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

MS Screen Test: Using a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Lille University Hospital
  • Lyon, France, 69000
    • LYON Civil Hospital
  • Montpellier, France, 34295
    • Montpellier University Hospital
  • Nice, France, 06000
    • Nice University Hospital
  • Nîmes, France, 30900
    • Nimes University Hospital
  • Paris, France, 75013
    • Paris University Hospital - la pitié salpétriere
  • Rennes, France, 35033
    • Rennes University Hospital
  • Rouen, France, 76031
    • Rouen University Hospital
  • Strasbourg, France, 67000
    • Strasbourg University Hospital
  • Toulouse, France, 31059
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed multiple sclerosis starting first-line background therapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
speed test in MMST results	the average speed (in taps per second or Hz) for the dominant and non-dominant hand	12 months
agility test in MMST results	time required (in seconds) to bring the ball to the target as well as the actual time the ball will be held inside the target (expressed as a percentage of the total recording time)	12 months
synchronization test in MMST results	the average time interval expressed in milliseconds separating the left and right index strokes.	12 months
visual test in MMST results	number of letters seen	12 months
Cognitive test in MMST results	the average response latency (the time in milliseconds between the display and the click on a good answer) expressed in milliseconds, the number of wrong answers as well as the number of missed letters. the average response latency is the combination of multiple measurements (time of response, number of wrong answers and number of missed letters.	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Estimated): November 9, 2025
• Study Completion (Estimated): November 9, 2025

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 20-AOI-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No