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

NCT04595799 | Active Not Recruiting

• 1 other identifier: 20-AOI-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 10

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient between 18 and 60 years of age
• Starting first-line treatment (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (10)

Lille University Hospital

Lille, 59037, France

Location

LYON Civil Hospital

Lyon, 69000, France

Location

Montpellier university hospital

Montpellier, 34295, France

Location

Nice University Hospital

Nice, 06000, France

Location

Nimes University Hospital

Nîmes, 30900, France

Location

Paris University Hospital - la pitié salpétriere

Paris, 75013, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Rouen University hospital

Rouen, 76031, France

Location

Strasbourg University Hospital

Strasbourg, 67000, France

Location

Toulouse university hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 22, 2020
• Study Start: November 9, 2020
• Primary Completion: November 9, 2025
• Study Completion: November 9, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

FR (10)