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RECRUITING
NCT05564936
NA

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

Sponsor: Ad scientiam

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-01-24

Completion Date

2026-09-24

Last Updated

2025-04-11

Healthy Volunteers

Yes

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.

Locations (19)

University of Colorado Denver

Aurora, Colorado, United States

University of Florida Health

Jacksonville, Florida, United States

HealthParterns Institute

Bloomington, Indiana, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Neurological Associates of Long Island, P.C.

Lake Success, New York, United States

Duke University

Durham, North Carolina, United States

OHSU

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

The University of Tennessee Medical Center

Knoxville, Tennessee, United States

Vanderbilt Health

Nashville, Tennessee, United States

Hôpital Raymond Poincaré

Garches, France

CHU Grenoble

Grenoble, France

Hôpital Salengro

Lille, France

CHRU Nancy

Nancy, France

CHU Nantes

Nantes, France

Pitié-Salpêtrière

Paris, France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

CHU Toulouse

Toulouse, France