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

NCT05816122 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2025-06-13

No results posted yet for this 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 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Conditions

Interventions

DEVICE

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

Sponsors & Collaborators

  • Ad scientiam

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816122 on ClinicalTrials.gov