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Behavioural Intervention

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: MG patientsExperimental Treatment1 Intervention

MG patients will perform 3 in-clinic visits and use the ME&MG app at-home during 12 months

Group II: Healthy volunteersExperimental Treatment1 Intervention

Healthy volunteers will perform one in-clinic visit and will use the app at-home once

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Ad scientiamLead Sponsor

10 Previous Clinical Trials

1,400 Total Patients Enrolled

1 Trials studying Myasthenia Gravis

500 Patients Enrolled for Myasthenia Gravis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial admit participants who are below retirement age?

"This medical trial has an upper age limit of 60 years old and requires all participants to be above the legal age of majority."

Answered by AI

Is there still an opportunity to join this clinical experiment?

"Clinicaltrials.gov reports that this medical trial, which had its first listing on October 30th 2023 and was last updated 19 days later, is not presently taking patients onboard for participation. However there are 88 other studies actively recruiting participants at the present juncture."

Answered by AI

What criteria must a person meet to participate in this clinical research?

"This clinical trial seeks 144 myasthenia gravis patients aged 18 to 60. In addition, the following conditions must be met: possessing an anti-AChR autoantibody; agreeing to the information sheet and signing a consent form; owning a smartphone running software version 13 (iOS) or 8 (Android) or higher; being able to read either French, English, or Spanish language as well as comprehending pictograms."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

2024. "The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05564936.

All > Myasthenia Gravis