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Diagnosis of Sport-related Concussion Using Urine Metabolites

NCT03653195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-30

No results posted yet for this study

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.

Conditions

  • Concussion, Mild
  • Diagnoses, Syndromes, and Conditions

Interventions

OTHER

urine metabolomics

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

Sponsors & Collaborators

  • University of Lethbridge

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Chantel T Debert, MD MSc · University of Calgary

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653195 on ClinicalTrials.gov