Status:
RECRUITING
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
icometrix
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practic...
Detailed Description
The MS care management platform consists of: A) icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic reson...
Eligibility Criteria
Inclusion Criteria:
- Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
- 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:
- Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
- 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])
Key Trial Info
Start Date :
October 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05949580
Start Date
October 21 2024
End Date
March 31 2028
Last Update
January 20 2026
Active Locations (5)
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1
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Jersey Shore University Medical Centre
Neptune City, New Jersey, United States, 07753
4
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany, 01307