Objective Concussion Assessment Using MRI and Metabolomics (NCT05993351) | Clinical Trial Compass
RecruitingNot Applicable
Objective Concussion Assessment Using MRI and Metabolomics
Canada100 participantsStarted 2023-08-11
Plain-language 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.
Who can participate
Age range
9 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 9-50
* Recently sustained a concussion (within the last 2 weeks)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional brain characteristics
Timeframe: 45-minute MRI sessions acutely, 3-months and 6-months post-concussion
2
Microstructural brain characteristics
Timeframe: 45-minute MRI sessions acutely, 3-months and 6-months post-concussion
3
Post-concussion symptoms
Timeframe: Acutely, 3-months and 6-months post-concussion