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Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study

NCT ID: NCT05426980

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

654 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis Multiple Sclerosis Lesion Multiple Sclerosis Brain Lesion

Keywords

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Artificial intelligence Prediction model Magnetic resonance imaging Computer-assisted image analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

General and Teaching Hospital Celje

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role collaborator

University Medical Centre Maribor

OTHER

Sponsor Role collaborator

Izola General Hospital

OTHER

Sponsor Role collaborator

University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Ziga Spiclin

Associate professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziga Spiclin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana

Locations

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University medical center Ljubljana

Ljubljana, Osrednjeslovenska, Slovenia

Site Status

General and teaching hospital Celje

Celje, , Slovenia

Site Status

General hospital Izola

Izola, , Slovenia

Site Status

University medical center Maribor

Maribor, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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0120-570/2021/5

Identifier Type: -

Identifier Source: org_study_id