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
Multiple sclerosis
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 reading by a neuro-radiologist assisted by icobrain ms. The SoC arm is defined by ‘radiological reading by a neuro-radiologist’. When describing SoC, the aim of the trial is not to provide a proscribed list of how a neuro-radiologist should read an MRI for this study, but to allow them to operate as they normally would. The total duration of the intervention and follow-up for all study arms is 1 year. Participants will attend a clinic and MRI visit as per their standard of care where they will be screened for the study and if eligible and happy to take part in, they will be consented and randomised into the study. Randomisation will be performed by an authorised member of the research team at the site using a web-based randomisation service. In addition to this, participants will complete two questionnaires on their health-related quality of life and resource use. Both arms will be followed-up at 6 and 12 months after enrolment into the study. At 6 months, participants will complete two questionnaires on their health-related quality of life and resource use. At 12 months, participants will have a clinic and MRI visit as per their standard of care and complete two questionnaires on their health-related quality of life and resource use.
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
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)