RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-01-24

Study Completion:2025-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05564936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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

Study Locations (Sites)

University of Florida Health

Jacksonville, Florida, 32209

United States

Indiana University Health

Indianapolis, Indiana, 46123

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

Neurological Associates of Long Island, P.C.

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Ad scientiam

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24

Study Completion Date2025-09-15

Study Record Updates

Study Start Date2024-01-24

Study Completion Date2025-09-15

Terms related to this study

Additional Relevant MeSH Terms

Myasthenia Gravis