Capturing Key MG-symptoms Using Smartphone Recordings.

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Capturing Key MG-symptoms Using Smartphone Recordings," is designed to study the symptoms of Myasthenia Gravis (MG), a condition that causes muscle weakness and fatigue. Researchers are looking for both MG patients and healthy individuals to participate. The goal is to use smartphone recordings to better understand key MG symptoms, such as difficulty speaking or weakness in the arms, and to see if machine learning can help measure these symptoms more effectively.

To be eligible for the study, participants must be at least 18 years old and able to provide written consent. For those with MG, they need to have a confirmed diagnosis and experience at least one of the specific symptoms being studied. Healthy participants should not have any history of the MG symptoms. If you join the study, you can expect to be audio and video recorded while discussing your symptoms. This information will help researchers gain insights into MG and improve future treatments. It's important to know that this trial is currently recruiting participants, so if you or someone you know meets the criteria, consider getting involved!

Gender

ALL

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) with the typical fluctuating muscle weakness and at least one of the following:
• • a positive serologic test for AChR or MuSK antibodies;
• • an abnormal electrodiagnostic test: repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG).
• • 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.