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

NCT05816122 | Active Not Recruiting FDA Device

• 1 other identifier: MS-DETECT
• Study Type: interventional
• Target: 336
• Locations: 7 countries
• Sites: 34

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.

  The discriminatory ability of the MSCopilot® Detect application in detecting clinically meaningful worsening (disability worsening) based on the revised-MSFC will be evaluated using the Area Under the ROC Curve (AUC) method. Confidence intervals will also be estimated. The minimum significant AUC value will be set at \>0.67, and Confidence Intervals will be calculated. Sensitivity and specificity will also be determined. To validate the estimated AUC values and cutoffs generated by the MSCopilot® Detect application, a train/test set will be utilised.

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

Secondary Outcomes (14)

• To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on EDSS.

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

• To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening earlier than the EDSS.

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

• To evaluate MSCopilot® Detect individual and/or composite scores ability to detect disease progression in absence of a relapsing activity (PIRA).

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

• To evaluate MSCopilot® Detect individual scores and/or composite scores ability to detect MSFC changes over time.

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

• To measure MSCopilot® Detect individual scores and/or composite scores association with the clinical scores.

  Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)

Study Arms (1)

MSCopilot® Detect

EXPERIMENTAL

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)

Device: MSCopilot® Detect mobile application

Interventions

MSCopilot® Detect mobile application DEVICE

MSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life

MSCopilot® Detect

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (34)

Jennifer Graves

San Diego, California, 92093, United States

Location

Joash Lazarus Sr.

Atlanta, Georgia, 30327, United States

Location

Daniel Wynn

Northbrook, Illinois, 60062, United States

Location

Craig E. Herrman

Indianapolis, Indiana, 46256, United States

Location

Jennifer Feng

New Orleans, Louisiana, 70121, United States

Location

Robert Naismith

St Louis, Missouri, 63110, United States

Location

Aaron Boster

Columbus, Ohio, 43235, United States

Location

Gabriel Pardo

Oklahoma City, Oklahoma, 73104, United States

Location

Vijayshree Yadav

Portland, Oregon, 97239-3098, United States

Location

Leorah Freeman

Austin, Texas, 78712, United States

Location

Galina Vorobeychik

Burnaby, Canada

Location

Mark Freedman

Ottawa, Canada

Location

St. Michael's Hospital

Toronto, Canada

Location

Robert Carruthers

Vancouver, Canada

Location

University Hospital of Southern Denmark

Esbjerg, Denmark

Location

Finn Sellebjerg

Glostrup Municipality, Denmark

Location

Sivagini Prakash

Viborg, Denmark

Location

Hôpital Roger Salengro

Lille, France

Location

Cécile Donzé

Lomme, France

Location

Adil Maarouf

Marseille, France

Location

Mikael Cohen

Nice, France

Location

Bertrand Bourre

Rouen, France

Location

Boris-Alexander Kallman

Bayreuth, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Rupert Knoblich

Erbach im Odenwald, Germany

Location

Emilio Portaccio

Florence, Italy

Location

Emanuele D'Amico

Foggia, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Gary Álvarez Bravo

Girona, Spain

Location

Enric Monreal

Madrid, Spain

Location

University Hospital San Carlos

Madrid, Spain

Location

Ana Alonso

Málaga, Spain

Location

Miguel Llaneza

Oviedo, Spain

Location

Jesùs Martin

Zaragoza, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 18, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); ES (6); IT (3); DK (3); FR (5); DE (3); CA (4)