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RECRUITINGOBSERVATIONAL

Capturing Key MG-symptoms Using Smartphone Recordings.

Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years 2. Ability to understand the requirements of the study and provide written willing to sign a consent form. 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). Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (2)

Leiden University Medical Center
Leiden, South Holland, Netherlands
Leiden University Medical Center
Leiden, Netherlands