Digital Monitoring App for Myasthenia Gravis

Recruiting at 16 trial locations

Overseen By Pr Laforet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Disqualifiers: Thymectomy, Plasma Exchange, Immunoglobulin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called the ME&MG Digital Solution, designed to help people with myasthenia gravis (MG) track their symptoms at home. The app monitors issues like muscle weakness, breathing difficulties, and general well-being. Researchers will compare it to standard in-clinic tests to assess its accuracy and reliability. People with MG who experience generalized muscle weakness and use a smartphone might be suitable for this study. The trial also evaluates the app's ease of use and user satisfaction. Healthy volunteers will participate briefly to provide baseline data for comparison. As an unphased trial, this study offers a unique opportunity to contribute to innovative technology that could enhance daily life for those with MG.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It seems focused on using a digital app for monitoring symptoms, so you might not need to change your medication routine, but it's best to confirm with the trial organizers.

What prior data suggests that this digital monitoring app is safe for patients with Myasthenia Gravis?

Research shows that specific safety information for the ME&MG digital monitoring app for myasthenia gravis is not yet available. However, studies generally evaluate mobile health apps like this one to ensure user safety. As a digital tool rather than a medication, the app likely poses fewer risks compared to traditional drug treatments. It is designed to help patients track symptoms and communicate with doctors. This trial focuses on assessing the app's effectiveness and usability, rather than directly examining safety issues such as medication side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ME&MG Digital Solution because it introduces a novel way to manage Myasthenia Gravis (MG) through digital monitoring. Unlike traditional treatments that focus on medications like acetylcholinesterase inhibitors and immunosuppressants, this app empowers patients by providing real-time data tracking and personalized management tools. The ME&MG app allows MG patients to engage with their health from home, potentially leading to more tailored and timely interventions. This digital approach could revolutionize how MG is managed by enhancing patient involvement and improving long-term outcomes.

What evidence suggests that this digital monitoring app is effective for Myasthenia Gravis?

Research has shown that the ME&MG digital tool helps people with myasthenia gravis (MG) monitor their symptoms at home. In this trial, MG patients will use the ME&MG app to track their condition over 12 months, performing tests for issues like drooping eyelids, breathing problems, speech difficulties, and limb weakness. Studies suggest that this app might provide results similar to traditional clinic tests. The tool also includes questions about daily activities, pain, and tiredness, aiding in tracking how MG affects patients' lives. While still under study, this tool could simplify condition management, reducing the need for frequent doctor visits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to use a smartphone

Own a personal smartphone which software version is above 13 for iOS and 8 for Android included

I can read and understand French, English, or Spanish and can understand pictograms.

Exclusion Criteria

Participant included in another ME&MG clinical study

Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study

Pregnant and nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial in-clinic assessment and baseline data collection

1 day

1 visit (in-clinic)

Treatment Follow-up

Participants use the ME&MG app at-home for self-assessment and monitoring of symptoms

12 months

3 visits (in-clinic) for MG patients, 1 visit (in-clinic) for healthy volunteers

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ME&MG Digital Solution

Trial Overview 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.

How Is the Trial Designed?

Group I: MG patients Experimental Treatment 1 Intervention

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

Group II: Healthy volunteers Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Published Research Related to This Trial

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

The European Academy of Allergy and Clinical Immunology's task force reviewed the potential of mobile health (mHealth) technologies to enhance patient care in allergology, emphasizing their role in supporting self-management and improving health services for allergic diseases.

The task force highlighted the importance of user engagement, design, and privacy policies in mHealth products, suggesting that effective mHealth solutions could shift the focus from clinician-centered to patient-centered care in managing allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of mobile health technologies in allergy care: An EAACI position paper. Matricardi, PM., Dramburg, S., Alvarez-Perea, A., et al.[2021]

The MG-ADL profile, a patient-reported scale for myasthenia gravis, shows strong correlations with established measures like the Quantitative MG score and the MG Composite, indicating its effectiveness in assessing symptoms and their impact on daily activities.

A 2-point improvement on the MG-ADL scale is a reliable indicator of clinical improvement, making it a valuable tool for both clinical management and as a secondary outcome measure in trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The myasthenia gravis--specific activities of daily living profile. Muppidi, S.[2019]

A review of 138 incident reports from users of electronic health records in Finland revealed that vulnerabilities in these systems can lead to serious harm across various healthcare settings.

The low rate of reported incidents suggests significant challenges in the oversight of medical software and highlights potential barriers to effective reporting of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. Palojoki, S., Saranto, K., Lehtonen, L.[2020]

An expert panel developed a comprehensive application for myasthenia gravis (MG) management, which includes features like medication tracking, symptom recording, and alerts for healthcare providers, aimed at improving patient care and safety.

Neurologists rated the application's usability highly (average score of 8.23 out of 9), indicating strong support for its potential to enhance patient quality of life and healthcare efficiency in managing MG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability monitoring of patients with myasthenia gravis using a mobile-based application. Alaei Tafti, E., Ghazisaeedi, M., Sarraf, P.[2023]

The COVID-19 pandemic has necessitated a shift in healthcare delivery for patients with chronic neurological diseases like myasthenia gravis (MG), highlighting the need for early detection of disease worsening and complications.

The study proposes an online evaluation protocol using four simple tests, leveraging telemedicine and digital technology to enhance MG management and reduce the need for in-person consultations during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myasthenia gravis and telemedicine: a lesson from COVID-19 pandemic. Ricciardi, D., Casagrande, S., Iodice, F., et al.[2022]

A survey of 480 patients and 31 general practitioners (GPs) revealed that while 56% of patients and 42% of GPs were willing to use mobile health (mHealth) applications for reporting adverse drug reactions (ADRs), willingness decreased with age for both groups.

Patients valued rapid feedback on consultation urgency, while GPs preferred information on medication administration difficulties; however, barriers included older patients' preference for personal contact with their GP and GPs' concerns about time and resource demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. Wakob, I., Schmid, GL., Nöhring, I., et al.[2022]

A group of experts has established consensus recommendations to standardize outcome measures in clinical trials for myasthenia gravis (MG), addressing variability that can affect trial data reliability.

Key changes were made to several assessment tools, including the MG-Activities of Daily Living and the Quantitative MG (QMG) score, to improve clarity and consistency in their administration, with further validation studies planned for the revised QMG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Outcome Measure Variability in Myasthenia Gravis Clinical Trials. Guptill, JT., Benatar, M., Granit, V., et al.[2023]

Myasthenia gravis (MG) affects approximately 20 per 100,000 people in the U.S. and is characterized by muscle weakness and fatigue due to a defect at the neuromuscular junction.

The American Association of Neuroscience Nurses' Clinical Practice Guideline provides comprehensive evidence-based recommendations for nursing management of MG, covering aspects like diagnosis, treatment options, and the critical role of nurses in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guideline series update. Blissitt, PA.[2013]

A total of 1,711 requests for advice were analyzed from patients with Myasthenia Gravis, revealing that 47% of inquiries to the German Myasthenia Gravis Association (DMG) were related to medical issues, particularly concerning medication side effects and treatment questions.

The study highlights a significant demand for timely advice among MG patients, suggesting that implementing standardized responses and modern digital communication tools, like telemedicine, could improve the efficiency of addressing patient inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myasthenia gravis - a retrospective analysis of e-mail inquiries made to a patient organisation and specialized center to uncover unmet needs from patients and caregivers. Stein, M., Hoffmann, S., Gerischer, L., et al.[2023]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

A study involving 58 patients with myasthenia gravis (MG) identified limb weakness as the most impactful symptom, while side effects like weight gain and mood swings were the most bothersome, highlighting the need for treatments with minimal adverse effects.

The Myasthenia Gravis Quality of Life-Revised (MG-QOL15R) scale was chosen as the primary patient-centered outcome measure for the PROMISE-MG trial, emphasizing the importance of patient input in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying a patient-centered outcome measure for a comparative effectiveness treatment trial in myasthenia gravis. Narayanaswami, P., Sanders, DB., Bibeau, K., et al.[2022]

The virtual Myasthenia Gravis Impairment Index (vMGII) effectively correlates with other patient-reported outcomes, demonstrating its utility in assessing disease status during telephone consultations for 214 myasthenia gravis patients.

A vMGII score of 11.5 or higher reliably predicts a positive response on the Patient-Acceptable Symptom State (vPASS), with a sensitivity of 78.7% and specificity of 81.4%, indicating its effectiveness in monitoring disease progression even without in-person evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. Menon, D., Alnajjar, S., Barnett, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05564936

Study Details | NCT05564936 | The ME&MG Digital ... It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000204973

ME&MG, Novel Digital Device for Patients with Generalized ... The primary objective will measure the association between ME&MG™ scores measured at home, with Quantitative Myasthenia Gravis (QMG) corresponding subscores ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05566964

NCT05566964 | Descriptive Analysis of Real-world Data ... The objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, ...

4. youtube.com youtube.com/watch?v=TUSIybWeSws

Research Webinar Series: ME&MGopen, an innovative ... We want to revolutionize the way to measure and predict the evolution of severe and disabling diseases such as mg or for example also multiple sclerosis.

5. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT05564936

The ME&MG Digital Solution for Autonomous Assessment ... ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960896624008071

the DOMYA Study ME&MGTM, a Software as a Medical Device, has been developed. It allows patients to regularly monitor their gMG symptoms in their everyday environment.

7. withpower.com withpower.com/trial/phase-muscle-weakness-1-2023-8e380

Digital Monitoring App for Myasthenia Gravis There is no specific safety data available for the Digital Monitoring App for Myasthenia Gravis, but mobile health applications in general are being studied ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05564936/the-memg-digital-solution-for-autonomous-assessment-of-myasthenia-gravis

The ME&MG Digital Solution for Autonomous Assessment ... ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians.