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

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).

Study Overview

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

Detailed Description

The pilot study (NCT06381284) demonstrated the feasibility of using social media to recruit participants with undiagnosed MG-like neuromuscular symptoms. It also successfully led to the diagnosis of myasthenia gravis (MG) in previously undiagnosed individuals. In the pilot, two assessment tools were developed by the study team: the Impact of Daily Living (IDL) Survey and the MG Physical Tests. 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 patients with MG.

The pilot enrolled a small cohort of participants. This current study is expanding the targeted sample size and enrollment period with the goal of validating the self-assessment tool.

Participants with undiagnosed neuromuscular symptoms, recruited through targeted social media advertisements, will complete enrollment on our study webpage.(www.unearthrootcause.com). Consented adults without specific diagnosed neurological conditions will first be screened using the IDL survey, which assesses the presence/absence of characteristic MG symptoms and habits. Qualified participants will then complete the MG Physical Tests, following video-guided instructions to perform 10 physical tests evaluating inducible muscle fatigue. A neurologist will asynchronously review the assessment results to determine whether an in-person neurology evaluation for MG is warranted. Each participant will receive a report of the neurologist's evaluation and study results to present to their doctor. Participants will be followed for up to six months with monthly survey check-ins to track whether they sought clinical evaluation and received a confirmed MG diagnosis. During follow-up participants who self-report as MG positive (newly diagnosed MG) or MG negative (MG was ruled out by physician or through testing) will be asked to upload confirmatory medical records or undergo an interview with a study navigator.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ananda Vishnu Pandurangadu, MD; Phone Number: 1-847-448-1001; Email: support@unearthrootcause.com

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • ZS Associates
      • Sub-Investigator: Pritikanta Paul, MD
      • Contact: Ananda V Pandurangadu, MD; Phone Number: 847-448-1001; Email: support@unearthrootcause.com
      • Principal Investigator: Ananda V Pandurangadu, MD

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, including sero-negative MG*
• 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
Self-Assessment tool validity	Measure the specificity and sensitivity of the Self-Assessment tool	6 months from time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social media engagement	Measure the engagement and cost metrics of the social media ad campaign	Enrollment period (~4-5 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnosis	Evaluate the time to diagnosis for any participant who has a new diagnosis of MG after completing the study	6 months from time of enrollment

Collaborators and Investigators

• Sponsor: ZS Associates
• Collaborators: UCB Pharma; University of California, San Francisco

Publications and helpful links

Helpful Links

• Study enrollment webpage

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 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-002

Drug and device information, study documents

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