Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06149351

Salivary Biomarkers for Concussion

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluate the baseline level of salivary molecular 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.

  2. Evaluate the baseline level of salivary molecular biomarkers

    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.

Secondary outcomes

  1. Differential analysis of expression signatures of salivary sncRNAs of the three groups

    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.

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

    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.

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

    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.

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

    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.

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

    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.

  6. Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendpouiré A OUEDRAOGO, Msc

CONTACT

[email protected]

+33 (0) 467 047 481

Sponsors and collaborators

Lead sponsor

Sys2Diag

Other Gov

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study title

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

Acronym: SportCo

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 29, 2023
Registry last updated
Mar 16, 2026

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.

Published trials that share one or more normalized conditions with this study.