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

Launched by ICOMETRIX · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial, called PROCLAIM, is looking at how using a special type of brain scan analysis—called quantitative brain MRI with the icobrain mr software—can help doctors better detect disease activity in people with multiple sclerosis (MS) and related conditions. The study aims to see if this advanced MRI tool can identify subtle ongoing disease changes that might be missed otherwise and how this information might improve treatment decisions and overall health outcomes for patients in everyday medical care.

People who may be eligible for this study include adults diagnosed with certain types of MS or early signs of MS, such as Radiologically Isolated Syndrome (RIS) or Clinically Isolated Syndrome (CIS). Participants need to be able to understand and agree to the study rules and have access to a smartphone or similar device to use an app related to the study. The study will compare two groups: one receiving standard care plus the advanced MRI analysis, and the other receiving standard care without it. If you join, you can expect to have regular brain MRI scans and clinical visits, with your care team using the MRI results to guide treatment. The trial is not recruiting yet and excludes people who can’t undergo MRI scans or who have other specific health conditions.

Gender

ALL

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.