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

Ad scientiam · NCT05564936

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
144
US sites recruiting
9
Study start
January 24, 2024
Record last updated
April 11, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: ME&MG mobile application

Conditions: Myasthenia Gravis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Colorado Denver

    Aurora, CO 80204

    Site contact: Thomas Ragole, Dr · 303-724-2188 · thomas.ragole@cuanschutz.edu

  • University of Florida Health

    Jacksonville, FL 32209

    Site contact: Michael T Pulley · (904) 383-1022 · michael.pulley@jax.ufl.edu

  • Indiana University Health

    Indianapolis, IN 46123

    Site contact: Sara M Takacs · 3179485450 · stakacs@iuhealth.org

  • University of Kentucky

    Lexington, KY 40536

    Site contact: Ima M Ebong · 8592571000 · Ima.Ebong@uky.edu

  • Neurological Associates of Long Island, P.C.

    Lake Success, NY 11042

    Site contact: Denis Ostrovskiy, MD · (516) 466-4700 · dostrovskiy@neuroli.com

  • Duke University

    Durham, NC 27708

    Site contact: Shruti Raja, Dr · 919-684-5422 · shruti.raja@duke.edu

  • OHSU

    Portland, OR 97239

    Site contact: Nizar Chahin, Dr · 503-494-7772 · chahin@ohsu.edu

  • Thomas Jefferson University

    Philadelphia, PA 19144

    Site contact: Erika Wong, Dr · 215 955-4672 · Ericka.Wong@jefferson.edu

  • Vanderbilt Health

    Nashville, TN 37232

    Site contact: Lindsay Malatesta, Dr · 615 936-0600 · lindsay.malatesta@vumc.org

Study contacts (from the official record)

  • Pr Laforet · +33147107752 · pascal.laforet@aphp.fr
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia… (NCT05564936) | Bored Studies