Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis

NCT06441825 | Recruiting

• 1 other identifier: MPGv1.0
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis; Myasthenic Syndrome; Lambert-Eaton Myasthenic Syndrome

Outcome Measures

Primary Outcomes (5)

• QMG: Quantitative Myasthenia Gravis Scale

  The QMG-Score is a clinical tool to assess the severity of symptoms in MG. It evaluates muscle strength and function in specific muscle groups (ocular, oral, facial, neck and limb muscles), grip strength and vital capacity. It ranges from 0 to 39, with higher scores indicating an increased symptom load.

  6 months, monthly

• MGC: Myasthenia Gravis Composite

  The MGC is a clinical tool to evaluate the severity and progression of MG. It ranges from 0 to 50, with higher scores indicating a higher severity of MG.

  Baseline, after 3 and 6 months

• MGFA-PIS: Myasthenia Gravis Post intervention status

  The MGFA-PIS is a scoring system used to assess the status of patients with MG. It divides MG presentations into different classes, classifying outcome measures and treatment effectiveness. It has 8 classes; Minimal Manifestation can be further described within four dimensions.

  Baseline, after 3 and 6 months

• MG-ADL: Myasthenia Gravis Activities of Daily Living

  The MG-ADL is a tool used to assess the functional status of patients with MG in their daily activities. It consists of questions related to various activities of daily living such as speaking, chewing, swallowing, walking etc. It ranges from 0 to 24, with higher scores indicating a greater impairment in daily life.

  Baseline, after 3 and 6 months

• MG-QoL15: Myasthenia Gravis Quality of Life-15

  The MG-QoL assesses the quality of life in patients with MG, covering various aspects of daily life such as physical functioning, social interactions, emotional well-being and overall satisfaction with life. It ranges from 0 to 60, with higher scores indicating a greater impact of MG on life quality.

  Baseline, after 3 and 6 months

Secondary Outcomes (30)

• WHOQoL-BREF: World Health Organization Quality of Life Questionnaire Brief Version

  Baseline, after 3 and 6 months

• HADSD: Hospital Anxiety and Depression Scale

  Baseline, after 3 and 6 months

• EoD-Questionnaire: End of Dose-Questionnaire

  Baseline, after 3 and 6 months

• Sleep-Questionnaire:

  Baseline, after 3 and 6 months

• 10. Questionnaire on Smartwatch Usage (after 6 Months) containing the System Usability Scale

  After 6 months

Study Arms (1)

Myasthenic Syndromes Observational Cohort

Cohort to be characterized via clinical, serological and digital observations

Other: Increased multimodal observation including digital monitoring

Interventions

Increased multimodal observation including digital monitoring OTHER

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

Also known as: Withings Scanwatch 2

Myasthenic Syndromes Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with myasthenic syndromes treated at the University Clinic Duesseldorf.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich-Heine University, Duesseldorf

Düsseldorf, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

\- Blood serum

MeSH Terms

Conditions

Myasthenia Gravis; Lambert-Eaton Myasthenic Syndrome

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Marc Pawlitzki, PD Dr. med.

CONTACT

+49211 8117887; neuro-trials@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: May 2, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

DE (1)