An observational study in Myasthenia Gravis, Neuromuscular Disease and Neuromuscular Manifestations, sponsored by ZS Associates. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by ZS Associates · Observational
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).
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.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 130 across 105 observational studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →ZS Associates is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult participants who have undiagnosed neuromuscular symptoms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Social media recruitment · Behavioral: Self-Assessment · Behavioral: Follow-up
Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment
Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups
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
Self-Assessment tool validity
Measure the specificity and sensitivity of the Self-Assessment tool
Time frame: 6 months from time of enrollment
Social media engagement
Measure the engagement and cost metrics of the social media ad campaign
Time frame: Enrollment period (~4-5 months)
Time to diagnosis
Evaluate the time to diagnosis for any participant who has a new diagnosis of MG after completing the study
Time frame: 6 months from time of enrollment
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