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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
Sponsor:
Information provided by (Responsible Party):
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Study Description
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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.


Condition or disease Intervention/treatment Phase
Myasthenia Gravis Device: ME&MG mobile application Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
Actual Study Start Date : January 24, 2024
Estimated Primary Completion Date : March 15, 2025
Estimated Study Completion Date : September 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MG patients
MG patients will perform 3 in-clinic visits and use the ME&MG app at-home during 12 months
 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.
Healthy volunteers
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.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: baseline ]
    Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. to assess daily activites [ Time Frame: 12 months ]
    Myasthenia Gravis Activities of Daily Living (MG-ADL)

  9. to assess depression [ Time Frame: 12 months ]
    Patient Health Questionnaire-8 (PHQ8)

  10. to assess pain [ Time Frame: 12 months ]
    pain likert scale

  11. to assess insomnia [ Time Frame: 12 months ]
    Insomnia Severity Index

  12. 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

  13. To assess quality of life [ Time Frame: Baseline, day 90, Day 365 ]
    36-Item Short Form Survey (SF-36)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05564936


Locations
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United States, Florida
University of Florida Health Recruiting
Jacksonville, Florida, United States, 32209
Contact: Michael T Pulley    904-383-1022    michael.pulley@jax.ufl.edu   
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46123
Contact: Sara M Takacs    317-948-5450    stakacs@iuhealth.org   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Ima M Ebong    859-257-1000    Ima.Ebong@uky.edu   
United States, New York
Neurological Associates of Long Island, P.C. Recruiting
Lake Success, New York, United States, 11042
Contact: Denis Ostrovskiy, MD    516-466-4700    dostrovskiy@neuroli.com   
France
Hôpital Raymond Poincaré Not yet recruiting
Garches, France, 92380
Contact: Pascal Laforet         
Principal Investigator: Edouard Berling         
CHRU Nancy Not yet recruiting
Nancy, France, 54035
Contact: Maud Michaud, Dr         
CHU de Strasbourg - Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67200
Contact: Aleksandra Nadaj Pakleza, Dr         
Sponsors and Collaborators
Ad scientiam
More Information
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Responsible Party: Ad scientiam
ClinicalTrials.gov Identifier: NCT05564936    
Other Study ID Numbers: DOMYA
First Posted: October 4, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases