Clinical trial NCT04595799: Use of a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis.
Official title: MS Screen Test: Using a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed multiple sclerosis starting first-line background therapy

Brief summary: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease the risk of long-term disability progression.

One of the current unmet needs is to have markers that can be used at the individual level to predict the long-term prognosis in order to propose optimal and personalized therapeutic management.

Classically used clinical markers do not meet this need. It is recognized that there is a so-called silent course of MS (not measurable by clinical parameters), which may, after several months or years, be expressed as a physical or cognitive disability.

MRI is the reference examination for monitoring the sub-clinical activity of the disease but it does not allow the neurodegenerative side of the disease to be assessed. Other blood or imaging markers are being studied but are not yet usable in daily practice.

The project aims to evaluate the interest in using digital biomarkers, based on a rapid assessment of patients using a locally developed mobile application (MS Screen Test - MSST) to predict the evolutionary prognosis of the disease.


Eligibility criteria: Inclusion Criteria:

* Patient between 18 and 60 years of age
* Presenting a diagnosis of relapsing-remitting MS defined according to McDonald 2017 criteria confirmed within 6 months prior to inclusion
* Starting first-line treatment (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate)
* Having an encephalic and cervical MRI in OFSEP format, within 6 months prior to inclusion
* No relapse within 30 days prior to inclusion

Exclusion Criteria:

* presence of a motor, visual or cognitive deficit not related to MS

Primary outcomes:
measure: speed test in MMST results
timeFrame: 12 months
measure: agility test in MMST results
timeFrame: 12 months
measure: synchronization test in MMST results
timeFrame: 12 months
measure: visual test in MMST results
timeFrame: 12 months
measure: Cognitive test in MMST results
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: LYON Civil Hospital
city: Montpellier
country: France
facility: Montpellier university hospital
city: Nice
country: France
facility: Nice University Hospital
city: Nîmes
country: France
facility: Nimes University Hospital
city: Paris
country: France
facility: Paris University Hospital - la pitié salpétriere
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse university hospital
Study officials:
References: