Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment

This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG).

Study Overview

• Status: Completed
• Conditions: Neuromuscular Diseases; Neuromuscular Manifestations; Myasthenia Gravis
• Intervention / Treatment: Behavioral: Social media recruitment; Behavioral: Follow-up; Behavioral: Self-Assessment

Detailed Description

Participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). Two assessment tools were developed by the study team: the Impact of Daily Living (IDL) Survey and the MG Exercise Assessment. Both tools were designed using supporting literature, accepted guidelines, and a rigorous review via a panel of practicing neurologist key opinion leaders experienced in treating MG patients.

Adult participants who don't have specific diagnosed neurologic conditions will first be screened for eligibility based on the results of the IDL survey which will query participants on the presence or absence of habits/symptoms characteristic of MG. Those who qualify will complete the MG Exercise Assessment in which participants are provided video instructions to perform a series of 10 physical tests to examine if specific muscle groups undergo inducible fatigue. The results of the MG Exercise Assessment are reviewed by a neurologist to determine if participants would benefit further from an in-person neurologist evaluation for MG by a provider. Each participant is provided with a report of the neurologist's evaluation. Participants will be followed for 1 year through bimonthly communications to determine if and when they followed up with a clinician and if they received a confirmed diagnosis of myasthenia gravis.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • ZS Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult participants who have undiagnosed neuromuscular symptoms

Description

Inclusion Criteria:

• Reside within the 50 states of the United States at the time of enrollment
• Age 19 or older if reside in Nebraska or Alabama, Age 21 or older if reside in Mississippi, Age 18 years or older if reside in any other state
• Active email account
• Fluency in English (spoken / written), as demonstrated by the ability to read and sign the Informed Consent Form

Exclusion Criteria:

• Live in an overseas territory of the United States
• Inability or unwillingness to provide written informed consent
• Diagnosed myasthenia gravis
• Diagnosed multiple sclerosis
• Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with undiagnosed neuromuscular symptoms

Behavioral: Social media recruitment; Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment; Behavioral: Follow-up; Patients triaged based on their assessed risk of MG are asked to complete recommended follow-up with a clinician to determine presence of myasthenia gravis; Behavioral: Self-Assessment; Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social media recruitment feasibility	Measure the engagement and feasibility metrics of the social media campaign	Enrollment period (4-6weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MG Exercise Assessment Tool validity	Estimate preliminary measures of validity for the MG Exercise Assessment Tool	1 year from time of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnosis	Evaluate the time to diagnosis for any participant who has a confirmed diagnosis of MG after the completion of the study compared to that reported in literature	1 year from time of enrollment

Collaborators and Investigators

• Sponsor: ZS Associates
• Collaborators: UCB Pharma; University of California, San Francisco
• Investigators: Principal Investigator: Ananda Vishnu Pandurangadu, MD, ZS Associates

Publications and helpful links

Helpful Links

• Study landing page

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Myasthenia Gravis; Social Media
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis; Neuromuscular Diseases; Neuromuscular Manifestations
• Other Study ID Numbers: MG-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No