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| ID | Type | Description | Link |
|---|---|---|---|
| 24.05325.000379 | Other Identifier | Comité de protection des personnes (French Ethics committee) |
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| Name | Class |
|---|---|
| Centre National de la Recherche Scientifique, France | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the concentration of salivary BMs | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Specific Non-Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendpouiré A OUEDRAOGO, MSc | Contact | +33 (0) 467 047 481 | alimata.ouedraogo@sys2diag.cnrs.fr |
| Name | Affiliation | Role |
|---|---|---|
| Malik KAHLI, PhD | Sys2Diag | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sys2Diag - Umr9005 Cnrs/Alcen | Recruiting | Montpellier | 34184 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32387427 | Background | 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. | |
| 18417235 | 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. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Saliva
|
Measure the acceleration and deceleration forces experienced by players during these matches, as well as their number. |
| 3 Years |
| Compare the profiles of BMs | Compare the profiles of BMs in the saliva of professional sports players before and after each match. | 3 Years |
| 38867444 | 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. |
| 38460080 | 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. |
| 33135344 | 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. |
| 39104376 | 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. |
| 37938534 | 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. |
| 37340004 | 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. |
| 32881763 | 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. |
| 30601825 | 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. |
| 32595592 | 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. |
| 33757972 | 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. |
| 31977061 | 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |