The clinical motivation for the PROCLAIM study stems from the critical need for more sensitive and objective measures to monitor disease progression and treatment effectiveness in MS. Conventional clinical assessments can be subject to inter-rater variability and may not capture the subtle, continuous neurodegeneration that contributes to long-term disability, a phenomenon often described as Progression Independent of Relapse Activity (PIRA) (Lublin et al. 2022; Tur et al. 2023; Giovannoni et al. 2022; Scalfari et al. 2024). Furthermore, the integration of quantitative imaging biomarkers into routine clinical practice remains a challenge. Reliably quantifying structural brain changes from Magnetic Resonance Imaging (MRI) offers a potential solution to enhance therapeutic decision-making. Therefore, this prospective study is designed to gather real-world evidence on the clinical impact of such AI-assisted care.

The PROCLAIM study is conducted within the framework of the CLAIMS project (grant No 101112153). PROCLAIM is a prospective, multi-country, multi-site, single-blinded comparative effectiveness study. It is registered on clinicaltrials.gov under the identifier NCT07032246. The study’s primary objective is to compare the effectiveness of two care arms, with the intervention arm integrating AI software for quantitative brain MRI analysis (icobrain mr, providing the icobrain ms output) in the clinical routine. This AI software serves as the investigated medical device. The study is jointly sponsored by icometrix NV and Charité – Universitätsmedizin Berlin, who are responsible for its conduct on behalf of the CLAIMS consortium. The execution involves six principal investigator sites across the European Union (Charité – Universitätsmedizin Berlin, Technische Universität Dresden, Ruhr University Bochum, General University Hospital Prague, Casa di Cura Igea Milan, and ASST Papa Giovanni XXIII Bergamo).

Each study participant will be enrolled for a period of 24 months. Comprehensive data will be collected, including standard clinical assessments, biomarker measurements, as well as patient-reported outcomes collected via a mobile app (icompanion).

The study’s ultimate goal is to generate robust clinical evidence supporting the value of AI-assisted MS care for improved patient management and its feasibility in clinical routine.