Digital self-assessment tool for monitoring Myasthenia Gravis
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
This study is testing a new mobile app that helps people with Myasthenia Gravis track their symptoms and daily activities to see if it works as well as regular doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ad scientiam Academic / other |
| Locations | 19 sites (Aurora, Colorado and 18 other locations) |
| Trial ID | NCT05564936 on ClinicalTrials.gov |
What this trial studies
The ME&MG digital solution is a mobile application designed for patients with Myasthenia Gravis (MG) to perform unsupervised self-assessments of their symptoms. It includes digital tests for various physical functions and validated questionnaires to monitor daily activities, pain, fatigue, and mental health. The study aims to validate the accuracy and reliability of this tool compared to traditional in-clinic assessments, while also evaluating its safety and user satisfaction. By leveraging technology, the study seeks to improve the management of MG and enhance patient engagement in their own care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with generalized Myasthenia Gravis and able to use a smartphone.
Not a fit: Patients who have recently undergone specific treatments like thymectomy or plasma exchange therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could provide patients with a convenient and effective way to monitor their condition and communicate their status to healthcare providers.
How similar studies have performed: Other studies have shown promise in using digital tools for patient self-assessment, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
Where this trial is running
Aurora, Colorado and 18 other locations
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- University of Florida Health — Jacksonville, Florida, United States (Recruiting)
- HealthParterns Institute — Bloomington, Indiana, United States (Completed)
- Indiana University Health — Indianapolis, Indiana, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Neurological Associates of Long Island, P.C. — Lake Success, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Ohsu — Portland, Oregon, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- The University of Tennessee Medical Center — Knoxville, Tennessee, United States (Not_yet_recruiting)
- Vanderbilt Health — Nashville, Tennessee, United States (Recruiting)
- Hôpital Raymond Poincaré — Garches, France (Recruiting)
- CHU Grenoble — Grenoble, France (Not_yet_recruiting)
- Hôpital Salengro — Lille, France (Recruiting)
- CHRU Nancy — Nancy, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Pitié-Salpêtrière — Paris, France (Recruiting)
- CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg, France (Completed)
- CHU Toulouse — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Pr Laforet
- Email: pascal.laforet@aphp.fr
- Phone: +33147107752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.