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

May 13, 2022 updated by: Centre Hospitalier Universitaire de Nice

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
      • Lyon, France, 69000
        • Recruiting
        • LYON Civil Hospital
      • Montpellier, France, 34295
      • Nice, France, 06000
        • Recruiting
        • Nice University Hospital
        • Contact:
        • Principal Investigator:
          • mikael COHEN
      • Nîmes, France, 30900
        • Recruiting
        • Nîmes University Hospital
        • Contact:
        • Principal Investigator:
          • Eric THOUVENOT
      • Paris, France, 75013
        • Recruiting
        • Paris University Hospital - la pitié salpétriere
        • Contact:
        • Principal Investigator:
          • elisabeth MAILLART
      • Rennes, France, 35033
        • Recruiting
        • Rennes University Hospital
        • Sub-Investigator:
          • Emmanuelle Lepage
      • Rouen, France, 76031
      • Strasbourg, France, 67000
      • Toulouse, France, 31059
        • Recruiting
        • Toulouse University Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan CIRON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speed test in MMST results
Time Frame: 12 months
the average speed (in taps per second or Hz) for the dominant and non-dominant hand
12 months
agility test in MMST results
Time Frame: 12 months
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
Time Frame: 12 months
the average time interval expressed in milliseconds separating the left and right index strokes.
12 months
visual test in MMST results
Time Frame: 12 months
number of letters seen
12 months
Cognitive test in MMST results
Time Frame: 12 months

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Anticipated)

November 9, 2022

Study Completion (Anticipated)

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 16, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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