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Salivary Biomarkers for Concussion

NCT06149351 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Sport Related Concussion

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.

Sponsors & Collaborators

  • Centre National de la Recherche Scientifique, France

    collaborator OTHER

  • Sys2Diag

    lead OTHER_GOV

Principal Investigators

  • Thi Nhu Ngoc VAN, Phd · Sys2Diag

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-06-12
Completion
2027-12-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149351 on ClinicalTrials.gov