Pilot Study on the Correlation Between Accelerations Experienced (BIOIMPACT)

April 3, 2026 updated by: Malik KAHLI, Sys2Diag

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34184
        • Recruiting
        • Sys2Diag - Umr9005 Cnrs/Alcen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Malik KAHLI, PhD
        • Sub-Investigator:
          • Thi Nhu Ngoc VAN, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 66 subjects will be recruited from the players of the French under-20 rugby team (U20) called up for sporting events such as the Six Nations Tournament or the World Cup.

Their saliva will be analysed and the variations in biomarkers of interest will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
U20
The saliva of 66 professional rugby players from the French U20 team will be analysed and the variations in biomarkers of interest (identified as related to concussion) will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.
Diagnostic test: Analyze 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the intensity and number of impacts
Time Frame: 3 Years
The 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).
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the concentration of salivary BMs
Time Frame: 3 Years
Measure 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.
3 Years
Measure the acceleration and deceleration forces
Time Frame: 3 Years
Measure the acceleration and deceleration forces experienced by players during these matches, as well as their number.
3 Years
Compare the profiles of BMs
Time Frame: 3 Years
Compare the profiles of BMs in the saliva of professional sports players before and after each match.
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sys2Diag

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: Malik KAHLI, PhD, Sys2Diag

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

January 21, 2028

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02331-46
  • 24.05325.000379 (Other Identifier: Comité de protection des personnes (French Ethics committee))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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