Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05564936 | RECRUITING | Myasthenia Gravis

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

To science

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

Myasthenia Gravis

Intervention/treatment

ME&MG mobile application

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 144 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
Actual Study Start Date : 2024-01-24
Estimated Primary Completion Date : 2025-09-24
Estimated Study Completion Date : 2026-09-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

Location Details

NCT05564936

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Denver

Aurora, Colorado, United States, 80204

RECRUITING

United States, Florida

University of Florida Health

Jacksonville, florida, United States, 32209

COMPLETED

United States, Indiana

HealthParterns Institute

Bloomington, Indiana, United States, 47401

RECRUITING

United States, Indiana

Indiana University Health

Indianapolis, Indiana, United States, 46123

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

RECRUITING

United States, New York

Neurological Associates of Long Island, P.C.

Lake Success, New York, United States, 11042

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27708

RECRUITING

United States, Oregon

OHSU

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19144

NOT YET RECRUITING

United States, Tennessee

The University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Tennessee

Vanderbilt Health

Nashville, Tennessee, United States, 37232

RECRUITING

France,

Raymond Poincaré Hospital

Garches, France, 92380

NOT YET RECRUITING

France,

CHU Grenoble

Grenoble, France,

RECRUITING

France,

Salengro Hospital

Lille, France,

RECRUITING

France,

CHRU Nancy

Nancy, France, 54035

RECRUITING

France,

CHU Nantes

Nantes, France,

RECRUITING

France,

Pitié-Salpêtrière

Paris, France, 75013

COMPLETED

France,

Strasbourg University Hospital - Hautepierre Hospital

Strasbourg, France, 67200

RECRUITING

France,

HY Touluse

Toulouse, France,