ClinicalTrials.gov ID: NCT05816122
Ages Eligible: 30 to 65 Years
Sexes Eligible: All
Study Phase: Not Applicable
Study Completion (Estimated): 2026-09-30
Principal Investigator: Theodore Brown, MD, MPH
Contact Information:
EvergreenHealth Research Department
425-899-5385
EvergreenResearch@evergreenhealthcare.org
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).
Eligibility Criteria:
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, 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 connection
- Able to use a smartphone
- Able to read language in which the mobile application is available and able to understand pictograms.
Exclusion Criteria
- 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.
