Skip to content

Pilot Study on the Correlation Between Accelerations Experienced

Pilot Study on the Correlation Between Accelerations Experienced During Matches by Professional Rugby Players and a Profile of Salivary Biomarkers Identified in the Literature as Related to Concussion.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07507253
Acronym
BIOIMPACT
Enrollment
66
Registered
2026-04-02
Start date
2025-01-22
Completion date
2028-01-21
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sport Related Concussion

Keywords

Concussion, Biomarkers, Sport, Instrumented mouthguards

Brief summary

Concussion, or mild traumatic brain injury, accounts for 85% of brain injuries and is common in both professional and amateur sports. It results from kinetic impacts causing a temporary disruption of brain function, often without visible abnormalities on imaging, making diagnosis difficult. The majority of concussions remain undetected, without specific management. To facilitate detection, the development of reliable salivary BMs is essential, as they offer a non-invasive, rapid, and simple method for early identification of biological changes related to concussions.

Detailed description

Concussion, or mild traumatic brain injury, accounts for 85% of brain injuries and is common in both professional and amateur sports. It results from kinetic impacts causing a temporary disruption of brain function, often without visible abnormalities on imaging, making diagnosis difficult. The majority of concussions remain undetected, without specific management. Recently, several molecular biomarkers (BMs) of concussion in high-level athletes have been identified. However, the physiological reference values of these BMs are not yet sufficiently established to allow optimal use of diagnostic tests for concussion. To facilitate detection, the development of reliable salivary BMs is essential, as they offer a non-invasive, rapid, and simple method for early identification of biological changes related to concussions. It is also crucial to correlate these changes with the physical forces experienced by players during impacts. Indeed, the literature indicates that concussions can result from rapid head movements, often caused by violent linear and angular accelerations/decelerations, even if indirect.

Interventions

DIAGNOSTIC_TESTAnalyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.

Nucleic acids will be extracted from the participants' saliva using a commercial extraction kit (Qiagen). The miRNAs will then be analyzed by RT-qPCR. The miRNAs will first undergo a reverse transcription step to generate complementary DNAs. Then, using specific primers, the complementary DNAs will be amplified and measured by quantitative PCR (qPCR). The levels of proteins of interest (NSE, UCHL1, and GFAP) will be measured in the participants' saliva using enzymatic assay methods or ELISA-type methods carried out using commercial kits. An instrumented mouthguard will measure the intensity (acceleration) and the number of impacts sustained by each player during matches.

Sponsors

Sys2Diag
Lead SponsorOTHER_GOV
Centre National de la Recherche Scientifique, France
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
19 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* Male subject * Subject aged between 19 and 20 years * Subject willing to follow the study procedures * Subject capable of understanding the purpose, nature, and methodology of the study * Subject affiliated with a French social security scheme or a beneficiary of such a scheme * Subject who has signed the non-opposition to participation in the research * Subject who has signed the informed consent for salivary micro-RNA analysis * Subject selected in the French under-20 rugby team (U20).

Exclusion criteria

* Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme * Subject deprived of liberty, protected adults, vulnerable persons, or minors * Subject with proven or suspected chronic infectious disease that may pose a risk of contamination during sample handling (laboratories not equipped to handle this type of sample) * Subject suffering from Gougerot-Sjögren syndrome (dry syndrome) * Refusal to sign the non-opposition * Refusal to sign the informed consent for salivary micro-RNA analysis. Specific Non-Inclusion Criteria: * Subject who has suffered a recent stroke or epileptic event (within the last two months) * Subject suffering from neurological diseases.

Design outcomes

Primary

MeasureTime frameDescription
Assess the intensity and number of impacts3 YearsThe primary objective is to assess whether the intensity and number of impacts (acceleration forces) sustained by players during high-intensity matches are correlated with a variation in the profiles of salivary biomarkers (proteins and short nucleic acids) described for concussion, which will be measured before and after a match in professional rugby players (U20).

Secondary

MeasureTime frameDescription
Measure the concentration of salivary BMs3 YearsMeasure the concentration of salivary BMs during competitive matches such as the Six Nations Tournament of the French under-20 rugby team (U20) to determine the physiological values of the biomarkers.
Measure the acceleration and deceleration forces3 YearsMeasure the acceleration and deceleration forces experienced by players during these matches, as well as their number.
Compare the profiles of BMs3 YearsCompare the profiles of BMs in the saliva of professional sports players before and after each match.

Countries

France

Contacts

CONTACTWendpouiré A OUEDRAOGO, MSc
alimata.ouedraogo@sys2diag.cnrs.fr+33 (0) 467 047 481
PRINCIPAL_INVESTIGATORMalik KAHLI, PhD

Sys2Diag

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026