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Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study

Enrolling By InvitationNA

Sponsor: icometrix

Conditions: Multiple Sclerosis, Radiologically Isolated Syndrome, Clinically Isolated Syndrome

Interventions: quantitative brain MRI (icobrain mr), Standard of Care (SOC)

Countries: Czechia, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (6)

Prague, Prague, Czechia
Bochum, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Berlin, State of Berlin, Germany
Bergamo, Italy
Milan, Italy