Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares

July 27, 2021 updated by: doc.ai inc

A Digital Health Trial That Assesses Participant-driven Data Collection Using Smartphone Modules to Characterize Myasthenia Gravis Symptoms and Develop an A.I. Model to Predict Flares

There are limited objective measurements of MG symptoms as well as a dearth of data at a granular level of MG (myasthenia gravis) symptoms and triggers occurring longitudinally.

This study is designed to use the strengths of mobile smartphones which enable participant-driven real time capture of data manually and through augmented sensors such as video and audio, in order to better characterize MG symptoms and flares.

The study aims to enroll approximately 200 participants for approximately 9 months until analyzable data is available from at least 100 participants. Participants will complete in-app surveys for 3 months with, audiovisual recording of symptoms. This will take approximately 35 minutes per week after the initial survey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using their smartphones, potential participants will download the doc.ai research mobile app. There will be a web pre-screening link where potential participants will self-screen to see if they meet the basic eligibility criteria for this study. The recruitment tool for this trial is developed for diversity, fairness, and inclusion. With the aim to ensure diversity in the demographics of the trial to better understand the health needs of different populations. So, while some interested potential participants do qualify, they may not be invited into the trial due to these diversity requirements.

Patients with myasthenia gravis (MG) who meet the inclusion criteria will be invited to join this digital health trial. Participants will sign the e-consent and self-enroll into the study. Once their eligibility is confirmed by the study team (to ensure eligibility criteria and validity of participant i.e. eliminate robo sign-ins) they will be asked to take a selfie, provide documented proof of MG diagnosis, respond to a series of survey questions regarding their demographics, current health, medical history, and other MG related information.

Enrolled participants will have a daily brief check-in, 2 weekly check-ins and a weekly check-in which will include an audiovisual check-in, and will maintain an audiovisual diary to keep track of their symptoms, connect data, record their voice (to detect vocal symptoms: weakness, nasality) and take videos of their face (to detect facial symptoms: ocular, mouth droop) on a daily to weekly basis through the various data collecting modules in the doc.ai research app for the duration of their study participation. doc.ai's digital health trial platform will be leveraged to collect this data.

The study aims to enroll approximately 200 participants in approximately 9 months. It is expected that a minimum of 100 participants will be included in the final analysis as at any given time there will be a lag between potential participants expressing interest in the study, their eligibility being assessed by the PI, and participants completing all required study procedures.

At the end of their participation, participants will be asked to complete a questionnaire. After the participant has completed their final survey, they will be able to connect to a link redeemable as an Amazon.com gift card worth $250. All participants will also receive an end-of-trial-summary of the data that they had collected during the study. No medical advice or direction will be given based on this study.

In addition, in the final survey participants will be asked if they would be willing to complete a usability interview after their participation in this trial has ended. This subset of participants invited to be part of a follow-up usability interview will include those who complete all study required procedures and some who may not have completed all study required procedures, in order to assess usability experience of the app for the duration of their participation. Participants will be contacted at their end of their period of participation until a total of 10-15 participants successfully complete the usability interview. Participants who successfully complete the usability interview will receive a link for a $50 in Amazon.com gift card via the app.

For this study the data and, audio and video recordings will be captured directly on the doc.ai research app and securely stored on a HIPAA compliant cloud provider (Google Cloud Platform).

This data will be used to understand the patterns of symptoms and triggers in order to better characterize factors such as the length and timing of flares and any unique symptom patterns in order to create more objective measures of MG symptoms. Ultimately this data would be used to build a machine learning model that could predict MG symptom flares.

Primary Objective:

Use a collection of digital health modules on the smartphone to collect myasthenia gravis (MG) symptoms and triggers to better characterize symptom patterns and flares.

Secondary Objective:

Use the data collected to develop an A.I. model to detect and/or predict symptom flares.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Doc.Ai Mobile Based

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with myasthenia gravis (MG) who meet the inclusion criteria will be invited to join this digital health trial.

There will be a web pre-screening link where potential participants will self-screen to see if they meet the basic eligibility criteria for this study. The recruitment tool for this trial is developed for diversity, fairness, and inclusion. With the aim to ensure diversity in the demographics of the trial to better understand the health needs of different populations. So, while some interested potential participants do qualify, they may not be invited into the trial due to these diversity requirements.

Description

Inclusion Criteria:

  1. Must have a documented diagnosis of Myasthenia Gravis
  2. Must have ocular (eye drooping) and/or bulbar (speech) symptoms
  3. Must be over the age of 18
  4. Must reside in the US for the duration of the study
  5. Must be able to read, understand, and write in English
  6. Must have a smartphone supported by the doc.ai research app (iOS and Android)

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiovisual recording of voice exercises to detect patterns and changes in voice and facial symptoms
Time Frame: After enrollment, 3 months with in-app twice a week audiovisual recording of symptoms.

participants to complete the audio and visual data modules designed to capture patient MG symptoms (especially ocular and voice).

e.g

  • Vocal e.g.:

    • Say "papapapa" for 4 seconds
    • Say "tatatatata" for 4 seconds
    • Say "kakakaka" 4 seconds
    • Say "mamamama" 4 seconds
    • Say "papapapa" 4 seconds
    • Say "buttercup, buttercup, buttercup" 4 seconds
    • Say "aaaahhh" and hold it as long as you can

  • Counting e.g.:

    • Look straight at the camera for 4 seconds
    • Count as precisely as possible from 1 to 25 while looking up
    • Look straight at the camera for 4 seconds

The recordings will be used to detect change from baseline and any patterns that may occur. This will be used to analyze where and if different features are linked to see if a single or combined effect of the features is connected to flare frequency and/or severity.
After enrollment, 3 months with in-app twice a week audiovisual recording of symptoms.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of MG-Quality of Life assessment
Time Frame: Approximately 10 minutes each week for 3 months.
Participants complete MG activities of Daily living and MG-Quality of Life assessments weekly. This assessment has been adapted from www.myasthenia.org/healthprofessionals/educationalmaterials.aspx
Approximately 10 minutes each week for 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

doc.ai inc

Collaborators

UCB Biopharma SRL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2020

Primary Completion (ACTUAL)

July 26, 2021

Study Completion (ACTUAL)

July 26, 2021

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-005-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be reviewed, and analysis will be done by personnel of doc.ai, and the medical experts. Population-level results of the data analysis in the form of a presentation/report, as well as the resulting proof-of-concept predictive AI model, will be shared with UCB Biopharma (SRL) (who are funding this study). No participant PII or PHI will be shared with UCB Biopharma (SRL) or any other 3rd parties.

IPD Sharing Time Frame

At the end of the study, upon completion of the analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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