The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
1 other identifier
interventional
144
2 countries
19
Brief Summary
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedStudy Start
First participant enrolled
January 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2026
ExpectedApril 11, 2025
April 1, 2025
1.7 years
September 27, 2022
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions
Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests
baseline
Secondary Outcomes (13)
To compare results between in-clinic digital tests and in-clinic standard tests, test to test
baseline
To assess reproducibility between in-clinic digital tests and at-home digital tests
baseline, day 1, day 89, day 90
To assess test-retest reliability of at-home digital tests
Day1, Day 2, Day 3, Day 87, Day 88, Day 89
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score
baseline, day 1
To assess adverse events related to the use of the mobile application
through study completion, an average of 1 year
- +8 more secondary outcomes
Study Arms (2)
MG patients
EXPERIMENTALMG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months
Healthy volunteers
OTHERHealthy volunteers will perform one in-clinic visit and will use the app at-home once
Interventions
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
Eligibility Criteria
You may qualify if:
- Aged over 18 Years
- Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
- With positive serologic testing for anti-AChR autoantibody at screening
- Have read the information sheet and signed the informed consent form
- Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
- Able to use a smartphone
- Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms
You may not qualify if:
- Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
- Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Pregnant and nursing women
- Person under guardianship or curatorship
- Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
- Participant included in another ME\&MG clinical study
- Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ad scientiamlead
Study Sites (19)
University of Colorado Denver
Aurora, Colorado, 80204, United States
University of Florida Health
Jacksonville, Florida, 32209, United States
HealthParterns Institute
Bloomington, Indiana, 47401, United States
Indiana University Health
Indianapolis, Indiana, 46123, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Neurological Associates of Long Island, P.C.
Lake Success, New York, 11042, United States
Duke University
Durham, North Carolina, 27708, United States
OHSU
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Vanderbilt Health
Nashville, Tennessee, 37232, United States
Hôpital Raymond Poincaré
Garches, 92380, France
CHU Grenoble
Grenoble, France
Hôpital Salengro
Lille, France
CHRU Nancy
Nancy, 54035, France
CHU Nantes
Nantes, France
Pitié-Salpêtrière
Paris, 75013, France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200, France
CHU Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 4, 2022
Study Start
January 24, 2024
Primary Completion
September 24, 2025
Study Completion (Estimated)
September 24, 2026
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share