Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis

NCT ID: NCT06441825

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-10-31

Brief Summary

This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical scores and various questionnaires including sores on quality of life, sleep quality or activities of daily living. Primarily including patients treated with newly approved drugs, it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment.

Detailed Description

Myasthenia Gravis (MG) is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction. Typically, symptomatic assessments occur during clinical encounters, either as part of routine treatment assessments or in acute situations such as myasthenic crises. However, for a comprehensive understanding of mechanisms in MG and disease activity, continuous monitoring is essential.

Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures, clinical scores such as the QMG scale and MGC, as well as various questionnaires addressing sleep quality, quality of life or activities of daily living.

Data recorded by the used wearables (Withings Scanwatch 2) cover various parameters including activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep quality, etc.).

Prospectively, this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments, particularly of the newly approved drugs for MG.

In the future, wearables might hold the potential to improve treatment processes and optimize therapeutic approaches. For instance, digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena, paving the way for personalized treatment strategies tailored to individual patient needs.

Conditions

Myasthenia Gravis; Myasthenic Syndrome; Lambert-Eaton Myasthenic Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Myasthenic Syndromes Observational Cohort

Cohort to be characterized via clinical, serological and digital observations

Increased multimodal observation including digital monitoring

Intervention Type: OTHER

Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers

Interventions

Increased multimodal observation including digital monitoring

Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers

Intervention Type: OTHER

Other Intervention Names

Withings Scanwatch 2

Eligibility Criteria

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation:

• Unable or unwilling to give informed consent
• Unable or unwilling to use the smartphone app
• Any significant comorbidity that might potentially interfere with the ability to successfully participate in the study, based on investigator´s judgment
• Patient with exclusively ocular symptoms (ocular myasthenia gravis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Marc Günter Pawlitzki

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heinrich-Heine University, Duesseldorf

Düsseldorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marc Pawlitzki, PD Dr. med.

Role: CONTACT

neuro-trials@med.uni-duesseldorf.de

+49211 8117887

Facility Contacts

Marc Günter Pawlitzki, PD Dr. med.

Role: primary

neuro-trials@med.uni-duesseldorf.de

+49211 8117887

Lars Masanneck, Dr. med.

Role: backup

Other Identifiers

MPGv1.0

Identifier Type: -

Identifier Source: org_study_id