[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":43,"locations":52,"responsibleParty":72,"collaborators":75,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Concussion",null,"Individuals who have recently sustained a concussion within the past 2-weeks.",[13,14,15],"Diagnostic Test: Magnetic resonance imaging (MRI)","Diagnostic Test: Urine and saliva samples","Behavioral: Questionnaires",{"label":17,"type":10,"description":18,"interventionNames":19},"Healthy Control","Individuals who have limited to no concussion history, and have not recently sustained a concussion.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"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 (\\\u003C2 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.",[9,17],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"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\u002Fhydrophilic metabolites, as well as non-polar\u002Fionic lipids with stringent quality control.",[9,17],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"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.",[9,17],[36,40],{"name":37,"affiliation":38,"role":39},"Michael D Noseworthy, PhD, PEng","McMaster University","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Dinesh A Kumbhare, MD, PhD","University Health Network, Toronto",[44,49],{"name":37,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","905.525.9140","23727","nosewor@mcmaster.ca",{"name":50,"role":45,"phone":10,"phoneExt":10,"email":51},"Ethan Danielli, PhD","daniee4@mcmaster.ca",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Imaging Research Center at St. Joseph's Healthcare Hamilton","RECRUITING","Hamilton","Ontario","L8N 4A6","Canada","CA",{"type":62,"coordinates":63},"Point",[64,65],-79.84963,43.25011,{"lat":65,"lon":64},[68,70],{"name":37,"role":45,"phone":69,"phoneExt":10,"email":48},"(905) 522-1155",{"name":50,"role":45,"phone":10,"phoneExt":10,"email":71},"ethan.danielli@uhn.ca",{"type":39,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Michael Noseworthy PhD","Director of MRI Research, Imaging Research Centre",[76],{"name":38,"class":6},"100515580","objective-concussion-assessment-using-mri-and-metabolomics-100515580",false,"NCT05993351","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)","Inclusion Criteria:\n\n* Aged between 9-50\n* Recently sustained a concussion (within the last 2 weeks)\n\nExclusion Criteria:\n\n* Aged 8 and younger or 51 and older\n* Unable to provide consent (e.g., poor English language skills, etc.)\n* History of liver or kidney disease\n* MRI contraindications:\n\n  * Pacemaker\n  * Stent\n  * Joint prothesis\n  * Implanted devices\n  * Claustrophobia\n  * Pregnant\n  * Permanent piercings\n* Chronic\u002Fabusive use of alcohol and\u002For illicit drugs\n* Previous stroke or moderate\u002Fsevere traumatic brain injury, subarachnoid hemorrhage, or intracranial hemorrhage\n* Healthy control participants must not have a concussion history or recently sustained a concussion",true,"ALL","9 Years","50 Years",{"count":89,"type":90},100,"ESTIMATED","OBSERVATIONAL","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.",[94],"Concussion, Brain",[96,97,98,99],"functional magnetic resonance imaging","diffusion tensor imaging","symptom tracking","sport-related concussions","2025-05-12",{"date":102,"type":103},"2025-05-15","ACTUAL",{"date":105,"type":103},"2023-08-11",{"date":107,"type":90},"2026-12-15",{"name":5,"class":6},1]