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
- Diseases
- Myasthenia gravis
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Raymond-Poincaré Coordinator of this site? Confirm its status | Garches | France | Recruiting |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Hôpital Salengro Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHRU Nancy Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Pitié-Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU de Strasbourg Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| HealthParterns Institute Coordinator of this site? Confirm its status | Bloomington | United States | Completed |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Florida Health Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| The University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Not yet recruiting |
| Neurological Associates of Long Island, P.C. Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Vanderbilt Health Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| OHSU Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.