[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631943":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sys2Diag","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"U20",null,"The saliva of 66 professional rugby players from the French U20 team will be analysed and the variations in biomarkers of interest (identified as related to concussion) 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.",[13],"Diagnostic Test: Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","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).\n\nThe 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.\n\nAn instrumented mouthguard will measure the intensity (acceleration) and the number of impacts sustained by each player during matches.",[9],[21],{"name":22,"affiliation":5,"role":23},"Malik KAHLI, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Wendpouiré A OUEDRAOGO, MSc","CONTACT","+33 (0) 467 047 481","alimata.ouedraogo@sys2diag.cnrs.fr",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Sys2Diag - Umr9005 Cnrs\u002FAlcen","RECRUITING","Montpellier","34184","France","FR",{"type":39,"coordinates":40},"Point",[41,42],3.87635,43.61093,{"lat":42,"lon":41},[45,49,50,51],{"name":46,"role":27,"phone":47,"phoneExt":10,"email":48},"Franck MOLINA, PhD","+33 (0) 467 047 460","s2d.cpp@sys2diag.cnrs.fr",{"name":26,"role":27,"phone":28,"phoneExt":10,"email":48},{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Thi Nhu Ngoc VAN, PhD","SUB_INVESTIGATOR",{"type":23,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Malik KAHLI","Research Engeneer CNRS\u002FProject Manager",[58],{"name":59,"class":60},"Centre National de la Recherche Scientifique, France","OTHER","100631943","pilot-study-on-the-correlation-between-accelerations-experienced-100631943",false,"NCT07507253","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.","BIOIMPACT","Inclusion Criteria:\n\n* Male subject\n* Subject aged between 19 and 20 years\n* Subject willing to follow the study procedures\n* Subject capable of understanding the purpose, nature, and methodology of the study\n* Subject affiliated with a French social security scheme or a beneficiary of such a scheme\n* Subject who has signed the non-opposition to participation in the research\n* Subject who has signed the informed consent for salivary micro-RNA analysis\n* Subject selected in the French under-20 rugby team (U20).\n\nExclusion Criteria:\n\n* Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme\n* Subject deprived of liberty, protected adults, vulnerable persons, or minors\n* 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)\n* Subject suffering from Gougerot-Sjögren syndrome (dry syndrome)\n* Refusal to sign the non-opposition\n* Refusal to sign the informed consent for salivary micro-RNA analysis.\n\nSpecific Non-Inclusion Criteria:\n\n* Subject who has suffered a recent stroke or epileptic event (within the last two months)\n* Subject suffering from neurological diseases.",true,"MALE","19 Years","20 Years",{"count":74,"type":75},66,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[79],"Sport Related Concussion",[81,82,83,84],"Concussion","Biomarkers","Sport","Instrumented mouthguards","2026-04-03",{"date":87,"type":88},"2026-04-09","ACTUAL",{"date":90,"type":88},"2025-01-22",{"date":92,"type":75},"2028-01-21",{"name":5,"class":6},1]