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

NCT07032246 | Enrolling By Invitation

• 1 other identifier: ICO-S-003
• Study Type: interventional
• Target: 750
• Locations: 3 countries
• Sites: 6

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.

Conditions

Multiple Sclerosis; Radiologically Isolated Syndrome; Clinically Isolated Syndrome

Keywords

Multiple Sclerosis; Quantitative Brain MRI; icobrain mr; Neurodegeneration; Disease activity; Disease worsening

Outcome Measures

Primary Outcomes (2)

• Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity

  The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.

  baseline

• Impact of using icobrain mr on the clinical outcome

  The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.

  month 24

Secondary Outcomes (18)

• Proportion of patients who switch treatment

  baseline

• Objective of each treatment switch

  baseline

• Role of disease activity on MRI in the decision to make a treatment switch

  baseline

• Role of quantitative brain MRI in the decision to make a treatment switch

  baseline

• Neurologist confidence in the clinical decision-making process (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)

  baseline

Other Outcomes (12)

• Correlation of spinal cord C2/C3-level atrophy with measurements of clinical disease worsening

  baseline, month 12, month 24

• Correlation of paramagnetic rim lesion load with measurements of clinical disease worsening

  baseline, month 12, month 24

• Correlation of OCT-derived parameters with measurements of clinical disease worsening

  month 24

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care (SOC)

Standard of Care with quantitative brain MRI (icobrain mr)

EXPERIMENTAL

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.

Device: quantitative brain MRI (icobrain mr); Other: Standard of Care (SOC)

Interventions

Standard of Care (SOC) OTHER

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

Standard of Care; Standard of Care with quantitative brain MRI (icobrain mr)

quantitative brain MRI (icobrain mr) 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 with quantitative brain MRI (icobrain mr)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• icometrix: lead
• Ruhr University of Bochum: collaborator
• Technische Universität Dresden: collaborator
• Casa di Cura IGEA: collaborator
• General University Hospital, Prague: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (6)

General University Hospital Prague

Prague, Prague, 2 128 00, Czechia

Location

Katholisches Klinikum Bochum - St. Joseph-Hospital

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Technische Universität Dresden

Dresden, Saxony, 01062, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 131256, Germany

Location

ASST Papa Giovanni XXIII Bergamo

Bergamo, Italy

Location

Casa di Cura Igea

Milan, Italy

Location

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis; Nerve Degeneration

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 22, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); IT (2); CZ (1)