Salivary Biomarkers for Concussion
ConditionSport Related Concussion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-50
SponsorSys2Diag
About this trial
Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult.
Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male participants aged between 18 and 50 years old.
Participants willing to comply with the study procedures.
Participants capable of understanding the purpose, nature, and methodology of the study.
Participants affiliated to a French social security system or beneficiaries of such a system.
Disqualifiers
None
Trial population
A total of 80 subjects will be recruited: * 30 professional sport subject, playing in the professional team of the Montpellier HandBall club (MHB) or the Montpellier Hérault Rugby (MHR) - BRAS S-P. * 30 leisure sport subjects with moderate physical activity playing in the leisure team of clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) or even to the clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) - BRAS S-L. * 20 occasional sport subjects with low intensity physical activity and whose weekly sports practice is less than 4 hours, excluding contact sports, recruited at Sys2diag, delegation 13 of CNRS or in sports clubs linked to the study - BRAS S-O.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
Diagnostic testSaliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Sub-group S-P1 intervention
Group B: Sub-group S-L1 intervention
Group C: Sub-group S-O1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the baseline level of salivary molecular biomarkers
Quantification of salivary small non coding RNA (sncRNA) biomarkers of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Time frame
3 years2
Evaluate the baseline level of salivary molecular biomarkers
Quantification of salivary biomarkers including ubiquitin c-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) proteins of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Time frame
3 yearsSecondary outcomes
1
Differential analysis of expression signatures of salivary sncRNAs of the three groups
Comparison of expression signatures of salivary sncRNAs among the professional athletes, amateur athletes, and occasional sport practitioners. Expression level of acid nucleic biomarkers are measured in copies/µL and fold change.
Time frame
3 years2
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups
Comparison of expression signatures of salivary UCH-L1, GFAP, NSE proteins among the professional athletes, amateur athletes, and occasional sport practitioners. Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Time frame
3 years3
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations
Comparison of expression signatures of salivary sncRNAs before, during and after different training sessions (bodybuilding, contact, etc) and matches. Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Time frame
3 years4
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations
Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins before, during and after different training sessions (bodybuilding, contact, etc) and matches.
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