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OpenTrials
Completed

NCT Number: NCT06381284

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social media recruitment

Behavioral

Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment

Self-assessment

Behavioral

Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups

follow-up

Behavioral

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

Primary outcomes

  1. Social media recruitment feasibility

    Time frame: Enrollment period (4-6weeks)

    Measure the engagement and feasibility metrics of the social media campaign

Secondary outcomes

  1. MG Exercise Assessment Tool validity

    Time frame: 1 year from time of enrollment

    Estimate preliminary measures of validity for the MG Exercise Assessment Tool

Other outcomes

  1. Time to diagnosis

    Time frame: 1 year from time of enrollment

    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

Sponsors and collaborators

Lead sponsor

ZS Associates

Industry

Collaborators

  • UCB Pharma
  • University of California, San Francisco

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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