Sys2Diag - Umr9005 Cnrs/Alcen
Montpellier, 34184, France
Location status: Recruiting
Location contact
Franck MOLINA, PhD
CONTACT
Malik KAHLI, PhD
PRINCIPAL_INVESTIGATOR
Thi Nhu Ngoc VAN, PhD
SUB_INVESTIGATOR
Wendpouiré A OUEDRAOGO, MSc
CONTACT
NCT Number: NCT07507253
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.
Interested in participating?
Request Info19 year–20 year
Male
Observational
Montpellier, 34184, France
Location status: Recruiting
Franck MOLINA, PhD
CONTACT
Malik KAHLI, PhD
PRINCIPAL_INVESTIGATOR
Thi Nhu Ngoc VAN, PhD
SUB_INVESTIGATOR
Wendpouiré A OUEDRAOGO, MSc
CONTACT
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. Recently, several molecular biomarkers (BMs) of concussion in high-level athletes have been identified.
However, the physiological reference values of these BMs are not yet sufficiently established to allow optimal use of diagnostic tests for concussion. 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.
It is also crucial to correlate these changes with the physical forces experienced by players during impacts. Indeed, the literature indicates that concussions can result from rapid head movements, often caused by violent linear and angular accelerations/decelerations, even if indirect.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific Non-Inclusion Criteria:
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.
Time frame: 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).
Time frame: 3 Years
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 Years
Measure the acceleration and deceleration forces experienced by players during these matches, as well as their number.
Time frame: 3 Years
Compare the profiles of BMs in the saliva of professional sports players before and after each match.
Contact information is provided by the study sponsor or research team.
Sys2Diag
Other Gov
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.
Acronym: BIOIMPACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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