MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
NCT ID: NCT05816122
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
336 participants
INTERVENTIONAL
2023-09-22
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis.
NCT04595799
Multiple Sclerosis Falls Insight Track
NCT05837949
Multiple Sclerosis Prediction and Monitoring of Progression Study
NCT05685784
Prospective Investigation of Multiple Sclerosis in the Three Rivers Region
NCT02994121
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition
NCT05781113
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MSCopilot® Detect
Performance of digital tests and standard test in clinic at D0, M6, M12, M18 and M24 (if applicable) Use of MSCopilot® Detect at-home in between visits during 18 or 24 months (if applicable)
MSCopilot® Detect mobile application
MSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MSCopilot® Detect mobile application
MSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
30 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ad scientiam
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jennifer Graves
San Diego, California, United States
Joash Lazarus Sr.
Atlanta, Georgia, United States
Daniel Wynn
Northbrook, Illinois, United States
Craig E. Herrman
Indianapolis, Indiana, United States
Jennifer Feng
New Orleans, Louisiana, United States
Robert Naismith
St Louis, Missouri, United States
Aaron Boster
Columbus, Ohio, United States
Gabriel Pardo
Oklahoma City, Oklahoma, United States
Vijayshree Yadav
Portland, Oregon, United States
Leorah Freeman
Austin, Texas, United States
Galina Vorobeychik
Burnaby, , Canada
Mark Freedman
Ottawa, , Canada
St. Michael's Hospital
Toronto, , Canada
Robert Carruthers
Vancouver, , Canada
University Hospital of Southern Denmark
Esbjerg, , Denmark
Finn Sellebjerg
Glostrup Municipality, , Denmark
Sivagini Prakash
Viborg, , Denmark
Hôpital Roger Salengro
Lille, , France
Cécile Donzé
Lomme, , France
Adil Maarouf
Marseille, , France
Mikael Cohen
Nice, , France
Bertrand Bourre
Rouen, , France
Boris-Alexander Kallman
Bayreuth, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Rupert Knoblich
Erbach im Odenwald, , Germany
Emilio Portaccio
Florence, , Italy
Emanuele D'Amico
Foggia, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Gary Álvarez Bravo
Girona, , Spain
Enric Monreal
Madrid, , Spain
University Hospital San Carlos
Madrid, , Spain
Ana Alonso
Málaga, , Spain
Miguel Llaneza
Oviedo, , Spain
Jesùs Martin
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MS-DETECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.