MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect

Description

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Conditions

Multiple Sclerosis

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Study Overview

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Study Details

Study overview

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect

MS-DETECT: Early Detection of Multiple Sclerosis Progression with MSCopilot® Detect

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

San Diego

Jennifer Graves, San Diego, California, United States, 92093

Atlanta

Joash Lazarus Sr., Atlanta, Georgia, United States, 30327

Northbrook

Daniel Wynn, Northbrook, Illinois, United States, 60062

Indianapolis

Craig E. Herrman, Indianapolis, Indiana, United States, 46256

New Orleans

Jennifer Feng, New Orleans, Louisiana, United States, 70121

St Louis

Robert Naismith, St Louis, Missouri, United States, 63110

Columbus

Aaron Boster, Columbus, Ohio, United States, 43235

Oklahoma City

Gabriel Pardo, Oklahoma City, Oklahoma, United States, 73104

Portland

Vijayshree Yadav, Portland, Oregon, United States, 97239-3098

Austin

Leorah Freeman, Austin, Texas, United States, 78712

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult patients living with RRMS or SPMS, aged 30 to 65
  • * EDSS score between 2.5 to 6.5 points
  • * With a disease duration \> 5 years
  • * Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
  • * No change in the DMT\* during the last 3 months before inclusion
  • * Receiving optimal symptomatic treatments at baseline (clinician's judgment)
  • * Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
  • * Able to use a smartphone
  • * Able to read language in wich the mobile application is available and able to understand pictograms.
  • * Applicable to patients enrolled in France only: affiliated to a social security system.
  • * Medically unstable conditions that may hinder patient's ability to comply with the study procedures
  • * Inability to use a smartphone or MSCopilot® Detect application
  • * Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
  • * Pregnancy and nursing women
  • * Persons under guardianship or curatorship
  • * Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  • * Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.

Ages Eligible for Study

30 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ad scientiam,

Study Record Dates

2026-12-31