Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study

Condition(s) studied

Investigational drug(s) / intervention(s)

quantitative brain MRI (icobrain mr): Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan. The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI).

Standard of Care (SOC): Standard of Care practices at each participating site for management of multiple sclerosis.

Study summary

The goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a real-world setting.

The study will compare an intervention arm implementing quantitative brain MRI (using the CE-marked medical device software icobrain mr) as part of Standard of Care, and a control arm implementing Standard of Care without quantitative brain MRI.

Eligibility

Primary outcome measure(s)

• Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity — baseline
  The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.
• Impact of using icobrain mr on the clinical outcome — month 24
  The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.

Trial sites (6)

Other trials for the same condition