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

NCT ID: NCT07032246

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-09
• Study Completion Date: 2028-11-30

Brief 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.

Detailed Description

PROCLAIM (Clinical Impact through AI-assisted MS care: a prospective multi-centre study) is a prospective multi-country multi-site comparative effectiveness study conducted within the scope of the EU-funded research project "Clinical impact through AI-assisted MS Care" (CLAIMS). Quantitative brain MRI will be implemented in this study based on the icobrain mr medical device. icobrain mr is an AI software solution for brain MRI analysis in multiple sclerosis that provides quantitative measurements on disease activity and progression. icobrain mr is CE-marked as a medical device software Class IIa and will be used in PROCLAIM according to its intended use. The study does not involve procedures additional to those performed under the normal conditions of use of the device, nor any other invasive or burdensome procedures.

The study will assess the impact of using quantitative brain MRI, as measured by icobrain mr, on the quality of care. In particular, the study will evaluate the impact on detecting disease activity in MS, as well as on clinical decision-making and clinical outcomes in routine clinical practice for people with MS (pwMS). The study will target both the inflammatory and smouldering components of the disease using assessments already used in daily clinical routine. Exploratory analyses will focus on the relation to other biomarkers used in clinical routine of the participating sites (optic coherence tomography (OCT), evoked potentials (EPs)), as well as patient reported outcomes and passive monitoring measurements (sleep duration, step count and environmental temperature) collected via the icompanion patient app, in conjunction with clinical and radiological parameters.

Conditions

Multiple Sclerosis; Radiologically Isolated Syndrome; Clinically Isolated Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Standard of Care

Standard of Care practices at each participating site will be employed. Participants in the control arm will receive care according to the usual procedures of the site, without icobrain mr analysis being provided to the participating site during the main study period.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

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

Standard of Care with quantitative brain MRI (icobrain mr)

Participants in the intervention arm will receive care according to the usual procedures of the participating sites and will have their brain MRI scans analysed using the icobrain mr software. icobrain mr results for each participant will be provided to the participating site prior to the regular clinic visit during the study period.

Group Type: EXPERIMENTAL

quantitative brain MRI (icobrain mr)

Intervention Type: DEVICE

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).

Standard of Care (SOC)

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DEVICE

Standard of Care (SOC)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

Casa di Cura IGEA

OTHER

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

icometrix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General University Hospital Prague

Prague, Prague, Czechia

Katholisches Klinikum Bochum - St. Joseph-Hospital

Bochum, North Rhine-Westphalia, Germany

Technische Universität Dresden

Dresden, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

ASST Papa Giovanni XXIII Bergamo

Bergamo, , Italy

Casa di Cura Igea

Milan, , Italy

Countries

Czechia; Germany; Italy

Related Links

https://www.claims.ms/

Website of the EU-funded CLAIMS project of which this study is a part.

Other Identifiers

ICO-S-003

Identifier Type: -

Identifier Source: org_study_id