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.
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)
None
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.
Cohort
Prospective
All participants will be asked to provide data and samples for collection and analysis.
Other interventionDuring 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).
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.
Expanded Disability Status Scale (EDSS)
To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Expanded Disability Status Scale (EDSS) is assessed. The EDSS is a standardized method used to quantify disability in MS patients. The scale ranges from 0 to 10, with lower scores indicating minimal or no disability and higher scores indicating severe disability. Scores are determined based on assessments of motor function, sensory function, coordination, and other neurological functions.
9-Hole Peg Test (9-HPT)
To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the 9-Hole Peg Test (9-HPT) is performed. The 9-HPT evaluates manual dexterity by measuring the time it takes for the participant to move nine pegs from a box into nine holes on a board and back. Lower times indicate better dexterity and hand function, while higher times suggest greater impairment. The test will be carried out twice per hand, starting with the dominant hand, and the best performance will be used.
Timed 25-Foot Walk (T25FW)
To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Timed 25-Foot Walk (T25FW) is performed. The T25FW measures the time it takes for the patient to walk a distance of 25 ft (7,62 m) in their usual manner. Shorter times indicate better walking ability and mobility, while longer times suggest greater impairment.
Stroop Test (Victoria Version)
To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Stroop Test (Victoria Version) is performed. The Stroop Test measures processing speed and inhibition ability. First round: Participant is presented with 24 coloured dots and is asked to name the colour of the dots as fast as possible. Second round: Participant sees coloured random words (when, and, hard, over) and is asked to name the colour of each word as fast as possible. Third round: Participants is presented with 24 coloured words spelling colours (and the printed colour of the word is not the same as spelled colour), and is asked to name the printed colour as fast as possible. The test gives three scores based on the number of completed items in each round, and interference scores can be calculated.
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University Hospital, Basel, Switzerland
Lead sponsor
Luxembourg Institute of Health
Collaborator
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Collaborator
