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

Multiple Sclerosis Clinical Trial

— MSST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04595799
• Other study ID #: 20-AOI-01
• Status: Active, not recruiting
• Start date: November 9, 2020
• Est. completion date: November 9, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: November 9, 2025
• Est. primary completion date: November 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
France	Lille University Hospital	Lille
France	LYON Civil Hospital	Lyon
France	Montpellier university hospital	Montpellier
France	Nice University Hospital	Nice
France	Nimes University Hospital	Nîmes
France	Paris University Hospital - la pitié salpétriere	Paris
France	Rennes University Hospital	Rennes
France	Rouen University hospital	Rouen
France	Strasbourg University Hospital	Strasbourg
France	Toulouse university hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	speed test in MMST results	the average speed (in taps per second or Hz) for the dominant and non-dominant hand	12 months
Primary	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
Primary	synchronization test in MMST results	the average time interval expressed in milliseconds separating the left and right index strokes.	12 months
Primary	visual test in MMST results	number of letters seen	12 months
Primary	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