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Objective Concussion Assessment Using MRI and Metabolomics

NCT05993351 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-05-15

No results posted yet for this study

Summary

Mild traumatic brain injury (mTBI), also referred to as concussions, affect millions of people around the world and can cause harmful long term effects. Unfortunately, concussions can be hard to diagnose and many people have lasting post-concussion symptoms such as headaches, difficulty concentrating, and light sensitivity. Recent studies have shown that advanced magnetic resonance imaging (MRI) techniques can identify subtle brain changes caused by a concussion. This study aims to track concussions over time measuring MRI brain scans and post-concussion symptoms to gain a better understand how the brain is affected in comparison to symptoms.

Conditions

  • Concussion, Brain

Interventions

DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI)

All participants will have 3 MRI scanning sessions to track brain health over time following the same protocol each time. The MRI sessions will occur acutely (\<2 weeks post-concussion), 3-months and 6-months post-concussion. A series of MRI scans will be acquired including T1, T2, T2-FLAIR, SWI, ASL, rsfMRI, and DTI scans to characterize structural, microstructural, functional and tissue perfusion changes within the brain over time.

DIAGNOSTIC_TEST

Urine and saliva samples

At each study visit all participants will be asked to provide small urine and saliva samples for a metabolomic analysis using a high throughput multi-segment injection-capillary electrophoresis-mass spectrometry technology. This will allow for rapid non-targeted analysis of polar/hydrophilic metabolites, as well as non-polar/ionic lipids with stringent quality control.

BEHAVIORAL

Questionnaires

The Post-Concussion Symptom Scale (PCSS) and the Depression Anxiety Stress Scale (DASS-42) will be used to assess the self-reported presence and severity of known concussion-related symptoms.

Sponsors & Collaborators

Principal Investigators

  • Michael D Noseworthy, PhD, PEng · McMaster University

  • Dinesh A Kumbhare, MD, PhD · University Health Network, Toronto

Eligibility

Min Age
9 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-11
Primary Completion
2026-12-15
Completion
2026-12-15

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT05993351 on ClinicalTrials.gov