Actively Recruiting
Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)
Led by Leiden University Medical Center · Updated on 2025-09-09
225
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
H
Huma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating Myasthenia Gravis (MG) by comparing patients with MG to people without the condition using smartphone recordings. The study aims to measure key symptoms like voice and speech difficulties, arm fatigue, and eyelid drooping. It also explores how machine learning can help analyze these symptoms. This observational study is conducted by Leiden University Medical Center and involves a one-time visit for all participants. Participants will attend a single visit at Leiden University Medical Center, lasting about 60 minutes. During this visit, demographic information, clinical history, and various questionnaires will be collected. MG patients may be asked to withhold their usual pyridostigmine medication for 12 hours before the visit if applicable. The study includes assessments of symptoms using smartphone audio and video recordings, focusing on tasks that measure speech, arm fatigue, and eyelid drooping. During the visit, researchers will collect baseline data and perform symptom-specific tests in a set order, with the most tiring tasks last. They will also use questionnaires tailored for MG patients and controls. The study will compare digital features from recordings to clinical assessments and measure how symptoms relate to disease severity and daily activity impact. Data protection and confidentiality are carefully managed, and participants' involvement is limited to this single visit.
CONDITIONS
Brief Title
Capturing Key MG-symptoms Using Smartphone Recordings.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to understand the study and provide written informed consent
- For MG participants: clinical diagnosis of myasthenia gravis (ocular or generalized) per Dutch guidelines
- MGFA Clinical Classification of disease severity I-IV for MG patients
- MG participants must have at least one symptom of interest: dysarthria, dysphonia, proximal arm fatigue, or ptosis
- For non-MG participants: no diagnosis or suspicion of MG
- Non-MG participants must have no history of the symptoms of interest
You will not qualify if you...
- Unwilling to be audio-recorded
- Unwilling to be video-recorded
- Currently participating in a clinical trial of an Investigational Medicinal Product
- Used immediate release pyridostigmine within 12 hours prior to participation or on prolonged release pyridostigmine
- Cognitive or physical limitations that prevent completing study procedures
- For MG participants: upper-limb amputation or non-verbal
- For MG participants: diagnosed neurological disease causing muscle weakness other than MG
- For non-MG participants: limited upper limb mobility or speech impairment from any cause
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit lasting approximately 60 minutes
Participants complete baseline data collection including demographics, clinical history, questionnaires, and symptom-specific assessments using smartphone recordings to capture symptoms such as dysarthria, dysphonia, proximal arm fatigue, and ptosis.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Not Yet Recruiting
2
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
Research Team
M
Martijn R Tannemaat, MD, PhD
Y
Yvonne JM Campman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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