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.

NCT Number	NCT07032246
Lead Sponsor	icometrix Collaborators: Ruhr University of Bochum, Technische Universität Dresden, Casa di Cura IGEA, General University Hospital, Prague, Charite University, Berlin, Germany
Conditions	Multiple Sclerosis, Radiologically Isolated Syndrome, Clinically Isolated Syndrome
Enrollment	750 participants
Start Date	2025-10-09
Primary Completion	2028-08-31 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-09