Myasthenia GravisNCT07146425
Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chong Yan, Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, affiliated to Fudan University
Shanghai
Chong Yan, Ph.D.
About this study
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.
Read the detailed description
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:
- Whether digital phenotyping can comprehensively represent the disease characteristics and severity gradations in MG.
- The feasibility of using multimodal digital phenotypic modeling for the objective evaluation of MG.
- The challenges and obstacles faced by the AI-enhanced medical model in clinical demonstration applications.
The study is focused on three main objectives:
- Perform a descriptive analysis and comparison of phenotypic data across various subgroups to pinpoint key characteristics associated with MG disease grade and scale score.
- Construct a digital evaluation model for MG patients using chosen features, validate the model with prospectively gathered data, and conduct a correlative analysis with the clinical functional scales to assess its effectiveness on predicting MG symptom grading and disease progression.
- Develop a patient-centric remote evaluation system utilizing the refined MG digital evaluation model to facilitate its application in real-world clinical settings.
- Conditions
- Myasthenia Gravis
- Keywords
- Digital assessment, Digital phenotype, Eye movement, Multimodal
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myasthenia gravis patients | Patients were diagnosed of myasthenia gravis | |
| Healthy subjects | Healthy individuals of similar age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (single study visit)
Secondary outcomes (2)
Interclass Correlation Coefficient (ICC) of the Digital Outcome Assessment Model
This outcome measure will assess test-retest reliability of the digital assessment.
Measured: Baseline and Week 2
Prospectively validate the model effectiveness
This outcome measure prospectively validates the scoring effectiveness in a prospectively enrolled MG cohort
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start31 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chongbo Zhao, Huashan Hospital
- Investigators
- Chongbo Zhao, Ph.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146425
- Sponsor's protocol ID
- KY2023-664
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07146425
- Acronym / sponsor ID
- KY2023-664
- Conditions
- Myasthenia Gravis
- Keywords
- Digital assessment, Digital phenotype, Eye movement, Multimodal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Whether digital phenotyping can comprehensively represent the disease characteristics and severity gradations in MG.
- The feasibility of using multimodal digital phenotypic modeling for the objective evaluation of MG.
- The challenges and obstacles faced by the AI-enhanced medical model in clinical demonstration applications.
The study is focused on three main objectives:
- Perform a descriptive analysis and comparison of phenotypic data across various subgroups to pinpoint key characteristics associated with MG disease grade and scale score.
- Construct a digital evaluation model for MG patients using chosen features, validate the model with prospectively gathered data, and conduct a correlative analysis with the clinical functional scales to assess its effectiveness on predicting MG symptom grading and disease progression.
- Develop a patient-centric remote evaluation system utilizing the refined MG digital evaluation model to facilitate its application in real-world clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myasthenia gravis patients | – | –Patients were diagnosed of myasthenia gravis |
| Healthy subjects | – | –Healthy individuals of similar age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive Analysis and Comparison of Digital Phenotypic Data across Subgroups
Time frame: At baseline (single study visit)
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.
Correlation Between Digital Evaluation Model and Quantitative Myasthenia Gravis (QMG) Scale
Time frame: At baseline (single study visit)
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.
2 secondary outcomes
Interclass Correlation Coefficient (ICC) of the Digital Outcome Assessment Model
Time frame: Baseline and Week 2
Prospectively validate the model effectiveness
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chong Yan, Ph.D. contact
Chongbo Zhao, Ph.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanan Miao, Ph.D. (0086-021-52888780, himed@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Analysis and Comparison of Digital Phenotypic Data across Subgroups (time frame: At baseline (single study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.