An interventional study of ME&MG mobile application in Myasthenia Gravis, sponsored by Ad scientiam. Recruiting at 19 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Ad scientiam · Not applicable, Interventional, and Other
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.
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.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
This study's planned enrollment of 144 is above the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Ad scientiam is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months
Device: ME&MG mobile application
Healthy volunteers will perform one in-clinic visit and will use the app at-home once
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.
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: baseline
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: baseline
To assess reproducibility between in-clinic digital tests and at-home digital tests
intraclass correlation coefficient
Time frame: baseline, day 1, day 89, day 90
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 89
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 1
To assess adverse events related to the use of the mobile application
Descriptive analysis of adverse events (AEs) related to the use of the application
Time frame: through study completion, an average of 1 year
To assess satisfaction and user experience with the smartphone application
descriptive analysis of questionnaires resulsts
Time frame: through study completion, an average of 1 year
To assess correlation of the at-home ME&MG composite score with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Pearson's correlation coefficient between ME\&MG composite score and MG-ADL scores
Time frame: baseline, day 90, day 365
to assess daily activites
Myasthenia Gravis Activities of Daily Living (MG-ADL)
Time frame: 12 months
to assess depression
Patient Health Questionnaire-8 (PHQ8)
Time frame: 12 months
to assess pain
pain likert scale
Time frame: 12 months
to assess insomnia
Insomnia Severity Index
Time frame: 12 months
To assess at-home compliance to the ME&MG smartphone application
descriptive analysis of adherence data
Time frame: through study completion, an average of 1 year
To assess quality of life
36-Item Short Form Survey (SF-36)
Time frame: Baseline, day 90, Day 365
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Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Sep 2025, 20 months after the start.
Of 35 interventional studies with no phase under Myasthenia Gravis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
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