Using smartphone recordings to assess symptoms of Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to quantitatively assess key symptoms of Myasthenia Gravis (MG) using smartphone recordings from both MG patients and non-MG participants. Participants will visit the Leiden University Medical Center once, where baseline data, including demographics and clinical history, will be collected alongside symptom-specific assessments. The study will explore the applicability of machine learning algorithms to analyze the recorded data, focusing on symptoms such as dysarthria and fatigue. The study is considered low risk, primarily involving questionnaire-based assessments and digital data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, South Holland, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Martijn R. Tannemaat, MD, PhD — Leiden University Medical Center
• Study coordinator: Martijn R Tannemaat, MD, PhD
• Email: m.r.tannemaat@lumc.nl
• Phone: +31715262197

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• Micro-choice-based approach to fatigue management

  A small study in Basel will test a new four-day group program using micro-choices to help people with fatigue from multiple causes see if it’s doable, acceptable, and may help daily functioning.

  Recruiting University Hospital, Basel, Switzerland · Basel · NCT07726082

• HBS-301 for Narcolepsy: daily wakefulness and sleepiness improvement in adults

  This Phase 3 study tests HBS-301 vs placebo in adults with narcolepsy to see if it helps with daytime sleepiness, cataplexy, sleepiness, and fatigue.

  Recruiting at 29 sites Phase 3 Harmony Biosciences Management, Inc. · Birmingham, Alabama and 52 other locations · NCT07675135

• Ublituximab maintenance after efgartigimod response in myasthenia gravis

  This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.

  Recruiting at 7 sites Phase 2 TG Therapeutics, Inc. · Colorado Springs, Colorado and 6 other locations · NCT07673744

• See if Nuvastatic helps with cancer-related fatigue in colon cancer patients on first-line chemotherapy

  This trial tests whether Nuvastatic can lessen fatigue in adults with colon cancer who are receiving their first round of chemotherapy, compared to placebo.

  Recruiting at 6 sites Phase 3 Natureceuticals Sdn Bhd · Srikakulam, Andhra Pradesh and 5 other locations · NCT07669519

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.