RecruitingNCT06743490
Capturing Key MG-symptoms Using Smartphone Recordings.
Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)
Sponsor
Leiden University Medical Center
Enrollment
225 participants
Start Date
Mar 18, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria7
- Age ≥ 18 years
- Ability to understand the requirements of the study and provide written informed consent.
- 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).
- 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 Criteria8
- 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.
- Subjects have cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to complete study procedures/
- Subjects with an upper-limb amputation or who are non-verbal.
- Subjects with a diagnosed neurological disease resulting in muscle weakness, other than MG.
- \. Limitation of upper limb mobility or speech impairment of any cause.
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Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06743490
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