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This research is a single-center, exploratory, observational study to be carried out in the outpatient or inpatient ward of the Neurology Department at Huashan Hospital, affiliated to Fudan University. The aim is to develop a digital assessment model for Myasthenia Gravis by gathering multimodal digital phenotypic data from MG patients. This includes physiological signals, facial videos, eye movements, speech, limb movements, various scales, and quality of life metrics.
The goal is to define the multimodal digital phenotypes of myasthenia gravis patients, determine the specificities of their symptoms, and develop a digital evaluation model and remote assessment system that is objective, precise, and user-friendly. This will provide a scientific foundation and technical support for diagnosing, treating, and rehabilitating individuals with MG.
Key issues to be addressed include:
The study is focused on three main objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myasthenia gravis patients | Patients were diagnosed of myasthenia gravis | ||
| Healthy subjects | Healthy individuals of similar age |
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Analysis and Comparison of Digital Phenotypic Data across Subgroups | Quantitative descriptive analysis of multimodal digital phenotypic data (motor performance, ocular metrics, and speech-derived features) to compare subgroup-specific patterns among patients with myasthenia gravis. Metrics will include summary statistics (mean, standard deviation, distribution profiles) for each modality, with subgroup comparisons performed to assess variability. | At baseline (single study visit) |
| Correlation Between Digital Evaluation Model and Quantitative Myasthenia Gravis (QMG) Scale | This outcome measure will assess the convergent validity of the digital evaluation model by calculating the correlation coefficient (Pearson's or Spearman's) between the model-derived composite score and the Quantitative Myasthenia Gravis (QMG) clinical scale score in patients with myasthenia gravis. | At baseline (single study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Interclass Correlation Coefficient (ICC) of the Digital Outcome Assessment Model | This outcome measure will assess test-retest reliability of the digital assessment. | Baseline and Week 2 |
| Prospectively validate the model effectiveness |
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Inclusion Criteria:
For Patients with MG
For Healthy Participants
Exclusion Criteria:
For Patients with MG
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This study is designed to include 150 outpatients and inpatients, with 55 cases of MGFA class I, 65 cases of class II, 15 cases of class III, 5 cases of class IV, and 10 cases of myasthenia gravis that have achieved symptom relief after treatment. Additionally, about thirty age-matched healthy subjects are expected to be recruited from the hospital staff. To minimize the impact of cholinesterase inhibitors on clinical assessments, pyridostigmine bromide should be withheld for 10 hours prior to each data collection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Miao, Ph.D. | Contact | 0086-021-52888780 | himed@fudan.edu.cn | |
| Chong Yan, Ph.D. | Contact | yanc_huashan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chongbo Zhao, Ph.D. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, affiliated to Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This outcome measure prospectively validates the scoring effectiveness in a prospectively enrolled MG cohort
| 1 year |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |