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

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ClinicalTrials.gov Identifier: NCT05564936

Recruitment Status : Recruiting

First Posted : October 4, 2022

Last Update Posted : April 24, 2024

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Sponsor:

Information provided by (Responsible Party):

Ad scientiam

Tracking Information

First Submitted Date ^ICMJE

September 27, 2022

First Posted Date ^ICMJE

October 4, 2022

Last Update Posted Date

April 24, 2024

Actual Study Start Date ^ICMJE

January 24, 2024

Estimated Primary Completion Date

March 15, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

To compare results between in-clinic digital tests and in-clinic standard tests, test to test [ Time Frame: baseline ]
pearson correlation coefficient between digital tests and standard tests
To assess reproducibility between in-clinic digital tests and at-home digital tests [ Time Frame: baseline, day 1, day 89, day 90 ]
intraclass correlation coefficient
To assess test-retest reliability of at-home digital tests [ Time Frame: Day1, Day 2, Day 3, Day 87, Day 88, Day 89 ]
intraclass correlation coefficient mean k raters (ICCk; k=day)
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 ]
Pearson correlation coefficient between digital composite score and QMG score
To assess adverse events related to the use of the mobile application [ Time Frame: through study completion, an average of 1 year ]
Descriptive analysis of adverse events (AEs) related to the use of the application
To assess satisfaction and user experience with the smartphone application [ Time Frame: through study completion, an average of 1 year ]
descriptive analysis of questionnaires resulsts
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 ]
Pearson's correlation coefficient between ME&MG composite score and MG-ADL scores
to assess daily activites [ Time Frame: 12 months ]
Myasthenia Gravis Activities of Daily Living (MG-ADL)
to assess depression [ Time Frame: 12 months ]
Patient Health Questionnaire-8 (PHQ8)
to assess pain [ Time Frame: 12 months ]
pain likert scale
to assess insomnia [ Time Frame: 12 months ]
Insomnia Severity Index
To assess at-home compliance to the ME&MG smartphone application [ Time Frame: through study completion, an average of 1 year ]
descriptive analysis of adherence data
To assess quality of life [ Time Frame: Baseline, day 90, Day 365 ]
36-Item Short Form Survey (SF-36)

Original Secondary Outcome Measures ^ICMJE

To compare results between in-clinic digital tests and in-clinic standard tests, test to test [ Time Frame: baseline ]
pearson correlation coefficient between digital tests and standard tests
To assess reproducibility between in-clinic digital tests and at-home digital tests [ Time Frame: baseline, day 1, day 89, day 90 ]
intraclass correlation coefficient
To assess test-retest reliability of at-home digital tests [ Time Frame: Day1, Day 2, Day 3, Day 87, Day 88, Day 89 ]
intraclass correlation coefficient mean k raters (ICCk; k=day)
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 ]
Pearson correlation coefficient between digital composite score and QMG score
To assess adverse events related to the use of the mobile application [ Time Frame: through study completion, an average of 1 year ]
Descriptive analysis of adverse events (AEs) related to the use of the application
To assess satisfaction and user experience with the smartphone application [ Time Frame: through study completion, an average of 1 year ]
descriptive analysis of questionnaires resulsts
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 ]
Pearson's correlation coefficient between ME&MG composite score and MG-ADL scores
to assess daily activites [ Time Frame: 3 months ]
Myasthenia Gravis Activities of Daily Living (MG-ADL)
to assess depression [ Time Frame: 3 months ]
Patient Health Questionnaire-8 (PHQ8)
to assess pain [ Time Frame: 3 months ]
pain likert scale
to assess insomnia [ Time Frame: 3 months ]
Insomnia Severity Index
To assess at-home compliance to the ME&MG smartphone application [ Time Frame: through study completion, an average of 1 year ]
descriptive analysis of adherence data
To assess quality of life [ Time Frame: Baseline, day 90 ]
36-Item Short Form Survey (SF-36)

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other

Condition ^ICMJE

Myasthenia Gravis

Intervention ^ICMJE

Device: ME&MG mobile application

Study Arms ^ICMJE

Experimental: MG patients
MG patients will perform 3 in-clinic visits and use the ME&MG app at-home during 12 months

Intervention: Device: ME&MG mobile application
Healthy volunteers
Healthy volunteers will perform one in-clinic visit and will use the app at-home once

Intervention: Device: ME&MG mobile application

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

144

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

September 15, 2025

Estimated Primary Completion Date

March 15, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 Years to 60 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
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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Listed Location Countries ^ICMJE

France, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05564936

Other Study ID Numbers ^ICMJE

DOMYA

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Device Product Not Approved or Cleared by U.S. FDA:	Yes

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Ad scientiam

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Ad scientiam

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Ad scientiam

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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