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

NCT06526364 | Recruiting

• 1 other identifier: 2023-01640; ko23Granziera
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Immune-meditated Diseases; Artificial Intelligence; Personalized medicine; Treatment change; Phenotyping; Clinnova

Outcome Measures

Primary Outcomes (1)

• Set of biomarkers

  To identify clinical, imaging and omics characteristics associated with early MS and with transitioning phases to progressive MS, a set of biomarkers is derived that allows in the future to better characterize the disease clinical phenotype and progression, the functional impairment of MS patients in different disease stages, and either associated with early MS or with transitioning phase to progressive MS, as an aid to assist clinicians in applying treatment change.

  2029

Secondary Outcomes (25)

• Expanded Disability Status Scale (EDSS)

  Baseline and once a year for up to 5 years

• 9-Hole Peg Test (9-HPT)

  Baseline and once a year for up to 5 years

• Timed 25-Foot Walk (T25FW)

  Baseline and once a year for up to 5 years

• Stroop Test (Victoria Version)

  Baseline and once a year for up to 5 years

• Symbol Digit Modalities Test (SDMT)

  Baseline and once a year for up to 5 years

Study Arms (1)

MS patients

MS patients, recruited from the SMSC, are annually (optional 6-monthly) assessed and additionally, perform digital measurements with the Healios+Me app continuously after baseline up to 5 years as an optional follow-up study extension.

Other: All participants will be asked to provide data and samples for collection and analysis.

Interventions

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

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).

MS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS are be recruited from the ongoing clinical cohort (SMSC), where participants have annual (optional 6-monthly) visits with a well-defined assessment schedule.

You may qualify if:

• Age ≥18
• Participants are willing and able to comply with the protocol, including undergoing data and samples collection as well as study visits and examinations.
• Signed informed consent form
• In possession of a Healios+Me app compatible smartphone (iOS/Android)
• Corrected close visual acuity of ≥0.5
• Hand motor skills sufficient for using a smartphone
• Ability to follow the study procedures
• Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (clinically isolated syndrome, RRMS, SPMS, PPMS) AND early disease stages (\< 3 years) OR transitioning phase to progressive disease as evaluated based on Expanded Disability Status Scale (EDSS).
• Enrolled in the SMSC at University Hospital Basel

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Luxembourg Institute of Health: collaborator
• Research Center for Clinical Neuroimmunology and Neuroscience Basel: collaborator

Study Sites (1)

Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Basel, 4031, Switzerland

RECRUITING

Related Links

• CLINNOVA website

Biospecimen

Retention: SAMPLES WITH DNA

Blood (50 ml per visit), Optional: Cerebrospinal fluid (at diagnosis), stool, saliva, and hair samples

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Granziera, Prof.

  Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bebeka Cosandey (Clinnova:Scientific Project Lead), PhD

CONTACT

+41 79 961 26 31; bebeka.cosandey@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 29, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CH (1)