Myasthenia, Myasthenia gravis Myasthenia
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age >= 18 years - Ability to understand the requirements of the study and provide written informed consent. Inclusion criteria for MG participants only - A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category “definite” or “probable” MG). - MGFA Clinical Classification of disease severity I-IV. - Subjects have at least one of the symptoms of interest (namely dysarthria, dysphonia, proximal arm fatigue and/or ptosis). Inclusion criteria for non-MG participants only - Subjects are not diagnosed with and have no clinical suspicion of MG. - Subjects do not have a medical history of any of the symptoms of interest (namely dysarthria, dysphonia, proximal arm fatigue and/or ptosis).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Not willing to be audio-recorded for the study assessments. - Not willing to be video-recorded for the study assessments. - Subjects currently taking part in a clinical trial of an Investigational Medicinal Product. - Subjects who have used an immediate release pyridostigmine-based medication in the 12 hours prior to their participation and participants on prolonged release pyridostigmine, with the exception of pyridostigmine use deemed clinically necessary by the investigator. - Subjects have cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to complete study procedures. Exclusion criteria for MG participants only - Subjects with an upper-limb amputation or who are non-verbal. - Subjects with a diagnosed neurological disease resulting in muscle weakness, other than MG. Exclusion criterion for non-MG participants only - Limitation of upper limb mobility or speech impairment of any cause.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to explore whether digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis can differentiate between participants with and without MG. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) To assess the correlation between digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients and disease severity as measured by the MGC score. b) To assess the correlation between digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients and their quality-of-life as measured by the MG-ADL questionnaire. c) To assess the performance of automated signal processing of speech recordings collected through smartphone microphone for detection of dysarthria and dysphonia, in comparison to assessment by accredited clinicians. d) To assess the performance of automated measurement of proximal arm-fatiguing exercises through computer vision techniques applied to smartphone camera recordings for detection of proximal arm muscle weakness and fatigability, in comparison to assessment by accredited clinicians. e) To assess the performance of automated measurement of ptosis-provoking exercises through computer vision techniques applied to smartphone camera recordings for detection of ptosis, in comparison to assessment by accredited clinicians. f) To assess the correlation between digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients and their level of fatigue as measured by the Checklist Individual Strength (CIS-) fatigue subscale. | — |
Countries
Netherlands
Contacts
Public ContactYJM Campman
Leids Universitair Medisch Centrum
Outcome results
None listed