NCT06743490

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2025Sep 2026

First Submitted

Initial submission to the registry

December 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 18, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

December 9, 2024

Last Update Submit

July 6, 2026

Conditions

FatigueMyasthenia Gravis

Keywords

Myasthenia GravisFatigueDigital featuresMachine Learning AlgorithmsDysarthriaDysphoniaProximal arm fatiguePtosis

Outcome Measures

Primary Outcomes (1)

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

    Using machine-learning algorithms.

    Assessed at a single time point during outpatient visit

Secondary Outcomes (6)

  • Correlating digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients with disease severity as measured by the MGC score.

    Assessed at a single time point during outpatient visit

  • Correlating digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients with the impact of MG on daily activities as measured by the MG-ADL.

    Assessed at a single time point during outpatient visit

  • The performance of automated signal processing of speech recordings collected through smartphone microphone for detection of dysarthria and dysphonia compared to clinical assessment.

    Assessed at a single time point during outpatient visit

  • The performance of automated measurement of proximal arm-fatiguing exercises through computer vision techniques applied to smartphone camera recordings for detection of proximal arm muscle weakness and fatigability compared to clinical assessment.

    Assessed at a single time point during outpatient visit

  • The performance of automated measurement of ptosis-provoking exercises through computer vision techniques applied to smartphone camera recordings for detection of ptosis compared to clinical assessment.

    Assessed at a single time point during outpatient visit

  • +1 more secondary outcomes

Study Arms (2)

MG patients

MG patients with at least one of the symptoms of interest (i.e. dysarthria, dysphonia, proximal arm fatigue and/or ptosis). We aim to include 150 patients with Myasthenia Gravis.

Non-MG participants

Non-MG participants that do not have a medical history of any of the symptoms of interest. We aim to include 75 controls.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We aim to include 150 patients with Myasthenia Gravis, recruited from the national Dutch-Belgia MG registry, the patient organisation 'Spierziekten Nederland' or identified by the clinical team of Leiden University Medical Center (LUMC). Non-MG participants are preferentially sampled from friends and family of enrolled MG patients. The highest preference will be same-household family members, lowest preference will be non-household non-family members. This acts as both a natural source of control participants and a natural control for any environmental confounders. Furthermore, non-MG participants will be recruited separately by placing flyers in crowded areas in the LUMC.

You may qualify if:

  • 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).

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/
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Myasthenia GravisFatigueDysarthriaDysphoniaBlepharoptosis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsVoice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesEyelid DiseasesEye Diseases

Study Officials

  • Martijn R. Tannemaat, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn R Tannemaat, MD, PhD

CONTACT

+31715262197m.r.tannemaat@lumc.nl

Yvonne JM Campman, MD

CONTACT

+31715262118y.j.m.campman@lumc.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 20, 2024

Study Start

March 18, 2025

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)