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

NCT ID: NCT06381284

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-28

Study Completion Date

2025-03-03

Brief Summary

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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

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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

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Myasthenia Gravis Neuromuscular Manifestations Neuromuscular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with undiagnosed neuromuscular symptoms

Social media recruitment

Intervention Type BEHAVIORAL

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

Self-Assessment

Intervention Type BEHAVIORAL

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

Follow-up

Intervention Type 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

Interventions

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Social media recruitment

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

Intervention Type BEHAVIORAL

Self-Assessment

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

ZS Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Ananda Vishnu Pandurangadu, MD

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ananda Vishnu Pandurangadu, MD

Role: PRINCIPAL_INVESTIGATOR

ZS Associates

Locations

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ZS Associates

Evanston, Illinois, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MG-001

Identifier Type: -

Identifier Source: org_study_id

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