Validation and Scaling of Screening Program for Undiagnosed Myasthenia Gravis-Social Media Campaign Paired With a Self-moderated Assessment

NCT06866483 | Recruiting

• 1 other identifier: MG-002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study expands and validates the pilot study NCT06381284. It is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The primary objective is to determine the validity of a self-assessment tool in encouraging undiagnosed participants, recruited through a social media campaign, to seek medical evaluation for suspected myasthenia gravis (MG).

Conditions

Myasthenia Gravis; Neuromuscular Disease; Neuromuscular Manifestations

Keywords

social media; myasthenia gravis

Outcome Measures

Primary Outcomes (1)

• Self-Assessment tool validity

  Measure the specificity and sensitivity of the Self-Assessment tool

  6 months from time of enrollment

Secondary Outcomes (1)

• Social media engagement

  Enrollment period (~4-5 months)

Other Outcomes (1)

• Time to diagnosis

  6 months from time of enrollment

Study Arms (1)

Participants with undiagnosed neuromuscular symptoms

Behavioral: Social media recruitment; Behavioral: Self-Assessment; Behavioral: Follow-up

Interventions

Social media recruitment BEHAVIORAL

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

Participants with undiagnosed neuromuscular symptoms

Self-Assessment BEHAVIORAL

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

Participants with undiagnosed neuromuscular symptoms

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

Participants with undiagnosed neuromuscular symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants who have undiagnosed neuromuscular symptoms

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ZS Associates: lead
• UCB Pharma: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

ZS Associates

Evanston, Illinois, 60201, United States

RECRUITING

Related Links

• Study enrollment webpage

MeSH Terms

Conditions

Myasthenia Gravis; Neuromuscular Diseases; Neuromuscular Manifestations

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ananda Vishnu Pandurangadu, MD

CONTACT

1-847-448-1001; support@unearthrootcause.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: February 26, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (1)