NCT06381284

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 215 (actual)
• Sponsor: ZS Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Myasthenia Gravis
• Neuromuscular Manifestations
• Neuromuscular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Social media recruitment	Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment
BEHAVIORAL	Self-Assessment	Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups
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

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-03-03
• Completion: 2025-03-03
• First posted: 2024-04-24
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States