Actively Recruiting
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Led by Ad scientiam · Updated on 2025-04-11
144
Participants Needed
19
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years
- Diagnosed with generalized myasthenia gravis meeting MGFA Clinical Classification Class II, III, or IV
- Positive test for anti-AChR autoantibody at screening
- Have read the information sheet and signed informed consent
- Own a personal smartphone with software version above 13 (iOS) or 8 (Android)
- Able to use a smartphone
- Able to read and understand French, English, or Spanish and pictograms on the app
You will not qualify if you...
- Underwent thymectomy, plasma exchange therapy, or intravenous immunoglobulin therapy within 4 weeks before screening
- Started FcRn inhibitor therapy within 4 weeks before screening
- Medical or psychological conditions or risks that may interfere with study participation or outcomes, as judged by investigator
- Pregnant or nursing women
- Under guardianship or curatorship
- Current drug or alcohol abuse affecting test performance, as judged by investigator
- Participating in another ME&MG clinical study
- Participated in another clinical study within 30 days before screening or currently in a study that may affect participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Colorado Denver
Aurora, Colorado, United States, 80204
Actively Recruiting
2
University of Florida Health
Jacksonville, Florida, United States, 32209
Actively Recruiting
3
HealthParterns Institute
Bloomington, Indiana, United States, 47401
Completed
4
Indiana University Health
Indianapolis, Indiana, United States, 46123
Actively Recruiting
5
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
6
Neurological Associates of Long Island, P.C.
Lake Success, New York, United States, 11042
Actively Recruiting
7
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
8
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
9
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19144
Actively Recruiting
10
The University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Not Yet Recruiting
11
Vanderbilt Health
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
Hôpital Raymond Poincaré
Garches, France, 92380
Actively Recruiting
13
CHU Grenoble
Grenoble, France
Not Yet Recruiting
14
Hôpital Salengro
Lille, France
Actively Recruiting
15
CHRU Nancy
Nancy, France, 54035
Actively Recruiting
16
CHU Nantes
Nantes, France
Actively Recruiting
17
Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
18
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67200
Completed
19
CHU Toulouse
Toulouse, France
Actively Recruiting
Research Team
P
Pr Laforet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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