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

Description

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.

Conditions

Myasthenia Gravis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Jacksonville

University of Florida Health, Jacksonville, Florida, United States, 32209

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46123

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Lake Success

Neurological Associates of Long Island, P.C., Lake Success, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 Years to 60 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
  • * Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ad scientiam,

Study Record Dates

2025-09-15