Recruiting NCT05564936

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

No phase Interventional Myasthenia Gravis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ME&MG mobile application.
Who it may be relevant to: Registry conditions: Myasthenia Gravis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Detailed description

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 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.

Interventions

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.

Primary outcome measures

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 [Time frame: baseline]

Secondary outcome measures (12)

To compare results between in-clinic digital tests and in-clinic standard tests, test to test [Time frame: baseline]
To assess reproducibility between in-clinic digital tests and at-home digital tests [Time frame: baseline, day 1, day 89, day 90]
To assess test-retest reliability of at-home digital tests [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 [Time frame: baseline, day 1]
To assess adverse events related to the use of the mobile application [Time frame: through study completion, an average of 1 year]
To assess satisfaction and user experience with the smartphone application [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 [Time frame: baseline, day 90, day 365]
to assess daily activites [Time frame: 12 months]
to assess depression [Time frame: 12 months]
to assess pain [Time frame: 12 months]
to assess insomnia [Time frame: 12 months]
To assess at-home compliance to the ME&MG smartphone application [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Other

Study locations

United States · 11 centers

University of Colorado Denver — Aurora
University of Florida Health — Jacksonville
HealthParterns Institute — Bloomington
Indiana University Health — Indianapolis
University of Kentucky — Lexington
Neurological Associates of Long Island, P.C. — Lake Success
Duke University — Durham
OHSU — Portland
… and 3 more centers

France · 8 centers

Hôpital Raymond Poincaré — Garches
CHU Grenoble — Grenoble
Hôpital Salengro — Lille
CHRU Nancy — Nancy
CHU Nantes — Nantes
Pitié-Salpêtrière — Paris
CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg
CHU Toulouse — Toulouse

Identifiers

NCT: NCT05564936 · DOMYA

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗