Health TrialsbyHealthPanel

Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

ConditionMyasthenia Gravis (MG)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeorge Washington University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Myasthenia Gravis Patients who satisfy the study's eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Subject Study Completion

Proportion of subjects complete the 12-month study

Time frame
12 months
2

Datasets retrieved from study assessments

Proportion of assessments provide data sets that can be analyzed

Time frame
12 months

Secondary outcomes

1

Subject Satisfaction

Proportion of subjects indicate satisfaction with outcome measure assessment

Time frame
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

Time frame
12 months
3

Fitbit correlation

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

Time frame
12 months
4

Hospital Anxiety and Depression Scale

Utilizing Hospital Anxiety and Depression Scale questionnaire

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Washington University

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Collaborator

Source ClinicalTrials.gov
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