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

Summary

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.

Conditions

• Multiple Sclerosis
• Radiologically Isolated Syndrome
• Clinically Isolated Syndrome

Interventions

DEVICE

quantitative brain MRI (icobrain mr)

Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan. The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI).

OTHER

Standard of Care (SOC)

Standard of Care practices at each participating site for management of multiple sclerosis.

Sponsors & Collaborators

• Ruhr University of Bochum

  collaborator OTHER

• Technische Universität Dresden

  collaborator OTHER

• Casa di Cura IGEA

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• icometrix

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-09

Primary Completion

2028-08-31

Completion

2028-11-30

Countries

• Czechia
• Germany
• Italy

Study Locations