MyoSense 360 in generalized myasthenia gravis: testing digital monitoring to track change

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 exploratory study aims to see if MyoSense 360 digital measures can model the trajectory of generalized MG over 12 months in real-world settings. The primary goal is to identify changes in MG-ADL scores of ±2 points as clinically meaningful markers of disease evolution. Secondary goals include evaluating how usable the device is, how well participants adhere to the protocol, and whether the models can predict worsening or exacerbations. Safety and any adverse device effects are monitored throughout the study. The findings will inform refinement of the device and planning for a pivotal trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years at screening
* Patients with gMG diagnosis confirmed by the investigator based at least on one of the following:
* Positive antibody testing for ACHR or MuSK antibodies; or,

  * LRP-4 antibodies or seronegative patients with additional positive single fiber examination; or,
  * Abnormal single-fiber EMG (SFEMG) jitter in at least one clinically weak muscle; or,
  * Objective evidence of improvement of clinical gMG symptoms following treatment with oral AChEI or positive pyridostigmine or neostigmine or edrophonium test
* MGFA Class IIa to IVb
* Having read the information sheet and signed the informed consent form
* Owning and able to use a personal smartphone which software version is above 16 for iOS and 8 for Android included
* Able to read languages in which the mobile application is available and able to understand pictograms (MyoSense 360 is available in local official languages)
* Able to use an activity monitor (per Actigraph LEAP activity monitor wearability criteria; see vendor guidance)
* For France only, affiliated with or benefiting from a social security system

Exclusion Criteria:

* Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
* Person under guardianship or curatorship
* Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
* Participant has participated in another interventional clinical study within 30 days prior to screening or who are currently enrolled in another study that, in the - Investigator's opinion, could interfere with their full participation in this study or confound the assessment of the subject or study outcomes
* For France only, participant who has received more than €6,000 in compensation over the past 12 months for participating in human research, clinical trials, clinical investigations or performance studies.

Where it's running

• CHU de Brest, La Cavale Blanche
  Brest, Brittany Region, France Recruiting
• Hôpital Pierre Paul Riquet
  Toulouse, France Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Rigshospitalet
  Copenhagen, Denmark Not yet recruiting
• CH Raymond Poincaré
  Garches, France Not yet recruiting
• CHRU de Nancy
  Nancy, France Not yet recruiting

Similar studies

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

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• Observational study on ravulizumab for generalized myasthenia gravis

  This study is looking at how well ravulizumab works for people with generalized myasthenia gravis over three years to see how it helps their health.

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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.