This study will make use of a cross-sectional design of MG patients and non-MG participants to quantitatively assess key MG symptoms, and to explore the applicability of machine learning algorithms to their measurement.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 18 years
2. Ability to understand the requirements of the study and provide written informed consent.
Inclusion Criteria for MG participants only:
1. A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category "definite" or "probable" MG).
2. MGFA Clinical Classification of disease severity I-IV.
3. 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
1. Subjects are not diagnosed with and have no clinical suspicion of MG.
2. 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:
1. Not willing to be audio-recorded for the study assessments.
2. Not willing to be video-recorded for the study assessments.
3. Subjects currently taking part in a clinical trial of an Investigational Medicinal Product.
4. Subjects who have used an immediate release pyridostigmine-based medication in the 12 hours prior to their participation and participants on prolonged release pyridostigmine.
5. 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:
1. Subjects with an upper-limb amputation or who are non-verbal.
2. Subjects with a diagnosed neurological disease resulting in muscle weakness, other than MG.
Exclusion Criteria for non-MG participants only:
1\. Limitation of upper limb mobility or speech impairment of any cause.
Primary outcome measure(s)
Differentiating between MG-patients and non-MG participants using digital features of dysarhtria, dysphonia, proximal arm fatigue and ptosis. — Assessed at a single time point during outpatient visit Using machine-learning algorithms.
Trial sites (2)
Facility
City
Region
Status
Leiden University Medical Center
Leiden
South Holland
Not Yet Recruiting
Leiden University Medical Center
Leiden
Netherlands
Recruiting
More Leiden University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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