Menu
Enrolling by invitation NCT07032246

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

No phase Interventional Multiple Sclerosis Radiologically Isolated Syndrome Clinically Isolated Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: quantitative brain MRI (icobrain mr), Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Radiologically Isolated Syndrome, Clinically Isolated Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia, Germany, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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
  • Other Standard of Care (SOC)
    Standard of Care practices at each participating site for management of multiple sclerosis.

Primary outcome measures

  • Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity [Time frame: baseline]
  • Impact of using icobrain mr on the clinical outcome [Time frame: month 24]
Secondary outcome measures (12)
  • Proportion of patients who switch treatment [Time frame: baseline]
  • Objective of each treatment switch [Time frame: baseline]
  • Role of disease activity on MRI in the decision to make a treatment switch [Time frame: baseline]
  • Role of quantitative brain MRI in the decision to make a treatment switch [Time frame: 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) [Time frame: baseline]
  • Neurologist confidence in confirming the diagnosis of MS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident) [Time frame: baseline]
  • Neurologist confidence in confirming the conversion to SPMS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident) [Time frame: baseline]
  • Proportion of patients with detected smouldering or inflammatory disease components [Time frame: baseline]
  • Reported MRI findings at baseline [Time frame: baseline]
  • Proportion of patients with relapse associated worsening (RAW) [Time frame: month 12 - month 24]
  • Proportion of patients with smouldering associated worsening (SAW) [Time frame: month 12 - month 24]
  • Proportion of relapse-free participants between month 12 and month 24 [Time frame: month 12 - month 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Germany · 3 centers
  • Katholisches Klinikum Bochum - St. Joseph-Hospital — Bochum
  • Technische Universität Dresden — Dresden
  • Charité - Universitätsmedizin Berlin — Berlin
Italy · 2 centers
  • ASST Papa Giovanni XXIII Bergamo — Bergamo
  • Casa di Cura Igea — Milan
Czechia · 1 center
  • General University Hospital Prague — Prague

Identifiers

NCT: NCT07032246 · ICO-S-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗