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

Last updated: December 4, 2024
Sponsor: Ad scientiam
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

MSCopilot® Detect mobile application

Clinical Study ID

NCT05816122
MS-DETECT
  • Ages 30-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion 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, nodisability 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 tounderstand pictograms.

  • Applicable to patients enrolled in France only: affiliated to a social securitysystem.

Exclusion

Exclusion Criteria:

  • Medically unstable conditions that may hinder patient's ability to comply with thestudy 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 ofscreening or are currently participating in another study that, in the opinion ofthe Investigator, might interfere with the patient's full participation in the studyor confound the assessment of the patient or outcome of the study.

Study Design

Total Participants: 314
Treatment Group(s): 1
Primary Treatment: MSCopilot® Detect mobile application
Phase:
Study Start date:
September 22, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Galina Vorobeychik

    Burnaby,
    Canada

    Active - Recruiting

  • Mark Freedman

    Ottawa,
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto,
    Canada

    Site Not Available

  • Robert Carruthers

    Vancouver,
    Canada

    Active - Recruiting

  • University Hospital of Southern Denmark

    Esbjerg,
    Denmark

    Active - Recruiting

  • Finn Sellebjerg

    Glostrup,
    Denmark

    Active - Recruiting

  • Helene Hoejsgaard Chow

    Glostrup,
    Denmark

    Site Not Available

  • Henrik Boye Jensen

    Kolding,
    Denmark

    Site Not Available

  • Sivagini Prakash

    Viborg,
    Denmark

    Site Not Available

  • Hôpital Roger Salengro

    Lille,
    France

    Active - Recruiting

  • Cécile Donzé

    Lomme,
    France

    Active - Recruiting

  • Adil Maarouf

    Marseille,
    France

    Active - Recruiting

  • Mikael Cohen

    Nice,
    France

    Active - Recruiting

  • Bertrand Bourre

    Rouen,
    France

    Active - Recruiting

  • Boris-Alexander Kallman

    Bayreuth,
    Germany

    Active - Recruiting

  • Felix Bischof

    Böblingen,
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden,
    Germany

    Active - Recruiting

  • Rupert Knoblich

    Erbach,
    Germany

    Active - Recruiting

  • Damiano Paolicelli

    Bari,
    Italy

    Site Not Available

  • Emilio Portaccio

    Florence,
    Italy

    Active - Recruiting

  • Emanuele D'Amico

    Foggia,
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Carla Tortorella

    Roma,
    Italy

    Site Not Available

  • Gary Álvarez Bravo

    Girona,
    Spain

    Active - Recruiting

  • Lluís Ramió

    Girona,
    Spain

    Site Not Available

  • Enric Monreal

    Madrid,
    Spain

    Active - Recruiting

  • University Hospital San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Ana Alonso

    Málaga,
    Spain

    Active - Recruiting

  • Miguel Llaneza

    Oviedo,
    Spain

    Site Not Available

  • Jesùs Martin

    Zaragoza,
    Spain

    Active - Recruiting

  • Jennifer Graves

    San Diego, California 92093
    United States

    Active - Recruiting

  • Joash Lazarus Sr.

    Atlanta, Georgia 30327
    United States

    Active - Recruiting

  • Daniel Wynn

    Northbrook, Illinois 60062
    United States

    Active - Recruiting

  • Craig E. Herrman

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Jennifer Feng

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Robert Naismith

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Aaron Boster

    Columbus, Ohio 43235
    United States

    Active - Recruiting

  • Gabriel Pardo

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Oklahoma Medical Research Foundation,

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Vijayshree Yadav

    Portland, Oregon 97239-3098
    United States

    Active - Recruiting

  • Leorah Freeman

    Austin, Texas 78712
    United States

    Active - Recruiting

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