Clinical Impact Through AI-assisted MS Care - A Prospective Multi-cent
Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
What it found
No result yet.
What was tested
Treatment tested
- quantitative brain MRI (icobrain mr)
Given to everyone in the trial
- Standard of Care (SOC)
What it measured
Main measures
Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity
baseline
Impact of using icobrain mr on the clinical outcome
month 24
Other measures (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
MRI lesionsRole of quantitative brain MRI in the decision to make a treatment switch
baseline
MRI lesionsNeurologist 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
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)
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)
baseline
Proportion of patients with detected smouldering or inflammatory disease components
baseline
Reported MRI findings at baseline
baseline
MRI lesionsBrain volume lossSmouldering inflammationProportion of patients with relapse associated worsening (RAW)
month 12 - month 24
Relapses
Who could take part
Relapsing and progressive · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Oct 2025
Main results due
Aug 2028
Finished
Nov 2028