RecruitingNot Applicable

Capturing Key MG-symptoms Using Smartphone Recordings.

Netherlands225 participantsStarted 2025-03-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Differentiating between MG-patients and non-MG participants using digital features of dysarhtria, dysphonia, proximal arm fatigue and ptosis.

Timeframe: Assessed at a single time point during outpatient visit

Trial details

NCT IDNCT06743490

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-01

Contact for this trial

Martijn R Tannemaat, MD, PhD

+31715262197 m.r.tannemaat@lumc.nl

View on ClinicalTrials.gov More Myasthenia Gravis trials