Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis (POWER-MG)

Heinrich-Heine University, Duesseldorf

Status

Enrolling

Conditions

Myasthenia Gravis

Myasthenic Syndrome

Lambert-Eaton Myasthenic Syndrome

Treatments

Other: Increased multimodal observation including digital monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT06441825

MPGv1.0

Details and patient eligibility

About

This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical scores and various questionnaires including sores on quality of life, sleep quality or activities of daily living. Primarily including patients treated with newly approved drugs, it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment.

Full description

Myasthenia Gravis (MG) is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction. Typically, symptomatic assessments occur during clinical encounters, either as part of routine treatment assessments or in acute situations such as myasthenic crises. However, for a comprehensive understanding of mechanisms in MG and disease activity, continuous monitoring is essential.

Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures, clinical scores such as the QMG scale and MGC, as well as various questionnaires addressing sleep quality, quality of life or activities of daily living.

Data recorded by the used wearables (Withings Scanwatch 2) cover various parameters including activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep quality, etc.).

Prospectively, this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments, particularly of the newly approved drugs for MG.

In the future, wearables might hold the potential to improve treatment processes and optimize therapeutic approaches. For instance, digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena, paving the way for personalized treatment strategies tailored to individual patient needs.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Formal diagnosis of generalized Myasthenia Gravis, with at least one of the following criteria:
- Response to oral or intravenous administration of an acetylcholinesterase inhibitor
- Evidence of pathological decrement/ elevated jitter
- Evidence of Myasthenia Gravis-typical antibody (AChR, LRP4, MuSK, Titin) OR other diagnosed Myasthenic Syndrome
Age ≥ 18
Usage of Smartphone with Android 8.1 (or higher) or IOS12.3 (or higher)
Able to provide informed consent, based on investigator´s judgment

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from participation:

Unable or unwilling to give informed consent
Unable or unwilling to use the smartphone app
Any significant comorbidity that might potentially interfere with the ability to successfully participate in the study, based on investigator´s judgment
Patient with exclusively ocular symptoms (ocular myasthenia gravis)