The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAd scientiam
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ME&MG mobile application
DeviceME\&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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: MG patientsExperimental treatment 1 intervention
Group B: Healthy volunteersOther 1 intervention
Trial outcomes
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
Time frame
baselineSecondary outcomes
1
To compare results between in-clinic digital tests and in-clinic standard tests, test to test
pearson correlation coefficient between digital tests and standard tests
Time frame
baseline2
To assess reproducibility between in-clinic digital tests and at-home digital tests
intraclass correlation coefficient
Time frame
baseline, day 1, day 89, day 903
To assess test-retest reliability of at-home digital tests
intraclass correlation coefficient mean k raters (ICCk; k=day)
Time frame
Day1, Day 2, Day 3, Day 87, Day 88, Day 894
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score
Pearson correlation coefficient between digital composite score and QMG score
Time frame
baseline, day 1Sponsors and contacts
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Source ClinicalTrials.gov