NCT07787247

Brief 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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
26mo left

Started Aug 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Aug 2026Oct 2028

First Submitted

Initial submission to the registry

August 17, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

August 17, 2026

Last Update Submit

August 21, 2026

Conditions

Myasthenia Gravis (MG)

Keywords

telemedicinemyasthenia gravisremote monitoringfeasibility study

Outcome Measures

Primary Outcomes (2)

  • Subject Study Completion

    Proportion of subjects complete the 12-month study

    12 months

  • Datasets retrieved from study assessments

    Proportion of assessments provide data sets that can be analyzed

    12 months

Secondary Outcomes (4)

  • Subject Satisfaction

    12 months

  • MG-ADL and MG-CE

    12 months

  • Fitbit correlation

    12 months

  • Hospital Anxiety and Depression Scale

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Myasthenia Gravis Patients who satisfy the study's eligibility criteria

You may qualify if:

  • 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.

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39697445BACKGROUND

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 26, 2026

Study Start

August 19, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations

US(1)