quantitative brain MRI (icobrain mr)Standard of Care (SOC)
quantitative brain MRI (icobrain mr): Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan.
The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI).
Standard of Care (SOC): Standard of Care practices at each participating site for management of multiple sclerosis.
Study summary
The goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a real-world setting.
The study will compare an intervention arm implementing quantitative brain MRI (using the CE-marked medical device software icobrain mr) as part of Standard of Care, and a control arm implementing Standard of Care without quantitative brain MRI.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Able to independently understand, evaluate and sign the informed consent form.
* Able to comply with the study protocol, including having a mobile device capable of running the icompanion app.
* Have a definite diagnosis of MS, confirmed as per revised McDonald 2017 criteria (treated or untreated) and/or a diagnosis of RIS/CIS (following the revised McDonald criteria presented during ECTRIMS 2024)
* Patients early in the disease course of RRMS (CIS/RIS, RRMS with disease duration \< 7 years), patients with initial diagnosis of relapsing MS and disease duration 12-18 years (prone to convert to SPMS).
* Clinical and brain MRI data available at least one year prior to the study
* Age \>= 18 years
Exclusion Criteria:
* Unable or unwilling to understand, evaluate and sign the informed consent form.
* Any contraindications for undergoing an MRI.
* Currently involved in another interventional study.
* Currently pregnant or planning a pregnancy in the coming 2 years.
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study.
* Retrospective MRI not meeting requirements: at least, 3D T1-weighted images and fluid-attenuated inversion recovery (FLAIR) images (3D, or 2D with maximal slice thickness of 3mm).
* Patients with confirmed diagnosis of PPMS.
Primary outcome measure(s)
Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity — baseline The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.
Impact of using icobrain mr on the clinical outcome — month 24 The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.
Trial sites (6)
Facility
City
Region
Status
General University Hospital Prague
Prague
Prague
Katholisches Klinikum Bochum - St. Joseph-Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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