BioDigit MG: A Pilot Study Examining a Digital Technology for Quantitative Assessment and Remote Monitoring of Myasthenia Gravis (P7-8.005)

Abstract

<h3>Objective:</h3> To develop a standardized, clinically-validated digital solution for rigorous, longitudinal assessment of ocular weakness and dysarthria in myasthenia gravis (MG), which can be applied remotely. <h3>Background:</h3> MG is a chronic autoimmune neuromuscular disease characterized by fluctuating weakness of skeletal muscle, which frequent affects ocular muscles and speech. Current assessments of myasthenic weakness require neurologic expertise, are time-consuming and can still be subjective. Additionally, measured at one point in time, assessments provide a snapshot of a patient’s MG, which may not adequately reflect the spectrum of fluctuating weakness. Ratings of ocular weakness and dysarthria are particularly subjective. These shortcomings of current outcome measures limit performance of clinical trials and provide a limited view of the patient’s clinical status. <h3>Design/Methods:</h3> We developed a tablet-based digital health solution that captures video data collected by patients and MG-specific patient-reported outcome measures. Ptosis and dysarthria are rated asynchronously. The tablet provides text instruction and audio prompts to the patient and data are uploaded to a cloud. Predetermined measures of success have been defined. <h3>Results:</h3> A pilot study with a target sample size of 20 individuals with MG is ongoing to determine the feasibility of using the proposed solution as a health monitoring platform for MG. Two MG experts will rate speech and video data for dysarthria and ptosis based on the Quantitative Myasthenia Gravis (QMG) scale. Association between the extracted speech and facial characteristics to clinical scores of dysarthria and ptosis will be investigated. <h3>Conclusions:</h3> Despite considerable recent advances in treatments for MG, rigorous, longitudinal tools for monitoring of its characteristic fluctuating weakness remain limited and represent an unmet need. The feasibility, validity and acceptability of the proposed digital solution will be determined for 20 patients with MG. If successful, this technology will be further developed and studied in a larger observational study. <b>Disclosure:</b> An immediate family member of Dr. Guidon has received personal compensation for serving as an employee of GE Healthcare. Dr. Guidon has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Guidon has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Momenta. Dr. Guidon has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Guidon has received research support from MGFA. The institution of Dr. Guidon has received research support from Project Data Sphere. The institution of Dr. Guidon has received research support from MGNet. The institution of Dr. Guidon has received research support from MGNet. Dr. Guidon has received publishing royalties from a publication relating to health care. Dr. Mishra has received personal compensation for serving as an employee of Biosensics. Miss Lindsay has nothing to disclose. Mr. Mulukutla has received personal compensation for serving as an employee of BioSensics LLC. Dr. Vaziri has received personal compensation for serving as an employee of Biosensics.