RecruitingPhase IIIInterventional

To test artificial intelligence (AI)-assisted magnetic resonance imaging (MRI) in detecting disease activity in Multiple Sclerosis, and to determine whether AI impacts MRI review, treatment decisions, costs, and follow-up care

This study is investigating a new computer program called icobrain ms that uses artificial intelligence (AI) to help doctors read MRI scans of the brain in people with Multiple Sclerosis (MS). MS is a condition affecting the brain and spinal cord, and regular MRI scans are important for monitoring its activity and how well treatments are working. The aim is to see if using icobrain ms alongside a doctor's review of the scans can more accurately detect signs of MS activity. Researchers also want to find out if this AI technology helps doctors make better treatment decisions, improves patient care, and offers good value for money within the NHS.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Queen Mary University of London

Enrolment target

1,336

Start

15 Apr 2025

Estimated completion

15 Dec 2026

Multiple sclerosis

What is this study about?

Multiple Sclerosis (MS) is a condition that affects your brain and spinal cord, which can lead to various symptoms and disabilities over time. To keep an eye on MS and how well treatments are working, regular brain scans, called MRIs, are usually part of your care. These scans help doctors see any changes or new signs of MS activity within your brain.

Reading these MRI scans can be a complex and time-consuming job for doctors, as they often look for very small changes. This study is testing a new computer program called icobrain ms. This program uses a type of technology called Artificial Intelligence (AI) to analyse MRI scans. It aims to help doctors by picking out important details and changes in the brain that might show MS activity. The goal is to see if this AI assistance makes it easier and quicker for doctors to spot disease activity and helps them decide if a change in your treatment might be needed.

The researchers want to understand if using icobrain ms makes a real difference in how MS is monitored and treated. They will be looking at whether it helps doctors detect MS activity more effectively, if it influences treatment choices, how it impacts your overall care, and even if it could make MRI reporting more efficient and cost-effective for the NHS. Your usual treatment plan will not change if you take part; all care will follow the standard procedures for MS patients.

Key takeaways

This study uses AI to help doctors interpret MS brain scans.
It aims to improve detection of MS activity and guide treatment decisions.
Participation involves no extra tests or changes to your current treatment.
The AI tool, icobrain ms, works alongside expert doctors, not instead of them.
Potential benefits include more accurate scan results and better patient care.
The study runs until April 2027 and is funded by the UK government.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and have either been diagnosed with Multiple Sclerosis (MS) or have had a 'Clinically Isolated Syndrome' (CIS), which is often an early sign of MS. You should also be having an MRI scan of your brain as part of your normal care plan and either be currently taking medication for MS or considering starting it.

This study will involve patients who are already receiving care for MS at one of the participating hospitals. Your doctor or another member of your care team would identify you as a potential participant if you meet the study requirements and are due for your routine MRI scan. You would also need access to a smartphone, tablet, or computer.

The main reason you couldn't take part is if you are already involved in another specific type of clinical trial for a new MS medication. The study can include people who might have some memory or thinking difficulties due to their MS, but importantly, everyone who takes part must be able to understand the study and agree to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of MS or Clinically Isolated Syndrome (CIS)?
Are you due for a routine brain MRI scan?
Are you currently taking MS medication or considering starting it?
Are you NOT in another clinical trial testing a new MS medicine?
Do you have access to a smartphone, tablet, or computer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need any extra hospital visits or assessments beyond what you'd normally have for your MS care. The study will bring together 1336 people from three different hospitals across the UK. Essentially, the trial is observing how doctors use the icobrain ms software during your routine MRI scan review, alongside their usual way of looking at your scans.

You won't be given any new medication as part of this study; your MS treatment will continue as normal. The total duration of the study itself runs from May 2022 to April 2027, but your individual involvement would align with your routine MRI scans and follow-up care that you would receive anyway.

Potential risks and benefits

There are no direct risks to you from using the icobrain ms software, as it's a tool to help doctors, not to make medical decisions on its own. Expert doctors will always be involved in interpreting your scans. Potential benefits from this research include more accurate and consistent reporting of your MRI scans, which could lead to earlier detection of MS activity and potentially help your doctor make more informed decisions about your treatment, ultimately aiming to improve your long-term health. The study also hopes to make MRI reporting more efficient and equally good for all patients across the NHS, regardless of where they are treated. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (6)

Barts Health NHS Trust
City only
London, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
City only
Nottingham, England
Torbay and South Devon NHS Foundation Trust
City only
Torquay, England
University Hospitals of Leicester NHS Trust
City only
Leicester, England
Kings College Hospital
Approximate
London, England

Common questions

What is AI and how is it used in this study?

AI stands for Artificial Intelligence. In this study, it's a computer program called icobrain ms that helps doctors look for signs of MS activity on your brain MRI scans. It processes the scan images to highlight important areas of change.

Will this study change my MS treatment?

No, your MS treatment will continue as usual, following your standard care plan. The icobrain ms software helps your doctor monitor your condition, but it doesn't change your existing treatment decisions.

Do I need to do anything extra if I join the study?

No, you don't need to do anything extra. Your involvement means that your routine MRI scans will be reviewed with the help of the icobrain ms software, in addition to your doctor's usual assessment.

What if I have memory problems from MS?

The study aims to include people with MS, even if they have some memory or thinking problems. However, you must still be able to understand what the study involves and agree to take part.

Who is paying for this study?

This study is being funded by the Department of Health and Social Care in the UK.

How to find out more

Klaus Schmierer

k.schmierer@qmul.ac.uk +44 20 7882 6246 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.