ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Official Title

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

Quick Facts

Study Start:2023-09-22
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05816122

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.

Ages Eligible for Study:30 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients living with RRMS or SPMS, aged 30 to 65
  2. * EDSS score between 2.5 to 6.5 points
  3. * With a disease duration \> 5 years
  4. * Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
  5. * No change in the DMT\* during the last 3 months before inclusion
  6. * Receiving optimal symptomatic treatments at baseline (clinician's judgment)
  7. * Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
  8. * Able to use a smartphone
  9. * Able to read language in wich the mobile application is available and able to understand pictograms.
  10. * Applicable to patients enrolled in France only: affiliated to a social security system.
  1. * Medically unstable conditions that may hinder patient's ability to comply with the study procedures
  2. * Inability to use a smartphone or MSCopilot® Detect application
  3. * Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
  4. * Pregnancy and nursing women
  5. * Persons under guardianship or curatorship
  6. * Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  7. * 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.

Contacts and Locations

Study Locations (Sites)

Jennifer Graves
San Diego, California, 92093
United States
Joash Lazarus Sr.
Atlanta, Georgia, 30327
United States
Daniel Wynn
Northbrook, Illinois, 60062
United States
Craig E. Herrman
Indianapolis, Indiana, 46256
United States
Jennifer Feng
New Orleans, Louisiana, 70121
United States
Robert Naismith
St Louis, Missouri, 63110
United States
Aaron Boster
Columbus, Ohio, 43235
United States
Gabriel Pardo
Oklahoma City, Oklahoma, 73104
United States
Vijayshree Yadav
Portland, Oregon, 97239-3098
United States
Leorah Freeman
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: Ad scientiam

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis