NCT03653195

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 30, 2021

Status Verified

May 1, 2020

Enrollment Period

9.3 years

First QC Date

August 28, 2018

Last Update Submit

September 28, 2021

Conditions

Concussion, MildDiagnoses, Syndromes, and Conditions

Keywords

concussionbiomarkermetabolomicurineNMR spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pre-injury

OTHER

Each participant will act as their own control. Pre-injury samples were collected.

Other: urine metabolomics

Post-injury

ACTIVE COMPARATOR

Post-injury samples were collected at the same time and within 72 hours of injury.

Other: urine metabolomics

Interventions

urine metabolomicsOTHER

We aim to determine of a specific urine metabolomic biomarkers can diagnose concussion.

Post-injuryPre-injury

Eligibility Criteria

Age15 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than 18 years
  • diagnosis of concussion determined by the specialists (sports medicine physician or physiatrist)
  • concussion sustained within 72 hours of being seen.

You may not qualify if:

  • multiple injuries sustained coinciding with the concussive head injury
  • past medical history of neurological pathology such as seizures, CNS tumors or neurodegenerative disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chantel T Debert

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (12)

  • 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

    BACKGROUND

  • 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.

    PMID: 24243771BACKGROUND

  • 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.

    PMID: 25254425BACKGROUND

  • 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.

    PMID: 15204308BACKGROUND

  • 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.

    PMID: 10598751BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16808434BACKGROUND

  • 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.

    PMID: 17448713BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16579606BACKGROUND

  • 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.

    PMID: 21074078RESULT

  • 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.

    PMID: 23479479RESULT

MeSH Terms

Conditions

Brain ConcussionDisease

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chantel T Debert, MD MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

August 1, 2010

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 30, 2021

Record last verified: 2020-05

Locations

CA(1)