Clinical trial · Observational
Capturing Key MG-symptoms Using Smartphone Recordings.
Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)
NCT06743490CI-TRIAL-00117200CAPTURE - MGrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- MG patients
- description
- 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.
- label
- Non-MG participants
- description
- Non-MG participants that do not have a medical history of any of the symptoms of interest. We aim to include 75 controls.
Primary outcomes (1)
- measure
- 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
- description
- Using machine-learning algorithms.
Secondary outcomes (6)
- measure
- Correlating digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients with disease severity as measured by the MGC score.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.