🏛️ Verified NIH Record • Updated 2025-04-08

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis (NCT05564936)

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

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Ad scientiam

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Colorado Denver — Aurora, Colorado

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (19 Sites)

  • University of Colorado Denver — Aurora, Colorado
  • University of Florida Health — Jacksonville, Florida
  • HealthParterns Institute — Bloomington, Indiana
  • Indiana University Health — Indianapolis, Indiana
  • University of Kentucky — Lexington, Kentucky
  • Neurological Associates of Long Island, P.C. — Lake Success, New York
  • Duke University — Durham, North Carolina
  • OHSU — Portland, Oregon
  • Thomas Jefferson University — Philadelphia, Pennsylvania
  • The University of Tennessee Medical Center — Knoxville, Tennessee
  • Vanderbilt Health — Nashville, Tennessee
  • Hôpital Raymond Poincaré — Garches,
  • CHU Grenoble — Grenoble,
  • Hôpital Salengro — Lille,
  • CHRU Nancy — Nancy,
  • CHU Nantes — Nantes,
  • Pitié-Salpêtrière — Paris,
  • CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg,
  • CHU Toulouse — Toulouse,

📞 Contact the Study Coordinator

Phone: +33147107752

Email: pascal.laforet@aphp.fr

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗