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RECRUITING
NCT06149351

Salivary Biomarkers for Concussion

Sponsor: Sys2Diag

View on ClinicalTrials.gov

Summary

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.

Official title: Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2023-12-12

Completion Date

2027-12-12

Last Updated

2026-03-16

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion

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.

Locations (1)

Sys2Diag - Umr9005 Cnrs/Alcen

Montpellier, France