Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis (NCT06441825) | Clinical Trial Compass
UnknownNot Applicable
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
Germany20 participantsStarted 2024-05-02
Plain-language summary
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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
QMG: Quantitative Myasthenia Gravis Scale
Timeframe: 6 months, monthly
2
MGC: Myasthenia Gravis Composite
Timeframe: Baseline, after 3 and 6 months
3
MGFA-PIS: Myasthenia Gravis Post intervention status
Timeframe: Baseline, after 3 and 6 months
4
MG-ADL: Myasthenia Gravis Activities of Daily Living