Pilot Study on the Correlation Between Accelerations Experienced

NCT07507253 | Recruiting

• 2 other identifiers: 2024-A02331-4624.05325.000379
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sport Related Concussion

Keywords

Concussion; Biomarkers; Sport; Instrumented mouthguards

Outcome Measures

Primary Outcomes (1)

• Assess the intensity and number of impacts

  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 Outcomes (3)

• Measure the concentration of salivary BMs

  3 Years

• Measure the acceleration and deceleration forces

  3 Years

• Compare the profiles of BMs

  3 Years

Study Arms (1)

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.

Interventions

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.

U20

Eligibility Criteria

• Age: 19 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Subject who has suffered a recent stroke or epileptic event (within the last two months)
• Subject suffering from neurological diseases.

Sponsors & Collaborators

• Sys2Diag: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Sys2Diag - Umr9005 Cnrs/Alcen

Montpellier, 34184, France

RECRUITING

Related Publications (13)

• Lefevre-Dognin C, Cogne M, Perdrieau V, Granger A, Heslot C, Azouvi P. Definition and epidemiology of mild traumatic brain injury. Neurochirurgie. 2021 May;67(3):218-221. doi: 10.1016/j.neuchi.2020.02.002. Epub 2020 May 6.

  PMID: 32387427 BACKGROUND

• van Stegeren AH, Wolf OT, Kindt M. Salivary alpha amylase and cortisol responses to different stress tasks: impact of sex. Int J Psychophysiol. 2008 Jul;69(1):33-40. doi: 10.1016/j.ijpsycho.2008.02.008. Epub 2008 Mar 5.

  PMID: 18417235 BACKGROUND

• Roe G, Sawczuk T, Owen C, Tooby J, Starling L, Gilthorpe MS, Falvey E, Hendricks S, Rasmussen K, Readhead C, Salmon D, Stokes K, Tucker R, Jones B. Head Acceleration Events During Tackle, Ball-Carry, and Ruck Events in Professional Southern Hemisphere Men's Rugby Union Matches: A Study Using Instrumented Mouthguards. Scand J Med Sci Sports. 2024 Jun;34(6):e14676. doi: 10.1111/sms.14676.

  PMID: 38867444 BACKGROUND

• Tooby J, Till K, Gardner A, Stokes K, Tierney G, Weaving D, Rowson S, Ghajari M, Emery C, Bussey MD, Jones B. When to Pull the Trigger: Conceptual Considerations for Approximating Head Acceleration Events Using Instrumented Mouthguards. Sports Med. 2024 Jun;54(6):1361-1369. doi: 10.1007/s40279-024-02012-5. Epub 2024 Mar 9.

  PMID: 38460080 BACKGROUND

• Hicks SD, Onks C, Kim RY, Zhen KJ, Loeffert J, Loeffert AC, Olympia RP, Fedorchak G, DeVita S, Rangnekar A, Leddy J, Haider MN, Gagnon Z, McLoughlin CD, Badia M, Randall J, Madeira M, Yengo-Kahn AM, Wenzel J, Heller M, Zwibel H, Roberts A, Johnson S, Monteith C, Dretsch MN, Campbell TR, Mannix R, Neville C, Middleton F. Diagnosing mild traumatic brain injury using saliva RNA compared to cognitive and balance testing. Clin Transl Med. 2020 Oct;10(6):e197. doi: 10.1002/ctm2.197.

  PMID: 33135344 BACKGROUND

• Woodward J, Tooby J, Tucker R, Falvey EC, Salmon DM, Starling L, Tierney G. Instrumented mouthguards in elite-level men's and women's rugby union: characterising tackle-based head acceleration events. BMJ Open Sport Exerc Med. 2024 Aug 1;10(3):e002013. doi: 10.1136/bmjsem-2024-002013. eCollection 2024.

  PMID: 39104376 BACKGROUND

• Tooby J, Woodward J, Tucker R, Jones B, Falvey E, Salmon D, Bussey MD, Starling L, Tierney G. Correction to: Instrumented Mouthguards in Elite-Level Men's and Women's Rugby Union: The Incidence and Propensity of Head Acceleration Events in Matches. Sports Med. 2024 May;54(5):1339-1341. doi: 10.1007/s40279-023-01968-0. No abstract available.

  PMID: 37938534 BACKGROUND

• Daneshvar DH, Nair ES, Baucom ZH, Rasch A, Abdolmohammadi B, Uretsky M, Saltiel N, Shah A, Jarnagin J, Baugh CM, Martin BM, Palmisano JN, Cherry JD, Alvarez VE, Huber BR, Weuve J, Nowinski CJ, Cantu RC, Zafonte RD, Dwyer B, Crary JF, Goldstein LE, Kowall NW, Katz DI, Stern RA, Tripodis Y, Stein TD, McClean MD, Alosco ML, McKee AC, Mez J. Leveraging football accelerometer data to quantify associations between repetitive head impacts and chronic traumatic encephalopathy in males. Nat Commun. 2023 Jun 20;14(1):3470. doi: 10.1038/s41467-023-39183-0.

  PMID: 37340004 BACKGROUND

• Powell JR, Boltz AJ, DeCicco JP, Chandran A, DeLellis SM, Healy ML, Kane SF, Lynch JH, Means GE, Hackney AC, Mihalik JP. Neuroinflammatory Biomarkers Associated With Mild Traumatic Brain Injury History in Special Operations Forces Combat Soldiers. J Head Trauma Rehabil. 2020 Sep/Oct;35(5):300-307. doi: 10.1097/HTR.0000000000000598.

  PMID: 32881763 BACKGROUND

• LaRocca D, Barns S, Hicks SD, Brindle A, Williams J, Uhlig R, Johnson P, Neville C, Middleton FA. Comparison of serum and saliva miRNAs for identification and characterization of mTBI in adult mixed martial arts fighters. PLoS One. 2019 Jan 2;14(1):e0207785. doi: 10.1371/journal.pone.0207785. eCollection 2019.

  PMID: 30601825 BACKGROUND

• Janigro D, Kawata K, Silverman E, Marchi N, Diaz-Arrastia R. Is Salivary S100B a Biomarker of Traumatic Brain Injury? A Pilot Study. Front Neurol. 2020 Jun 12;11:528. doi: 10.3389/fneur.2020.00528. eCollection 2020.

  PMID: 32595592 BACKGROUND

• Di Pietro V, O'Halloran P, Watson CN, Begum G, Acharjee A, Yakoub KM, Bentley C, Davies DJ, Iliceto P, Candilera G, Menon DK, Cross MJ, Stokes KA, Kemp SP, Belli A. Unique diagnostic signatures of concussion in the saliva of male athletes: the Study of Concussion in Rugby Union through MicroRNAs (SCRUM). Br J Sports Med. 2021 Dec;55(24):1395-1404. doi: 10.1136/bjsports-2020-103274. Epub 2021 Mar 23.

  PMID: 33757972 BACKGROUND

• McCrea M, Broglio SP, McAllister TW, Gill J, Giza CC, Huber DL, Harezlak J, Cameron KL, Houston MN, McGinty G, Jackson JC, Guskiewicz K, Mihalik J, Brooks MA, Duma S, Rowson S, Nelson LD, Pasquina P, Meier TB; CARE Consortium Investigators; Foroud T, Katz BP, Saykin AJ, Campbell DE, Svoboda SJ, Goldman J, DiFiori J. Association of Blood Biomarkers With Acute Sport-Related Concussion in Collegiate Athletes: Findings From the NCAA and Department of Defense CARE Consortium. JAMA Netw Open. 2020 Jan 3;3(1):e1919771. doi: 10.1001/jamanetworkopen.2019.19771.

  PMID: 31977061 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Malik KAHLI, PhD

  Sys2Diag

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendpouiré A OUEDRAOGO, MSc

CONTACT

+33 (0) 467 047 481; alimata.ouedraogo@sys2diag.cnrs.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Engeneer CNRS/Project Manager

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: January 22, 2025
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

FR (1)