Objective Concussion Assessment Using MRI and Metabolomics

NCT05993351 | Recruiting

• 1 other identifier: Concussion MRI & recovery
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

functional magnetic resonance imaging; diffusion tensor imaging; symptom tracking; sport-related concussions

Outcome Measures

Primary Outcomes (3)

• Functional brain characteristics

  Brain function will be examined based on the network connectivity and fractal complexity of the rsfMRI BOLD signal. This will be measured across known brain networks (e.g., Default Mode Network) and specific regions-of-interest (e.g., insula).

  45-minute MRI sessions acutely, 3-months and 6-months post-concussion

• Microstructural brain characteristics

  Microstructural brain changes will be examined based on diffusion tensor imaging (DTI) metrics of fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity. This will be measured within specific regions-of-interest (e.g., insula).

  45-minute MRI sessions acutely, 3-months and 6-months post-concussion

• Post-concussion symptoms

  Tracking of self-reported post-concussion symptoms using PCSS and DASS-42 questionnaires

  Acutely, 3-months and 6-months post-concussion

Secondary Outcomes (1)

• Metabolomics

  Acutely, 3-months and 6-months post-concussion

Study Arms (2)

Concussion

Individuals who have recently sustained a concussion within the past 2-weeks.

Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Urine and saliva samples; Behavioral: Questionnaires

Healthy Control

Individuals who have limited to no concussion history, and have not recently sustained a concussion.

Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Urine and saliva samples; Behavioral: Questionnaires

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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.

Concussion; Healthy Control

Urine and saliva samples DIAGNOSTIC_TEST

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.

Concussion; Healthy Control

Questionnaires BEHAVIORAL

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.

Concussion; Healthy Control

Eligibility Criteria

• Age: 9 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants for this prospective observational cohort will include 50 individuals who have recently sustained a concussion within the last 2 weeks. Participants will primarily be recruited based on their involvement in collision or contact sport, causing sport-related concussions. Fifty healthy control participants will be recruited with the intention to have age, sex and athletic status matching to the concussion participants.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

Imaging Research Center at St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (26)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and saliva samples will be collected during each study visit for all participants to perform the metabolomic analyses. These samples will be stored in a -80 degree Celcius freezer until the time of batch analysis, for which the samples will be consumed. Any remaining biospecimens not consumed in the analyses will be disposed of appropraitely.

MeSH Terms

Conditions

Brain Concussion

Interventions

Magnetic Resonance Imaging; Urination; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael D Noseworthy, PhD, PEng

  McMaster University

  PRINCIPAL INVESTIGATOR

• Dinesh A Kumbhare, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D Noseworthy, PhD, PEng

CONTACT

905.525.9140; nosewor@mcmaster.ca

Ethan Danielli, PhD

CONTACT

daniee4@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MRI Research, Imaging Research Centre

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 15, 2023
• Study Start: August 11, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 15, 2025

Record last verified: 2024-11

Locations

CA (1)