Sys2Diag - Umr9005 Cnrs/Alcen
Montpellier, 34184, France
Location status: Recruiting
Location contact
Franck MOLINA, Phd
CONTACT
Malik KAHLI, Phd
SUB_INVESTIGATOR
Thi Nhu Ngoc VAN, Phd
PRINCIPAL_INVESTIGATOR
Wendpouiré A OUEDRAOGO, Msc
CONTACT
NCT Number: NCT06149351
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.
Interested in participating?
Request Info18 year–50 year
Male
Observational
Montpellier, 34184, France
Location status: Recruiting
Franck MOLINA, Phd
CONTACT
Malik KAHLI, Phd
SUB_INVESTIGATOR
Thi Nhu Ngoc VAN, Phd
PRINCIPAL_INVESTIGATOR
Wendpouiré A OUEDRAOGO, Msc
CONTACT
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. It is essentially based on subjective observational criteria and on the determination of the Glasgow Coma Scale (GCS) score, a score of 13 to 15 indicating potential CC. In approximately 15% of cases, symptoms such as momentary loss of consciousness (less than 30 minutes), amnesia lasting less than 24 hours, neurological deficit, or convulsions can be used to make a diagnosis. In the majority of cases, concussion goes undetected and no specific treatment or rehabilitation is put in place.
Recently, certain molecular biomarkers (BMs) of CC in elite athletes have been identified (Di Pietro et al. 2021; McCrea et al. 2020). However, the reference values of these BMs are not determined with sufficient robustness to enable the best use for concussion diagnostic tests.
To detect these biomarkers, it is first necessary to determine their physiological profiles as well as the changes in intensity associated with intense physical efforts during training session and/or matches.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Non-inclusion specific criteria
Saliva 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.
Time frame: 3 years
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 years
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 years
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 years
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 years
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 years
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 years
Comparison of expression signatures of salivary sncRNAs at the beginning, in the middle and by the end of the sports season.
Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Time frame: 3 years
Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins at the beginning, in the middle and by the end of the sports season.
Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Contact information is provided by the study sponsor or research team.
Sys2Diag
Other Gov
Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
Acronym: SportCo
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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