NCT07111637

Brief Summary

Multiple Sclerosis (MS) is a long-term disease that affects over 150,000 people in the UK. Starting treatment early is important for managing Multiple Sclerosis (MS). It is also essential to monitor the treatment to see if it is working and to switch treatments if needed. Magnetic resonance imaging (MRI) is the only accepted tool to monitor how well the treatment is working. Current evaluation of brain Magnetic resonance imaging (MRI) scans requires visual inspection, of which sensitivity is degraded by human, and technical factors, such as lack of time, fatigue of radiologists, and lack of standardization of image acquisition protocols across the National Health Service (NHS). MRI-readings can be significantly enhanced by artificial intelligence (AI)-assistive software. Evidence suggests the rate of new lesion detection to be 3 - 4 times higher when using assistive software compared to visual inspection of MRI scans. In this study, an Artificial Intelligence (AI) software called "icobrain ms." developed by the company "icometrix" (Leuven, Belgium) is tested. This tool helps track MS by measuring changes in the brain using MRI scans. The AI can highlight problem areas and create reports that doctors can use to make better decisions about participants' treatment. The aim of the study is to prove that icobrain ms can be used to assist the neuro-radiologist with their visual assessment of MRI scans by a radiologist, and that it will help clinicians make more informed decisions about participants' current MS treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,336

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 1, 2025

Last Update Submit

August 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the clinical usefulness of icobrain ms by evaluating the detection of disease activity (as defined by new/expanding lesions).

    From enrollment to the end of treatment at 12 months

Study Arms (2)

Radiological reading by a neuroradiologist assisted by icobrain ms.

EXPERIMENTAL

icobrain ms Artificial Intelligence (AI) assistive software

Device: AI software

Radiological reading by a neuroradiologist

NO INTERVENTION

Standard of Care

Interventions

icobrain ms is an Artificial Intelligence (AI)-assistive software which quantifies brain Magnetic Resonance Imaging (MRIs) and summarises clinically relevant findings for patients with Multiple Sclerosis in structured electronic radiological reports and annotated images.

Radiological reading by a neuroradiologist assisted by icobrain ms.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically Isolated Syndrome suggestive of demyelination (CIS) or definitive diagnosis of MS.
  • Undergoing MRI head investigation.
  • On an MS DMT pathway.
  • Access to a smartphone, tablet or computer.

You may not qualify if:

  • patients with Multiples Sclerosis participating in a randomised controlled CTIMP (participating in a single arm study may be included, provided this is in line with the other protocol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, E1 4NS, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

June 14, 2025

Primary Completion

April 14, 2026

Study Completion

April 14, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations