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

Artificial intelligence-assisted magnetic resonance imaging for quality, efficiency and equity in the NHS care of multiple sclerosis - phase III: real world testing of icobrain ms

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99207647

Enrollment

1336

Registered

2025-02-28

Start date

2025-04-15

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases

Interventions

We will conduct a prospective clinical study to compare icobrain ms-assisted MRI to the current Standard of Care (SoC) in assessing disease activity. The Interventional arm is defined by ‘radiological

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. 18 years of age and above 2. Clinically Isolated Syndrome suggestive of demyelination (CIS) or definitive diagnosis of MS 3. Undergoing MRI head investigation 4. On an MS DMT pathway 5. Access to a smartphone, tablet or computer

Exclusion criteria

Exclusion criteria: People with MS (pwMS) participating in a randomised controlled Clinical Trial of an investigational medicinal product (CTIMP) (pwMS participating in a single arm study may be included, provided this is acceptable with the CTIMP protocol)

Design outcomes

Primary

Measure	Time frame
The proportion of patients have disease activity detected when icobrain ms is being employed, alongside the visual assessment, compared to SoC assessment by a (neuro)radiologist.	—

Secondary

Measure	Time frame
1. Brain volume loss based on baseline-year 1 and/or, where available, retrospective-baseline 2. Treatment initiation or switch decisions based on baseline-year 1 and/or, where available, retrospective-baseline 3. Number of relapse(s) measured using patient records from baseline to year 1 4. Clinical deterioration, stability or improvement measured using patient records based on baseline-year 1 5. Mean time (minutes/seconds) to produce a radiologist-authorised MRI brain report measured using patient records 6. Incremental cost per quality-adjusted life year (QALY) gained with use of icobrain ms measured using EQ-5D-5L and Resource Use questionnaires at baseline, 6 months and 12 months post-enrolment. The Resource Use Questionnaire is a purpose developed questionnaire asking participants to report their use of inpatient, outpatient and community healthcare, social care, help with personal care and out-of-pocket costs.	—

Measure

Time frame

1. Brain volume loss based on baseline-year 1 and/or, where available, retrospective-baseline 2. Treatment initiation or switch decisions based on baseline-year 1 and/or, where available, retrospective-baseline 3. Number of relapse(s) measured using patient records from baseline to year 1 4. Clinical deterioration, stability or improvement measured using patient records based on baseline-year 1 5. Mean time (minutes/seconds) to produce a radiologist-authorised MRI brain report measured using patient records 6. Incremental cost per quality-adjusted life year (QALY) gained with use of icobrain ms measured using EQ-5D-5L and Resource Use questionnaires at baseline, 6 months and 12 months post-enrolment. The Resource Use Questionnaire is a purpose developed questionnaire asking participants to report their use of inpatient, outpatient and community healthcare, social care, help with personal care and out-of-pocket costs.

—

Countries

England, United Kingdom

Contacts

Public ContactKlaus Schmierer

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026