RecruitingNCT06526364

Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)

Clinnova-MS: a Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (Switzerland)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

100 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive

Summary

This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Swiss observational study is tracking people with multiple sclerosis (MS) over time to understand how the disease progresses and how treatments affect outcomes. Participants will have their health tracked through clinic visits, blood samples, and data from a smartphone app, helping researchers build a more complete picture of MS across all its forms. **You may be eligible if...** - You are 18 or older - You have been diagnosed with MS according to updated 2017 criteria — including relapsing-remitting MS, secondary progressive MS, primary progressive MS, or clinically isolated syndrome - You are either in an early stage of MS (less than 3 years since diagnosis) or transitioning to a progressive phase - You are enrolled in the MS clinic at University Hospital Basel, Switzerland - You own or can use a smartphone compatible with the Healios+Me app - You have sufficient vision and hand motor skills to use a smartphone **You may NOT be eligible if...** - There are no specific exclusion criteria listed for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAll participants will be asked to provide data and samples for collection and analysis.

During the first year, data related to demographics, lifestyle, clinical examinations will be collected at baseline, at 6 months (optional) and at 12 months. PROs, cognitive and motor assessments will be performed using the Healios+Me smartphone app. Additionally, participants will be asked to provide biological samples (i.e., blood, cerebrospinal fluid and stool, saliva and hair) and imaging data (if performed as per standard of care). One unscheduled visit may be performed in case the participant comes to the hospital with the occurrence of flare or for a treatment change. A long-term follow-up (FU, starting from month 12 and up to 4 years after month 12) is foreseen in this study. During the long-term FU medical data are collected either every 6 month or on a yearly basis, and PROs are collected every 6 months. Whether study visits are conducted in 6- or 12-monthly intervals depends on the schedule of the study visits for the Swiss MS cohort (SMSC).

Locations(1)

Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Basel, Switzerland

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