Clinical trial · Observational
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lambert-Eaton Myasthenic Syndrome | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Myasthenic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Increased multimodal observation including digital monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Myasthenic Syndromes Observational Cohort
- description
- Cohort to be characterized via clinical, serological and digital observations
- interventionNames
- Other: Increased multimodal observation including digital monitoring
Primary outcomes (5)
- measure
- QMG: Quantitative Myasthenia Gravis Scale
- timeFrame
- 6 months, monthly
- description
- The QMG-Score is a clinical tool to assess the severity of symptoms in MG. It evaluates muscle strength and function in specific muscle groups (ocular, oral, facial, neck and limb muscles), grip strength and vital capacity. It ranges from 0 to 39, with higher scores indicating an increased symptom load.
- measure
- MGC: Myasthenia Gravis Composite
- timeFrame
- Baseline, after 3 and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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)
References
Publications (0)
Data not yet available