Pilot Study on the Correlation Between Accelerations Experienced
ConditionSport Related Concussion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age19-20
SponsorSys2Diag
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
A total of 66 subjects will be recruited from the players of the French under-20 rugby team (U20) called up for sporting events such as the Six Nations Tournament or the World Cup. Their saliva will be analysed and the variations in biomarkers of interest will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.
Diagnostic testNucleic 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.
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: U201 intervention
Trial outcomes
Primary outcomes
1
Assess the intensity and number of impacts
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).
Time frame
3 YearsSecondary outcomes
1
Measure the concentration of salivary BMs
Measure the concentration of salivary BMs during competitive matches such as the Six Nations Tournament of the French under-20 rugby team (U20) to determine the physiological values of the biomarkers.
Time frame
3 Years2
Measure the acceleration and deceleration forces
Measure the acceleration and deceleration forces experienced by players during these matches, as well as their number.
Time frame
3 Years3
Compare the profiles of BMs
Compare the profiles of BMs in the saliva of professional sports players before and after each match.
Time frame
3 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sys2Diag
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Source ClinicalTrials.gov