Objective Concussion Assessment Using MRI and Metabolomics
ConditionConcussion, Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-50
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Aged between 9-50
Recently sustained a concussion (within the last 2 weeks)
Disqualifiers
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
Pacemaker
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Magnetic resonance imaging (MRI)
Diagnostic testAll 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.
Urine and saliva samples
Diagnostic testAt 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.
Questionnaires
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Concussion3 interventions
Group B: Healthy Control3 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
45-minute MRI sessions acutely, 3-months and 6-months post-concussion2
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).
Time frame
45-minute MRI sessions acutely, 3-months and 6-months post-concussion3
Post-concussion symptoms
Tracking of self-reported post-concussion symptoms using PCSS and DASS-42 questionnaires
Time frame
Acutely, 3-months and 6-months post-concussionSecondary outcomes
1
Metabolomics
High throughput multi-segment injection-capillary electrophoresis-mass spectrometry technology will be used to analyze the urine and saliva samples to identify if any polar or non-polar metabolites are abnormal post-concussion, and that may indicate physiological markers for future assessment and treatment options.
Time frame
Acutely, 3-months and 6-months post-concussionSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Joseph's Healthcare Hamilton
Lead sponsor
McMaster University
Collaborator
Source ClinicalTrials.gov