Linking head accelerations to saliva concussion markers in French U20 rugby players
Official title: 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.
Run by Sys2Diag · NCT07507253 · Data updated 2026-11-12
We will try to see if saliva micro-RNAs and other biomarkers change after head impacts recorded by instrumented mouthguards in male French under-20 rugby players.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years to 20 Years |
| Sex | Men only |
| Enrollment | 66 (estimated) |
| Sponsor | Sys2Diag Government |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | January 22, 2025 |
| Main results expected | January 21, 2027 |
| Study ends | January 21, 2028 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07507253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male athletes aged 19–20 who are members of the French under-20 rugby team, able to give informed consent, and affiliated with the French social security system.
✕Probably not a fit
People outside the enrolled demographic (women, other ages, non-rugby players), those without French social security coverage, or those with exclusions such as chronic infectious disease or Sjögren’s syndrome are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational pilot enrolling male players aged 19–20 from the French under-20 rugby team who wear instrumented mouthguards during play to record linear and rotational head accelerations. Investigators will collect serial saliva samples to measure micro-RNAs and other candidate biomarkers and will compare biomarker changes with the mouthguard acceleration data. The goal is to define physiological reference values in this population and determine whether specific acceleration patterns are linked to measurable salivary changes. The protocol excludes participants with certain chronic infections or Sjögren’s syndrome and requires French social security affiliation.
Why it matters
Potential benefit: If successful, the work could lead to a rapid, noninvasive saliva test tied to recorded head impacts to help identify concussions earlier in young rugby players.
How similar studies have gone: Previous work in high-level athletes has identified candidate concussion biomarkers, but reference ranges and direct correlations with instrumented impact measures—especially using salivary micro-RNAs—remain incompletely established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Sys2Diag - Umr9005 Cnrs/Alcen
Montpellier, France Recruiting
Study contacts
- Principal investigator: Malik KAHLI, PhD — Sys2Diag
- Study coordinator: Wendpouiré A OUEDRAOGO, MSc
- Email: alimata.ouedraogo@sys2diag.cnrs.fr
- Phone: +33 (0) 467 047 481
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Saliva biomarkers to help detect sport-related concussion
This project will test whether saliva biomarkers can help detect sport-related concussion in men aged 18 to 50.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.