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Myasthenia Gravis (MG)ROME-MGNCT07787247

Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

An observational study of Myasthenia Gravis (MG), run by George Washington University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myasthenia Gravis (MG)
How many people
18 participants
Where
1 siteUnited States
Study dates
19 Aug 2026to Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Myasthenia Gravis Patients who satisfy the study's eligibility criteria

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • The George Washington University

    Washington D.C., District of Columbia, 20037

    Gulsen Oztosun, M.D., 202-677-6109, romemgstudy@gwu.edu

    Henry J Kaminski, M.D.

    Recruiting

Other trials in United States

About this study

Official title: 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

Keywords
telemedicine, myasthenia gravis, remote monitoring, feasibility study
Medical subject headings
Myasthenia Gravis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject Study Completion

    Proportion of subjects complete the 12-month study

    Measured: 12 months

  2. Datasets retrieved from study assessments

    Proportion of assessments provide data sets that can be analyzed

    Measured: 12 months

Secondary outcomes (4)

  1. Subject Satisfaction

    Proportion of subjects indicate satisfaction with outcome measure assessment

    Measured: 12 months

  2. Myasthenia Gravis-Activities of Daily Living and Myasthenia Gravis-Core Examination

    Correlation of Myasthenia Gravis-Core Examination individual assessments to Myasthenia Gravis-Activities of Daily Living assessments

    Measured: 12 months

  3. Fitbit correlation

    Correlation of Fitbit metrics to MG-ADL and MG-CE

    Measured: 12 months

  4. Hospital Anxiety and Depression Scale

    Utilizing Hospital Anxiety and Depression Scale questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start19 Aug 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07787247
Sponsor's protocol ID
MS056805_0001
Other IDs
51550-1-EENS9212, NCR267243, 100
Acronym
ROME-MG
Status last verified
Oct 2026
First submitted
17 Aug 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 39697445

Questions about this trial

What is this clinical trial studying?

An observational study of Myasthenia Gravis (MG), run by George Washington University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Study Completion (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07787247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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