RecruitingNCT05993351

Objective Concussion Assessment Using MRI and Metabolomics

Correlating Advanced MRI Techniques With Neuropsychological Analysis and Immunosensing Assays for Assessment of Sport-related Mild Traumatic Brain Injuries (mTBI)


Sponsor

St. Joseph's Healthcare Hamilton

Enrollment

100 participants

Start Date

Aug 11, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 9 YearsMax Age: 50 Years

Inclusion Criteria2

  • Aged between 9-50
  • Recently sustained a concussion (within the last 2 weeks)

Exclusion Criteria14

  • Aged 8 and younger or 51 and older
  • Unable to provide consent (e.g., poor English language skills, etc.)
  • History of liver or kidney disease
  • MRI contraindications:
  • Pacemaker
  • Stent
  • Joint prothesis
  • Implanted devices
  • Claustrophobia
  • Pregnant
  • Permanent piercings
  • Chronic/abusive use of alcohol and/or illicit drugs
  • Previous stroke or moderate/severe traumatic brain injury, subarachnoid hemorrhage, or intracranial hemorrhage
  • Healthy control participants must not have a concussion history or recently sustained a concussion

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Interventions

DIAGNOSTIC_TESTMagnetic 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_TESTUrine 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.

BEHAVIORALQuestionnaires

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.


Locations(1)

Imaging Research Center at St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

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