Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study (AI ProMiS)

November 28, 2023 updated by: Ziga Spiclin, University of Ljubljana
The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or, alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms. At the same time, the MS is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the CNS, which can be observed and quantified in the magnetic resonance (MR) scans. The proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

654

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Celje, Slovenia, 3000
        • General and Teaching Hospital Celje
      • Izola, Slovenia
        • General Hospital Izola
      • Maribor, Slovenia, 2000
        • University medical center Maribor
    • Osrednjeslovenska
      • Ljubljana, Osrednjeslovenska, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will be based on a retrospective secondary analysis of demographic and clinical data and MRI scans of approximately 1200 Slovenian patients with MS that are regularly monitored between 2015 and present.

Description

Inclusion Criteria:

  • persons diagnosed with MS (any phenotype; according to the 2010 McDonald criteria) and CIS patients
  • availability of at least two MRI exams with both FLAIR and T1-weighted scans of the same participant over a period of at least 6 months at the most recent examination
  • availability of demographic, clinical data and treatment information for the same participant over a period of at least 6 months at the most recent examination
  • availability of EDSS score and at least one previous EDSS scores for the same participant over a period of at least 6 months at the most recent examination

Exclusion Criteria:

  • other clinically relevant systemic diseases if the researcher considers them to be significant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrophied lesion volume derived from MRI predicts confirmed EDSS disability progression
Time Frame: Atrophied lesion volume quantified from two or more MR scans across the span of at least one and up to five years
Patients will be divided into two groups based on the presence or absence of EDSS disability progression (DP) during the observation period. The DP converters will be classified as patients with an EDSS change of at least 1.5 if the baseline EDSS is less than 1.0, those with an EDSS change of at least 1.0 if the baseline EDSS is 1.0-5.5, and those with an EDSS change of at least 0.5 if the baseline EDSS is 5.5 or higher [15]. DP converters should have confirmed progression of EDSS impairment over a period of at least 6 months. DP non-converters include individuals who do not meet the criteria for conversion. Atrophied lesion volume will be quantified from MR scans taken >6 months prior to the observed EDSS increase. Advanced artificial intelligence based image analysis tools will be applied to assess the atrophied lesion volume.
Atrophied lesion volume quantified from two or more MR scans across the span of at least one and up to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrophied lesion volume derived from MRI predicts conversion to secondary progressive multiple sclerosis
Time Frame: Atrophied lesion volume quantified from two or more MR scans across the span of least one and up to five years
Patients will be divided into two groups, i.e. those who transitioned from clinically isolate syndrome (CIS) or relapsing-remitting (RR) to secondary progressive (SP) form of MS and those who were diagnosed with CIS/RRMS during the observation period. A consilium for patients with MS will confirm the SPMS diagnosis by consensus. Atrophied lesion volume will be quantified from MR scans taken >6 months prior to the observed conversion to the SPMS. Advanced artificial intelligence based image analysis tools will be applied to assess the atrophied lesion volume.
Atrophied lesion volume quantified from two or more MR scans across the span of least one and up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana

Collaborators

Novartis
Izola General Hospital
University Medical Centre Ljubljana
General and Teaching Hospital Celje
University Medical Centre Maribor

Investigators

  • Principal Investigator: Ziga Spiclin, PhD, University of Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-570/2021/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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