/Alcen

Montpellier, France

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NCT07507253


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