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RECRUITINGINTERVENTIONAL

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

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Treatments Being Tested

DEVICE

ME&MG mobile application

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.

Locations (19)

University of Colorado Denver
Aurora, Colorado, United States
University of Florida Health
Jacksonville, Florida, United States
HealthParterns Institute
Bloomington, Indiana, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Neurological Associates of Long Island, P.C.
Lake Success, New York, United States
Duke University
Durham, North Carolina, United States
OHSU
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
Vanderbilt Health
Nashville, Tennessee, United States
Hôpital Raymond Poincaré
Garches, France
CHU Grenoble
Grenoble, France
Hôpital Salengro
Lille, France
CHRU Nancy
Nancy, France
CHU Nantes
Nantes, France
Pitié-Salpêtrière
Paris, France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
CHU Toulouse
Toulouse, France