Not yet recruiting NCT07323316

Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360

No phase Interventional Myasthenia Gravis, Generalized

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: MyoSense 360.
Who it may be relevant to: Registry conditions: Myasthenia Gravis, Generalized. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study. The primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +/- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening/exacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.

Interventions

Device MyoSense 360
The investigational version of MyoSense 360 consists of two mobile applications running on the patient's smartphone (CentrePoint Connect and InClinical), an ActiGraph LEAP activity monitor (Ametris product), as well as two cloud computing platforms

Primary outcome measures

To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions. [Time frame: 12 months]

Secondary outcome measures (11)

To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to predict sustained worsening within a one-month forward-looking window [Time frame: 1 month]
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline. [Time frame: 4 weeks]
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline. [Time frame: 4 weeks]
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline. [Time frame: 4 weeks]
To describe the association between MyoSense 360 active functional tests measures obtained at home without supervision and the standard reference Quantitative Myasthenia Gravis (QMG) sub-items performed under clinical supervision at baseline [Time frame: Day 0 and Day 1]
To describe the association between digital measures from MyoSense 360 (ActiGraph LEAP data collection, active smartphone functional tests and electronic Patient-Reported Outcomes) and clinical and patient-reported outcome measures [Time frame: 12 months]
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed [Time frame: 12 months]
To describe the usability of MyoSense 360, including ActiGraph LEAP data collection, active functional tests and ePROs, from the patient's perspective. [Time frame: Days 1, 180 and 345]
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed [Time frame: 12 months]
To describe overall patient satisfaction and perceived benefits of using MyoSense 360 in daily life [Time frame: Days 1, 180 and 345]
To monitor the incidence, type, and severity of adverse events and device deficiencies related to the use of MyoSense 360. [Time frame: 390 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07323316 · ADS-HARMONY360-2025

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗