Feasibility of Remote Monitoring of Patients With Myasthenia Gravis (ROME-MG)

August 21, 2026 updated by: George Washington University

Pilot Study: Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating weakness, which can worsen suddenly without a clear predictor. The hypothesis is that continuous monitoring of key aspects of patient physiology and activity coupled to rigorous telemedicine-performed examination has the potential to detect MG worsening which requires change in treatment with the benefit of avoiding need for hospitalization or emergent therapy. This study is to evaluate the reliability of the technology and patient compliance to the monitoring program

Study Overview

Status

Recruiting

Conditions

Myasthenia Gravis (MG)

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Recruiting
    - The George Washington University
    - Contact:
      
      Gulsen Oztosun, M.D.
      
      Phone Number: 202-677-6109
      
      Email: gulsen.oztosun@gwu.edu
    - Principal Investigator:
      
      Henry J Kaminski, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Myasthenia Gravis Patients who satisfy the study's eligibility criteria

Description

Inclusion Criteria:

Subject

Has the capacity to understand and sign an informed consent form
≥18 years old
Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single fiber electromyography (EMG) or positive edrophonium test
Subject has been previously evaluated in a face-to-face clinical encounter at participating study site or referral site within the prior 3 years
Primary language is English, or equivalent level of English language fluency
Required disease severity range previously judged by the Investigator. MGFA class 1-4a within 3 years of diagnosis without other chronic medical conditions, which compromise participation.
Having MG-ADL score above 2 upon entrance to study
Patients considered by study PI not to require hospitalization at time of entrance
The patient has internet capability and a smart phone compatible with the apps required by the study.

Exclusion Criteria:

Disease Specific Exclusion Criteria

Inability to comply with study protocol for monitoring
Current MGFA Severity Class IVb or V, or patients in remission with MGFA Class 0
Any significant medical/psychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance
Any disorder that could limit ability to assess myasthenia gravis specific deficits (not including planned or recent thymectomy)
Pregnancy, based on the evaluator's judgment, if the subject is deemed not safe to undergo evaluation or comply with study visit requirements.
Lack of effective internet connection or ability to use study telemedicine station and monitors
Home environment prevents use of study equipment
Likelihood of leaving DC, Maryland, or Virginia area in year after initiation of study
Subject is already participating in a research study -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Study Completion Time Frame: 12 months	Proportion of subjects complete the 12-month study	12 months
Datasets retrieved from study assessments Time Frame: 12 months	Proportion of assessments provide data sets that can be analyzed	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction Time Frame: 12 months	Proportion of subjects indicate satisfaction with outcome measure assessment	12 months
MG-ADL and MG-CE Time Frame: 12 months	Correlation of MG-CE individual assessments to MG-ADL assessments	12 months
Fitbit correlation Time Frame: 12 months	Correlation of Fitbit metrics to MG-ADL and MG-CE	12 months
Hospital Anxiety and Depression Scale Time Frame: 12 months	Utilizing HADS questionnaire	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Garbey M, Lesport Q, Girma H, Oztosun G, Abu-Rub M, Guidon AC, Juel V, Nowak RJ, Soliven B, Aban I, Kaminski HJ. Application of digital tools and artificial intelligence in the Myasthenia Gravis Core Examination. Front Neurol. 2024 Dec 4;15:1474884. doi: 10.3389/fneur.2024.1474884. eCollection 2024.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)