Digital Monitoring App for Myasthenia Gravis

N/A

Recruiting

Research Sponsored by Ad scientiam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator

Aged 18 to 60 years

Must not have

Person under guardianship or curatorship

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a digital solution (ME&MG) for monitoring disabilities in people living with MG, to make assessments more accurate, reliable, and reproducible.

Who is the study for?

This trial is for adults aged 18-60 with Myasthenia Gravis, who have general muscle weakness but are unlikely to need a respirator. Participants must test positive for anti-AChR autoantibodies, own a compatible smartphone, and be able to use the ME&MG app in English, French or Spanish. Pregnant women, those under legal supervision, with recent substance abuse or involved in other studies that could affect this one cannot join.

What is being tested?

The ME&MG mobile application is being tested as an at-home self-assessment tool for monitoring disabilities caused by Myasthenia Gravis. The study aims to validate the app's accuracy compared to standard clinic tests and evaluate its safety and user satisfaction.

What are the potential side effects?

Since the intervention involves using a digital application rather than medication or invasive procedures, traditional side effects are not expected. However, potential issues may include discomfort from frequent device use or stress from self-monitoring symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with generalized myasthenia gravis and do not need a respirator.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under legal guardianship or curatorship.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions

Secondary study objectives

To assess adverse events related to the use of the mobile application

To assess at-home compliance to the ME&MG smartphone application

Myasthenia Gravis

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