Tests a brain MRI software tool in people with multiple sclerosis
Compares standard care with added quantitative brain MRI to detect disease activity in multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
Key facts
- Where
- Prague, CzechiaSee the site
Where in Czechia
- General University Hospital PraguePrague, CzechiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- icometrix
- Trial code
- NCT07032246
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
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.
Inclusion: 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: Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study; 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; 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.