Salivary Biomarkers for Concussion

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Evaluate the baseline level of salivary molecular biomarkers — 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.
• Evaluate the baseline level of salivary molecular biomarkers — 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.

Trial sites (1)

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