Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
NCT ID: NCT05949580
Last Updated: 2026-01-20
Study Results
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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RECRUITING
500 participants
OBSERVATIONAL
2024-10-21
2028-03-31
Brief Summary
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This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.
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Detailed Description
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A) icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (MRI) scans and thereby providing insights into subclinical changes during disease progression in MS.
B) icompanion ms, which consists of i) A free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation.
ii) A web portal for healthcare professionals (HCPs), which is accessible via web browser. The MS care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' MRI images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (PACS).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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People with RRMS
Participants with relapsing-remitting multiple sclerosis (RRMS) will have to complete various questionnaire from which data will be collected for patient-reported outcomes (PROs) using the icompanion patient app and the HCPs will complete various questionnaires using the icompanion HCP portal.
MS Care Platform (icobrain ms and icompanion ms)
The MS care management platform consists of the following components:
1. icobrain ms which is a a cloud-based solution to quantify brain volume and brain abnormalities and changes thereof on MRI scans;
2. icompanion ms which consists of free participant mobile application (app) and a web portal for HCPs.
The information collected in the icompanion ms patient app and icobrain ms is then brought together in the icompanion ms HCP web portal which allows a comprehensive overview of disease data for every single participant.
Interventions
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MS Care Platform (icobrain ms and icompanion ms)
The MS care management platform consists of the following components:
1. icobrain ms which is a a cloud-based solution to quantify brain volume and brain abnormalities and changes thereof on MRI scans;
2. icompanion ms which consists of free participant mobile application (app) and a web portal for HCPs.
The information collected in the icompanion ms patient app and icobrain ms is then brought together in the icompanion ms HCP web portal which allows a comprehensive overview of disease data for every single participant.
Eligibility Criteria
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Inclusion Criteria
* Have a valid email address (for registration of icompanion ms)
* Have a definite diagnosis of RRMS
* Time since MS diagnosis ≥1 year
* Medical history recorded for at least 1 year before enrollment
* Expanded Disability Status Scale (EDSS) \<5.5
Exclusion Criteria
* Inability to complete an MRI
* Currently involved in an interventional trial
* Diagnosis of progressive MS (primary progressive multiple sclerosis \[PPMS\] or secondary progressive multiple sclerosis \[SPMS\])
18 Years
ALL
No
Sponsors
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icometrix
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
icometrix
Locations
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Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jersey Shore University Medical Centre
Neptune City, New Jersey, United States
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Sinsheim, , Germany
Countries
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Central Contacts
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Other Identifiers
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MN44358
Identifier Type: -
Identifier Source: org_study_id
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