Use of a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis.

NCT ID: NCT04595799

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-09

Study Completion Date

2025-11-09

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lille University Hospital

Lille, , France

Site Status

LYON Civil Hospital

Lyon, , France

Site Status

Montpellier university hospital

Montpellier, , France

Site Status

Nice University Hospital

Nice, , France

Site Status

Nimes University Hospital

Nîmes, , France

Site Status

Paris University Hospital - la pitié salpétriere

Paris, , France

Site Status

Rennes University Hospital

Rennes, , France

Site Status

Rouen University hospital

Rouen, , France

Site Status

Strasbourg University Hospital

Strasbourg, , France

Site Status

Toulouse university hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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20-AOI-01

Identifier Type: -

Identifier Source: org_study_id

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