Capturing Key MG-symptoms Using Smartphone Recordings.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, Fatigue. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)
Overview
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.
Detailed description
Due to the cross-sectional design, participants will only have to visit Leiden University Medical Center (LUMC) once. For patients already treated in the LUMC, we will try to align this visit with a standard clinical appointment.
After inclusion, all baseline data, consisting of demographics, clinical history and a number of questionnaires (four for MG participants, three for non-MG participants), will be collected. The symptom-specific assessments are performed in a standard order, with the most fatiguing task (i.e. proximal arm fatigue static assessment) last. We estimate the visit will take a total of 60 minutes.
This study is considered to be low risk. Withholding pyridostigmine for a limited period is part of standard care of MG (before investigations or clinical assessments) and does not affect long term clinical outcome. MG participants will consent to withhold pyridostigmine for 12 hours prior to the study visit if they are on this treatment and restart it after the visit. As this is a non-interventional, observational study where only questionnaire-based and non-contact digital data are being collected, the only source of marginal risk relates to data protection and confidentiality, including arrangements for the transfer and storage of data. Given it would not be possible to deidentify the digital audio or video data while maintaining the requisite integrity for data analysis, we will seek explicit consent for the sharing of this information in this identifiable format.
Primary outcome measures
- Differentiating between MG-patients and non-MG participants using digital features of dysarhtria, dysphonia, proximal arm fatigue and ptosis. [Time frame: Assessed at a single time point during outpatient visit]
Secondary outcome measures (6)
- Correlating digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients with disease severity as measured by the MGC score. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Assessed at a single time point during outpatient visit]
- Correlating digital features of dysarthria, dysphonia, proximal arm fatigue and ptosis in MG patients with their level of fatigue as measured by the CIS-fatigue subscale. [Time frame: Assessed at a single time point during outpatient visit]
Eligibility criteria
Inclusion criteria
- 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).
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/
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:
1\. Limitation of upper limb mobility or speech impairment of any cause.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Netherlands · 2 centers
- Leiden University Medical Center — Leiden
- Leiden University Medical Center — Leiden
Identifiers
NCT: NCT06743490 · NL86693.058.24