Salivary Biomarkers for Concussion

Not Applicable

Not yet recruiting

• Conditions: Sport Related Concussion
• Interventions: Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion

• Registration Number: NCT06149351
• Lead Sponsor: Sys2Diag

Brief Summary

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. Toward a proper interpretation of the signal for a reliable diagnostic test, we aim to evaluate the physiological variations as well as the effect of different intensive trainings on the profile of these salivary biomarkers in professional athletes. Data generated form such analysis will help establish a baseline profile for these biomarkers whose change in intensity associated with concussion could be diagnosed in the future.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Study Start: 2023-11-28
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-09-28
• Study Completion: 2026-09-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Male participants aged between 18 and 40 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.
• Participants who have signed the non-opposition form to participate in the research.

Non-inclusion Criteria:

• Participant not affiliated to a French social security system or not a beneficiary of such a system.
• Participants deprived of liberty, protected adults, vulnerable individuals, or minors.
• Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample).
• Refusal to sign the non-opposition form to participate in the research.

Non-inclusion specific criteria

• Subject who has had a recent stroke or epilepsy event (within the past two months).
• Subject suffering from neurological diseases.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub-group S-L	Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion	20 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport.
Sub-group S-O	Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion	20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports.
Sub-group S-P	Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion	20 professional athletes whose weekly sport practice is more than 8 hours of contact sport.

Primary Outcome Measures

Name	Time	Method
Evaluate the baseline level of salivary molecular biomarkers	2 years	Quantification of salivary biomarkers including ubiquitin c-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) proteins; short nucleic acids or small non coding RNA (sncRNA) of all study subjects: before, during and after intense or moderate sports practice (training and/or matches).

Secondary Outcome Measures

Name	Time	Method
Differential analysis of expression signatures of salivary sncRNAs of the three groups	2 years	Comparison of expression signatures of salivary sncRNAs among the professional athletes, amateur athletes, and occasional sport practitioners.
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations	2 years	Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins before, during and after different training sessions (bodybuilding, contact, etc) and matches.
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season	2 years	Comparison of expression signatures of salivary sncRNAs at the beginning, in the middle and by the end of the sports season.
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups	2 years	Comparison of expression signatures of salivary UCH-L1, GFAP, NSE proteins among the professional athletes, amateur athletes, and occasional sport practitioners.
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations	2 years	Comparison of expression signatures of salivary sncRNAs before, during and after different training sessions (bodybuilding, contact, etc) and matches.
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season	2 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.