CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
urine metabolomicsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03653195
NCT03653195N/ACompleted

Diagnosing Sport-related Concussion Using Urine Metabolomics: A 1H NMR-Based Analysis

University of Calgary·interventional·Posted Aug 31, 2018·Updated Sep 30, 2021

In Brief

A clinical study evaluating urine metabolomics for Concussion, Mild and Diagnoses, Syndromes, and Conditions. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 7.8 years ago

Interventions

urine metabolomicsother

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