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Abstract Details

ME&MG, Novel Digital Device for Patients with Generalized Myasthenia Gravis: A First Step Towards Validation
Neuromuscular and Clinical Neurophysiology (EMG)
P1 - Poster Session 1 (8:00 AM-9:00 AM)
11-016
To describe usability validation results and subsequent investigational study designed to validate the clinical performance of a novel smartphone-based device intended for patients with generalized myasthenia gravis (gMG).

gMG is an antibody-mediated autoimmune disease that causes weakness of the bulbar, ocular, and skeletal limb muscles. Its fluctuating symptoms hamper adequate monitoring for patients and clinicians.

To address this challenge, ME&MGTM, a Software as a Medical Device, was developed to enable patients to self-monitor in their daily environment by collecting objective digital biomarkers on main gMG symptoms (ptosis, dysarthria, respiratory capacity, upper and lower limb weakness), while communicating the results to clinicians.

26 gMG patients were recruited from the USA and France to participate in a 90-minute evaluation following usability engineering methods to validate the ME&MGTM interface (mobile application).

The DOMYA clinical investigation, a prospective, low-interventional, open-label, international study (USA, France), was designed to validate the clinical performance and safety of ME&MGTM. It will enroll 94 gMG adult patients with positive anti-acetylcholine receptor antibodies. The primary objective will measure the association between ME&MGTM scores measured at home, with Quantitative Myasthenia Gravis (QMG) corresponding subscores measured in the clinic using a minimum significant correlation coefficient of 0.65. Secondary objectives will confirm analytical performance, adherence and safety.

ME&MGTM was perceived as very easy to use (mean=9.2/10, standard deviation (SD)=0.90) with a success rate of over 96% for each tested feature.

After a study duration of 30 months, final results of the DOMYA study will be analyzed and made available in 2025.

Through this usability validation evaluation, we demonstrated that ME&MGTM is a safe and usable device. 

The DOMYA clinical study aims to demonstrate ME&MGTM clinical performance, enabling its registration as a medical device in Europe and the USA.
Authors/Disclosures
Clarissa Gorin, Other (Ad Scientiam)
PRESENTER 		Dr. Gorin has received personal compensation for serving as an employee of Ad Scientiam.
Edouard Berling Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LFB.
David Orlikowski, MD (Hospital R Poincare) Dr. Orlikowski has nothing to disclose.
Guillaume Nicolas (AP-HP) Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson & Johnson. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson.
Helene Prigent (Hopital Raymond Poincaré - APHP) Helene Prigent has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Amicus therapeutics SAS. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lowenstein Medical. Helene Prigent has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SOS Oxygen. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ASV Santé- Oxylis.
Ghislain N'Dah-Sekou No disclosure on file
Loic Carment (Ad Scientiam) Loic Carment has received personal compensation for serving as an employee of Ad Scientiam.
Lissandra Klaeylé (Ad Scientiam) Lissandra Klaeylé has received personal compensation for serving as an employee of Ad Scientiam.
Dellini Ravindra (Ad Scientiam) Dellini Ravindra has received personal compensation for serving as an employee of Ad Scientiam.
Emma Touré Cuq (Ad Scientiam) No disclosure on file
Alizé Vives (Ad Scientiam) No disclosure on file
Martin Keller (Alexion GmbH) No disclosure on file
Emrah Aras (Alexion Pharmaceuticals Inc.) No disclosure on file
Saad Zinai Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Pascal Lafort Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ALEXION. The institution of Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ARGENX. Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for JOHNSON and JOHNSON. Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Revue Neurologique.