Salivary Biomarkers for Concussion

NCT06149351 | Recruiting

• 1 other identifier: 2023-A00188-37
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Concussion, Biomarkers, Sport

Outcome Measures

Primary Outcomes (2)

• 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.

  3 years

• 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.

  3 years

Secondary Outcomes (6)

• Differential analysis of expression signatures of salivary sncRNAs of the three groups

  3 years

• Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups

  3 years

• Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations

  3 years

• Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations

  3 years

• Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season

  3 years

Study Arms (3)

Sub-group S-P

30 professional athletes whose weekly sport practice is more than 8 hours of contact sport.

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

Sub-group S-L

30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport.

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

Sub-group S-O

20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports.

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

Interventions

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

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.

Sub-group S-L; Sub-group S-O; Sub-group S-P

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Participants who have signed the non-opposition form to participate in the research.
• 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.
• Subject who has had a recent stroke or epilepsy event (within the past two months).
• Subject suffering from neurological diseases.

Sponsors & Collaborators

• Sys2Diag: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Sys2Diag - Umr9005 Cnrs/Alcen

Montpellier, 34184, France

RECRUITING

Related Publications (2)

• Di Pietro V, Ragusa M, Davies D, Su Z, Hazeldine J, Lazzarino G, Hill LJ, Crombie N, Foster M, Purrello M, Logan A, Belli A. MicroRNAs as Novel Biomarkers for the Diagnosis and Prognosis of Mild and Severe Traumatic Brain Injury. J Neurotrauma. 2017 Jun 1;34(11):1948-1956. doi: 10.1089/neu.2016.4857. Epub 2017 Apr 10.

  PMID: 28279125 BACKGROUND

• Di Pietro V, O'Halloran P, Watson CN, Begum G, Acharjee A, Yakoub KM, Bentley C, Davies DJ, Iliceto P, Candilera G, Menon DK, Cross MJ, Stokes KA, Kemp SP, Belli A. Unique diagnostic signatures of concussion in the saliva of male athletes: the Study of Concussion in Rugby Union through MicroRNAs (SCRUM). Br J Sports Med. 2021 Dec;55(24):1395-1404. doi: 10.1136/bjsports-2020-103274. Epub 2021 Mar 23.

  PMID: 33757972 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Thi Nhu Ngoc VAN, Phd

  Sys2Diag

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendpouiré A OUEDRAOGO, Msc

CONTACT

+33 (0) 467 047 481; alimata.ouedraogo@sys2diag.cnrs.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher/Project Manager

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 29, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)