NCT07032246

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: icometrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-09
• Primary completion: 2028-08-31
• Completion: 2028-11-30
• First posted: 2025-06-22
• Last updated: 2025-12-09

Locations

6 sites across 3 countries: Czechia, Germany, Italy