The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

Last updated: April 8, 2025
Sponsor: Ad scientiam
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

ME&MG mobile application

Clinical Study ID

NCT05564936
DOMYA
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged over 18 Years

  • Diagnosed with gMG at screening with generalized muscle weakness meeting theclinical criteria for diagnosis of MG, as defined by the MGFA ClinicalClassification Class II, III, or IV, and likely not in need of a respirator for theduration 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 forAndroid 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

Exclusion

Exclusion Criteria:

  • Subjects having undergone thymectomy Plasma Exchange Therapy or IntravenousImmunoglobulin Therapy within four weeks of screening

  • Subjects having initiated FcRn inhibitor therapy within the four weeks precedingscreening

  • Known medical or psychological condition(s) or risk factor(s) that, as judged by theinvestigator, might interfere with the subject's full participation in the study,pose any additional risk for the subject, or confound the assessment of the subjector 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, asjudged by the investigator

  • Participant included in another ME&MG clinical study

  • Participant has participated in another clinical study within the previous 30 daysof screening or is currently participating in another study that, in the opinion ofthe Investigator, might interfere with the subject's full participation in the studyor confound the assessment of the subject or outcome of the study.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: ME&MG mobile application
Phase:
Study Start date:
January 24, 2024
Estimated Completion Date:
September 24, 2026

Study Description

Myasthenia gravis (MG) is an autoimmune neuromuscular disease characterised by fatigable muscle weakness due to autoantibodies targeting components of the neuromuscular junction.

Deficits are measured using validated clinical scales such as the Quantitative Myasthenia Gravis score (QMG) QMG, Myasthenia Gravis Composite Score (MCS), Myasthenia Gravis Activities of Daily Living score (MG-ADL), etc., Unfortunately, this type of assessment might require expensive material, time, and personnel training, which make MG assessment difficult for clinicians in routine care.

Research on the matter has highlighted the importance of Patient-Reported Outcomes (PROs), composite measures of disease severity and quality-of-life measurements. This has led to the development of a number of tools for the self-assessment of PROs with validated questionnaires. However, there is no tool that overcomes the constraints of standard tests such as the QMG while allowing for the collection of objective data and PROs between visits.

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.

Connect with a study center

  • Hôpital Raymond Poincaré

    Garches, 92380
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • Hôpital Salengro

    Lille,
    France

    Active - Recruiting

  • CHRU Nancy

    Nancy, 54035
    France

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200
    France

    Completed

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • University of Colorado Denver

    Aurora, Colorado 80204
    United States

    Active - Recruiting

  • University of Florida Health

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • HealthParterns Institute

    Bloomington, Indiana 47401
    United States

    Completed

  • Indiana University Health

    Indianapolis, Indiana 46123
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Neurological Associates of Long Island, P.C.

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27708
    United States

    Active - Recruiting

  • OHSU

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19144
    United States

    Active - Recruiting

  • The University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Vanderbilt Health

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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