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AI brain scans could revolutionize MS care

NCT ID NCT07032246

Knowledge-focused Sponsor: icometrix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using an AI tool to analyze brain MRIs helps doctors spot signs of multiple sclerosis (MS) activity more accurately. About 750 people with MS or early warning signs will be split into two groups: one where doctors use the AI tool, and one where they rely on standard MRI reports. The goal is to see if AI leads to better treatment decisions and fewer MS flare-ups over two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Nerve Degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinically isolated syndrome Multiple sclerosis Radiologically isolated syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, Italy

  • Casa di Cura Igea

    Milan, Italy

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 131256, Germany

  • General University Hospital Prague

    Prague, Prague, 2 128 00, Czechia

  • Katholisches Klinikum Bochum - St. Joseph-Hospital

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Technische Universität Dresden

    Dresden, Saxony, 01062, Germany

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