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Diagnosis of Sport-related Concussion Using Urine Metabolites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653195
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
University of Lethbridge
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease Intervention/treatment Phase
Concussion, Mild Diagnoses, Syndromes, and Conditions Other: urine metabolomics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosing Sport-related Concussion Using Urine Metabolomics: A 1H NMR-Based Analysis
Actual Study Start Date : August 1, 2010
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pre-injury
Each participant will act as their own control. Pre-injury samples were collected.
Other: urine metabolomics
We aim to determine of a specific urine metabolomic biomarkers can diagnose concussion.

Active Comparator: Post-injury
Post-injury samples were collected at the same time and within 72 hours of injury.
Other: urine metabolomics
We aim to determine of a specific urine metabolomic biomarkers can diagnose concussion.




Primary Outcome Measures :
  1. Urine metabolite profile [ Time Frame: Samples were taken within 72 hours of injury ]
    224 urine metabolites were analyzed pre- and post sport related concussion to determine which metabolites were altered post injury.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653195


Locations
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Canada, Alberta
Chantel T Debert
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
University of Calgary
University of Lethbridge
Investigators
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Principal Investigator: Chantel T Debert, MD MSc University of Calgary

Publications of Results:
Other Publications:
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
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.
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.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03653195    
Other Study ID Numbers: 23963
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If other researchers request the data we will share.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
concussion
biomarker
metabolomic
urine
NMR spectroscopy
Additional relevant MeSH terms:
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Brain Concussion
Disease
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
Pathologic Processes