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ClinicalTrials.gov ID

NCT05564936

Lead Sponsor

Ad scientiamOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

144Estimated

Last Update Posted

Apr 11, 2025Actual

Start Date

Jan 24, 2024Actual

Primary Completion Date

Sep 24, 2025Estimated

Completion Date

Sep 24, 2026Estimated

Official Title

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

Brief 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.

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 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

• ME&MG mobile application

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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.

Primary Purpose

Other

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Ad scientiamOTHER

Yann.Pereon@univ-nantes.fr+33 0240083617

cintas.p@chu-toulouse.fr+33 5 61 77 94 40