Clinical trial NCT05816122: MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
Official title: MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 336
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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 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:

* 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.

Primary outcomes:
measure: To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
Secondary outcomes:
measure: To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on EDSS.
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening earlier than the EDSS.
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To evaluate MSCopilot® Detect individual and/or composite scores ability to detect disease progression in absence of a relapsing activity (PIRA).
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To evaluate MSCopilot® Detect individual scores and/or composite scores ability to detect MSFC changes over time.
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To measure MSCopilot® Detect individual scores and/or composite scores association with the clinical scores.
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To assess reproducibility of MSCopilot® Detect individual scores and/or composite scores between in-clinic and at-home digital tests.
timeFrame: At home (Day 1, Month 6+1 day, Month 12 + 1 day, Month 18-1 day and Month 24-1 day (if applicable)) and in-clinic ((Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
measure: To assess reliability of MSCopilot® Detect individual scores and/or composite scores at-home over time.
timeFrame: Day 0 versus Month 6, Month 6 versus Month 12, Month 12 versus Month 18, Month18 versus Month 24 (if applicable) AND Day 0 to Month 18 or Day 0 to Month 24 (if applicable) and Day 0 to Month 15 or Day 0 to Month 21 (if applicable) at home.
measure: To evaluate Patient QoL (Multiple Sclerosis Impact Scale: MSIS-29 and Modified Fatigue Impact Scale - 5-item version: MFIS-5) and their association with MSCopilot® Detect individual and composite scores.
timeFrame: Throughout the study between in clinic visit, an average of 24 months
measure: To evaluate the ability of MSCopilot® Detect individual scores and/or composite score to discriminate between a relapse and a momentary disability worsening (+1 point EDSS score for an initial EDSS <5,5; +0.5 point for an initial EDSS ≥5.5).
timeFrame: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
measure: To evaluate MSCopilot® Detect Safety
timeFrame: Throughout the study between in clinic visit, an average of 24 months
measure: To evaluate MSCopilot® Detect Adherence
timeFrame: Throughout the study between in clinic visit, an average of 24 months
measure: To assess the satisfaction and user experience with the MSCopilot® Detect smartphone application and the MSCopilot® Detect web dashboard.
timeFrame: Every 3 months for about 24 months
measure: To assess the satisfaction and user experience with the MSCopilot® Detect web dashboard.
timeFrame: Every 6 months for about 24 months
measure: To describe the evolution of MSCopilot® Detect individual scores and/or composite scores at-home over time.
timeFrame: Throughout the study between in clinic visit, an average of 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Jennifer Graves
state: California
city: Atlanta
country: United States
facility: Joash Lazarus Sr.
state: Georgia
city: Northbrook
country: United States
facility: Daniel Wynn
state: Illinois
city: Indianapolis
country: United States
facility: Craig E. Herrman
state: Indiana
city: New Orleans
country: United States
facility: Jennifer Feng
state: Louisiana
city: St Louis
country: United States
facility: Robert Naismith
state: Missouri
city: Columbus
country: United States
facility: Aaron Boster
state: Ohio
city: Oklahoma City
country: United States
facility: Gabriel Pardo
state: Oklahoma
city: Portland
country: United States
facility: Vijayshree Yadav
state: Oregon
city: Austin
country: United States
facility: Leorah Freeman
state: Texas
city: Burnaby
country: Canada
facility: Galina Vorobeychik
city: Ottawa
country: Canada
facility: Mark Freedman
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Vancouver
country: Canada
facility: Robert Carruthers
city: Esbjerg
country: Denmark
facility: University Hospital of Southern Denmark
city: Glostrup
country: Denmark
facility: Finn Sellebjerg
city: Viborg
country: Denmark
facility: Sivagini Prakash
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Lomme
country: France
facility: Cécile Donzé
city: Marseille
country: France
facility: Adil Maarouf
city: Nice
country: France
facility: Mikael Cohen
city: Rouen
country: France
facility: Bertrand Bourre
city: Bayreuth
country: Germany
facility: Boris-Alexander Kallman
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Erbach
country: Germany
facility: Rupert Knoblich
city: Florence
country: Italy
facility: Emilio Portaccio
city: Foggia
country: Italy
facility: Emanuele D'Amico
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Girona
country: Spain
facility: Gary Álvarez Bravo
city: Madrid
country: Spain
facility: Enric Monreal
city: Madrid
country: Spain
facility: University Hospital San Carlos
city: Málaga
country: Spain
facility: Ana Alonso
city: Oviedo
country: Spain
facility: Miguel Llaneza
city: Zaragoza
country: Spain
facility: Jesùs Martin
Study officials:
References: