NCT03653195|Completed
Diagnosis of Sport-related Concussion Using Urine Metabolites
Diagnosing Sport-related Concussion Using Urine Metabolomics: A 1H NMR-Based Analysis
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Diagnosing Sport-related Concussion Using Urine Metabolomics: A 1H NMR-Based Analysis
Sponsor study identifier
interventional
120
1 country
1
Study Start
August 1, 2010
Actual (reported)Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)Millions of sport related concussions (SRC) occur yearly in the United States, and current diagnosis of concussion is based upon largely subjective clinical evaluations. The objective of this study is to determine whether urinary metabolites are significantly altered post SRC. Urine of 26 athletes will be analyzed pre-injury and after SRC by 1H NMR spectroscopy. Data will be analyzed using multivariate statistics, pairwise t-test, and metabolic pathway analysis. Variable Importance Analysis based on random Variable Combination (VIAVC) was used to select what features are present out of 224 features. Partial least squares discriminant analysis was performed leading to separation between pre-season and post-SRC groups. A Receiver Operator Curve (ROC) curve will be constructed to classify the features. Pathway topology analysis will also be completed to determine biological pathways are potentially affected following SRC.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2010
Actual (reported)August 28, 2018
Actual (reported)August 31, 2018
Actual (reported)November 1, 2019
Actual (reported)November 1, 2019
Actual (reported)Urine metabolite profile
224 urine metabolites were analyzed pre- and post sport related concussion to determine which metabolites were altered post injury.
Samples were taken within 72 hours of injury
Each participant will act as their own control. Pre-injury samples were collected.
Post-injury samples were collected at the same time and within 72 hours of injury.
We aim to determine of a specific urine metabolomic biomarkers can diagnose concussion.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chantel T Debert
Calgary, Alberta, T2N2T9, Canada
Canadian Institute for Health Information. Head Injuries in Canada: A Decade of Change (1994-1995 to 2003-2004). Available at http://secure.cihi.ca/cihiweb/products/ntr_head_injuries_20 06_e.pdf
Lichtenstein JD, Moser RS, Schatz P. Age and test setting affect the prevalence of invalid baseline scores on neurocognitive tests. Am J Sports Med. 2014 Feb;42(2):479-84. doi: 10.1177/0363546513509225. Epub 2013 Nov 15.
Papa L, Ramia MM, Edwards D, Johnson BD, Slobounov SM. Systematic review of clinical studies examining biomarkers of brain injury in athletes after sports-related concussion. J Neurotrauma. 2015 May 15;32(10):661-73. doi: 10.1089/neu.2014.3655. Epub 2015 Jan 23.
Chantel T Debert, MD MSc
University of Calgary
120 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2018
First Posted
August 31, 2018
Study Start
August 1, 2010
Actual (reported)Omega-3 Treatment for Concussion in Adolescents
Contact the study team to confirm eligibility.
Lindon JC, Holmes E, Bollard ME, Stanley EG, Nicholson JK. Metabonomics technologies and their applications in physiological monitoring, drug safety assessment and disease diagnosis. Biomarkers. 2004 Jan-Feb;9(1):1-31. doi: 10.1080/13547500410001668379.
Nicholson JK, Lindon JC, Holmes E. 'Metabonomics': understanding the metabolic responses of living systems to pathophysiological stimuli via multivariate statistical analysis of biological NMR spectroscopic data. Xenobiotica. 1999 Nov;29(11):1181-9. doi: 10.1080/004982599238047. No abstract available.
Eriksson L, Johansson E, Kettaneh-Wold N, Trygg J, Wikström C, Wold S. Multi- and megavariate data analysis part I: basic principles and applications. Umeå, Sweden: Umetrics AB;2006. p. 425.
Dieterle F, Ross A, Schlotterbeck G, Senn H. Probabilistic quotient normalization as robust method to account for dilution of complex biological mixtures. Application in 1H NMR metabonomics. Anal Chem. 2006 Jul 1;78(13):4281-90. doi: 10.1021/ac051632c.
van Beek JD. matNMR: a flexible toolbox for processing, analyzing and visualizing magnetic resonance data in Matlab. J Magn Reson. 2007 Jul;187(1):19-26. doi: 10.1016/j.jmr.2007.03.017. Epub 2007 Apr 7.
Anderson, P.E.; Mahle, M.A.; Doom, T.E.; Reo, N.V.; DelRaso, N.J.; Raymer, M.L. Dynamic Adaptive binning: an improved quantification technique for NMR spectroscopic data. Metabolomics. 2011, 7, 179-190.
Craig A, Cloarec O, Holmes E, Nicholson JK, Lindon JC. Scaling and normalization effects in NMR spectroscopic metabonomic data sets. Anal Chem. 2006 Apr 1;78(7):2262-7. doi: 10.1021/ac0519312.
Daneshvar DH, Nowinski CJ, McKee AC, Cantu RC. The epidemiology of sport-related concussion. Clin Sports Med. 2011 Jan;30(1):1-17, vii. doi: 10.1016/j.csm.2010.08.006.
McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)Last Updated
September 30, 2021
Record last verified: 2020-05
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