myasthenia gravis
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: definite diagnosis of myasthenia gravis (positive serologic test or electrophysiological support or positive neostigmine test)
Exclusion criteria
Exclusion criteria: Participants with active Graves* disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diagnostic yield, expressed as sensitivity, specificity and area under the curve of a receiver-operator curve (ROC) of the FaceReader algorithm, using quantitative data of facial weakness expressed in Action Units (AU), ranging between 0 (no activation) and +1 (maximal activation). Raw data from FaceReader provides the results of 20 AU*s corresponding with 20 different facial movements of 20 facial muscles based on the Facial Action Coding System (FACS). We will calculate the diagnostic yield of individual muscles and combinations of muscles to differentiate between healthy controls and MG and between different grades of MG disease severity. 2. Diagnostic yield, expressed as sensitivity, specificity and area under the curve of a receiver-operator curve (ROC) of a working narrow deep learning model to differentiate between healthy controls and MG and between different grades of MG disease severity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Detection of medication effects by obtaining multiple videos (longitudinal) in a subset of patients. The QMG score is the parameter for change in disease severity. A previous study found a minimal clinically important difference (MCID) in QMG score of >=2 for a baseline QMG score between 0 and 16. For a baseline QMG score >16 the MCID is >=3 points change in QMG score4. For change in severity, our aim is to detect an intra-participant difference in case of a change in QMG >=2 or >=3, depending of baseline QMG score. 2. A comparison of the diagnostic yield of FaceReader parameters and classification by the deep learning model. | — |
Countries
Netherlands
Outcome results
None listed