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NCT Number: NCT07507253

Pilot Study on the Correlation Between Accelerations Experienced

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.

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Key information

Age range

19 year–20 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendpouiré A OUEDRAOGO, MSc

CONTACT

[email protected]

+33 (0) 467 047 481

Sponsors and collaborators

Lead sponsor

Sys2Diag

Other Gov

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study 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.

Acronym: BIOIMPACT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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