Validation and Scaling of Screening Program for Undiagnosed Myasthenia Gravis-Social Media Campaign Paired With a Self-moderated Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Social media recruitment, Self-Assessment, Follow-up.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, Neuromuscular Disease, Neuromuscular Manifestations. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
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.
Interventions
- 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
Primary outcome measures
- Self-Assessment tool validity [Time frame: 6 months from time of enrollment]
Secondary outcome measures (1)
- Social media engagement [Time frame: Enrollment period (~4-5 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- ZS Associates — Evanston
Identifiers
NCT: NCT06866483 · MG-002