Clinical trial NCT06526364: Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Luxembourg Institute of Health
name: Research Center for Clinical Neuroimmunology and Neuroscience Basel
First posted: 2024-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Multiple Sclerosis (MS) is a chronic disease of the central nervous system that causes a range of neurological symptoms, such as cognitive issues, fatigue, vision problems, and muscle weakness. There are two main forms: relapsing-remitting MS (RRMS) with episodes of symptoms that improve on their own, and primary progressive MS (PPMS) with chronically worsening symptoms. Many RRMS patients eventually develop secondary progressive MS (SPMS), where disability worsens without remissions. What causes MS remains unknown, but it is thought to involve genetic and environmental factors. Diagnosis and monitoring typically involve patient history, neurologic examination in combination with magnetic resonance imaging (MRI), and other tests, but these methods are costly and time-consuming. Efforts are made to develop digital tools for continuous patients monitoring.

This study is part of the Clinnova programme, aiming to collect standardized and high-quality digital health data. Clinnova-MS is a prospective cohort study including patients with early MS or those transitioning to progressive MS. Up to 100 patients, recruited from the ongoing Swiss MS cohort study, are enrolled in Basel, Switzerland. An equivalent number of patients are enrolled in other Clinnova centers, reaching at least 800 patients in total. The study aims to provide a structured and standardized highly granular dataset, allowing for the phenotyping of patients with similar patterns and disease courses. It also facilitates transnational data linkage the analysis of complex and heterogeneous data from MS patients.

The primary objective of the study is to derive a set of biomarkers that will better characterize the clinical phenotype and progression of the disease, as well as the functional impairment of MS patients at different stages. These biomarkers will aid clinicians in making informed treatment decisions for patients with early MS or those transitioning to progressive MS.

Eligibility criteria: Inclusion Criteria:

* 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

There are no specific exclusion criteria.

Primary outcomes:
measure: Set of biomarkers
timeFrame: 2029
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline and once a year for up to 5 years
measure: 9-Hole Peg Test (9-HPT)
timeFrame: Baseline and once a year for up to 5 years
measure: Timed 25-Foot Walk (T25FW)
timeFrame: Baseline and once a year for up to 5 years
measure: Stroop Test (Victoria Version)
timeFrame: Baseline and once a year for up to 5 years
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and once a year for up to 5 years
measure: Trail Making Test A&B (TMT A&B)
timeFrame: Baseline and once a year for up to 5 years
measure: Multiple Sclerosis Inventory of Cognition (MUSIC)
timeFrame: Baseline and once a year for up to 5 years
measure: Digit span backwards (DSB)
timeFrame: Baseline and once a year for up to 5 years
measure: Rey-Osterrieth Complex Figure Test (ROCF)
timeFrame: Baseline and once a year for up to 5 years
measure: Verbal Learn and Memory Test (VLMT)
timeFrame: Baseline and once a year for up to 5 years
measure: Near vision acuity test
timeFrame: Baseline and once a year for up to 5 years
measure: Contrast vision test (Pelli-Robson low-contrast chart)
timeFrame: Baseline and once a year for up to 5 years
measure: Short-form Food Frequency Questionnaire (SFFFQ)
timeFrame: Baseline and once a year for up to 5 years
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline every 6 months for up to 5 years
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline every 6 months for up to 5 years
measure: MS Symptom Tracker
timeFrame: Baseline every 6 months for up to 5 years
measure: Relapse reporting
timeFrame: Baseline every 6 months for up to 5 years
measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54)
timeFrame: Baseline and once a year for up to 5 years
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and once a year for up to 5 years
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
timeFrame: Baseline and once a year for up to 5 years
measure: PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a
timeFrame: Baseline and once a year for up to 5 years
measure: PROMIS Short Form v1.1 - Pain Interference 4a
timeFrame: Baseline and once a year for up to 5 years
measure: PROMIS Short Form v2.0 - Cognitive Function - Abilities 8a
timeFrame: Baseline and once a year for up to 5 years
measure: PROMIS Scale v1.2 - Global Health
timeFrame: Baseline and once a year for up to 5 years
measure: electronic Health Literacy Scale (eHEALS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
Study officials:
affiliation: Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
name: Cristina Granziera, Prof.
role: PRINCIPAL_INVESTIGATOR
References: