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
Ad scientiam
144 participants
Jan 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria8
- 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.
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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.
Locations(19)
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NCT05564936