NCT06743490 Capturing Key MG-symptoms Using Smartphone Recordings.
| NCT ID | NCT06743490 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2026-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2025-03-18 with a primary completion date of 2026-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Martijn R. Tannemaat, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06743490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06743490 currently recruiting?
Yes, NCT06743490 is actively recruiting participants. Contact the research team at m.r.tannemaat@lumc.nl for enrollment information.
Where is the NCT06743490 trial being conducted?
This trial is being conducted at Leiden, Netherlands, Leiden, Netherlands.
Who is sponsoring the NCT06743490 clinical trial?
NCT06743490 is sponsored by Leiden University Medical Center. The principal investigator is Martijn R. Tannemaat, MD, PhD at Leiden University Medical Center. The trial plans to enroll 225 participants.