Interventions Against Fatigue in Patients With Myasthenia Gravis
NCT06659627
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Leiden, South Holland, Netherlands
View Trial DetailsNCT Number: NCT06743490
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leiden University Medical Center, Leiden, South Holland, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for MG participants only:
Inclusion criteria
for non-MG participants only
Exclusion criteria
Exclusion criteria
for MG participants only:
Exclusion criteria
for non-MG participants only:
Time frame: Assessed at a single time point during outpatient visit
Using machine-learning algorithms.
Time frame: Assessed at a single time point during outpatient visit
Myasthenia Gravis Composite (MGC) is scored on an ordinal scale with four possible categories and weighted and consists of 10 items with a total score of 0-50; a higher score indicating more severe disease.
Time frame: Assessed at a single time point during outpatient visit
MG Activities of Daily Living (MG-ADL) consists of 8 items with a total score of 0-24; a higher score indicating more severe disease.
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Time frame: Assessed at a single time point during outpatient visit
Clinical assessment by two independent trained speech and language pathologists (SLP) using the Therapy Outcome Measure scale (TOMS) for dysarthria and GRBAS scale (Grade, Roughness, Breathiness, Asthenia and Strain) for dysphonia.
Time frame: Assessed at a single time point during outpatient visit
Clinical assessment by accredited clinicans.
Time frame: Assessed at a single time point during outpatient visit
Clinical assessment by accredited clinicians.
Time frame: Assessed at a single time point during outpatient visit
Checklist Individual Strength (CIS-) fatigue subscale consists of 8 questions on fatigue experienced during the previous 2 weeks. Each question is scored on a 7-point Likert scale and a score ≥ 35 indicates severe fatigue. A higher score means more severe fatigue. The total score of the fatigue subscale ranges from 8-56 (the total score of the CIS questionnaire ranges from 20-140).
Contact information is provided by the study sponsor or research team.
Martijn R Tannemaat, MD, PhD
CONTACT
Yvonne JM Campman, MD
CONTACT
Leiden University Medical Center
Other
Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)
Acronym: CAPTURE - MG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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