Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis

NCT07146425 | Recruiting

• 1 other identifier: KY2023-664
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myasthenia Gravis

Keywords

Digital assessment; Digital phenotype; Eye movement; Multimodal

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Interclass Correlation Coefficient (ICC) of the Digital Outcome Assessment Model

  Baseline and Week 2

• Prospectively validate the model effectiveness

  1 year

Study Arms (2)

Myasthenia gravis patients

Patients were diagnosed of myasthenia gravis

Healthy subjects

Healthy individuals of similar age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• For Patients with MG
• Patients have a confirmed diagnosis of myasthenia gravis and be over 18 years old.
• Patients have the clinical classification of Myasthenia Gravis Foundation of America (MGFA) within I-IV, or be asymptomatic after treatment.
• Patients must sign the informed consent form and the privacy confidentiality agreement.
• For Healthy Participants
• Age group matched with MG participants

You may not qualify if:

• For Patients with MG
• Patients are in the crisis stage of myasthenia gravis (MGFA class V) and unable to cooperate with scoring.
• Patients are with severe cardiopulmonary diseases and unable to cooperate with the scoring.
• Patients with any psychiatric disorder or cognitive dysfunction that, in the investigator's judgment, may interfere with their participation in the study.
• Patients with any other unspecified unstable medical condition.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, affiliated to Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

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

Study Officials

• Chongbo Zhao, Ph.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanan Miao, Ph.D.

CONTACT

0086-021-52888780; himed@fudan.edu.cn

Chong Yan, Ph.D.

CONTACT

yanc_huashan@163.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 28, 2025
• Study Start: August 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)