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Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05426980
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Ljubljana
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ziga Spiclin, PhD
Principal Investigator Affiliation	University of Ljubljana
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Slovenia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Multiple Sclerosis Lesion, Multiple Sclerosis Brain Lesion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.