Salivary Biomarkers for Concussion (SportCo)

Sys2Diag

Status: Enrolling

Conditions: Sport Related Concussion

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06149351

2023-A00188-37

23.00930.000169 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Sub-group S-P

Other group

Description:

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

Treatment:

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

Sub-group S-L

Other group

Description:

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

Treatment:

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

Sub-group S-O

Other group

Description:

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

Treatment:

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