Capturing Key MG-symptoms Using Smartphone Recordings.

Recruiting now

Conditions studied: Myasthenia Gravis, Fatigue

In brief

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.

Key facts

Study ID

NCT06743490

Run by

Leiden University Medical Center

People needed

225

Starts

2025-03-18

Expected to finish

2026-09-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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/
• 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 Criteria for non-MG participants only:
• Limitation of upper limb mobility or speech impairment of any cause.

Where it is running

• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, South Holland, Netherlands

Full record on ClinicalTrials.gov

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