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NCT05564936Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
144 (estimated)
First submitted
27 Sept 2022
Start date
24 Jan 2024
Primary completion date
24 Sept 2025
Lead sponsor
Ad scientiam
NCT number
NCT05564936

What you commit to

  • Study type: Interventional
  • Planned participants: 144
  • From 24 Jan 2024 to the primary completion date, 24 Sept 2025
  • 19 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
  • 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.

Other illness

  • 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.

Other

  • Pregnant and nursing women
  • Person under guardianship or curatorship
  • Participant included in another ME\&MG clinical study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Raymond-Poincaré
Coordinator of this site? Confirm its status
GarchesFranceRecruiting
Chu Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceNot yet recruiting
Hôpital Salengro
Coordinator of this site? Confirm its status
LilleFranceRecruiting
CHRU Nancy
Coordinator of this site? Confirm its status
NancyFranceRecruiting
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Pitié-Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU de Strasbourg Hôpital de Hautepierre
Coordinator of this site? Confirm its status
StrasbourgFranceCompleted
CHU Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
University of Colorado Denver
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
HealthParterns Institute
Coordinator of this site? Confirm its status
BloomingtonUnited StatesCompleted
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Indiana University Health
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of Florida Health
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
The University of Tennessee Medical Center
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesNot yet recruiting
Neurological Associates of Long Island, P.C.
Coordinator of this site? Confirm its status
Lake SuccessUnited StatesRecruiting
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Vanderbilt Health
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Thomas Jefferson University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
OHSU
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.