NCT07032246Enrolling by invitation
Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 9 Oct 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- icometrix
- Diseases
- Multiple sclerosis
- NCT number
- NCT07032246
What you commit to
- Study type: Interventional
- Planned participants: 750
- From 9 Oct 2025 to the primary completion date, 31 Aug 2028
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study.
Other
- 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.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General University Hospital Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Katholisches Klinikum Bochum - St. Joseph-Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| ASST Papa Giovanni XXIII Bergamo Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Casa di Cura Igea Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.