RECRUITINGOBSERVATIONAL
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
About This Trial
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.
Who May Be Eligible (Plain English)
* 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 willing to sign a consent form, based on investigator´s judgment
Who Should NOT Join This Trial:
Patients who meet any of the following criteria will be excluded from participation:
- Unable or unwilling to give willing to sign a consent form
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
* 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)
Treatments Being Tested
OTHER
Increased multimodal observation including digital monitoring
Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers
Locations (1)
Heinrich-Heine University, Duesseldorf
Düsseldorf, Germany