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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with undiagnosed neuromuscular symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social media recruitment | Behavioral | Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Assessment tool validity | Measure the specificity and sensitivity of the Self-Assessment tool | 6 months from time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Social media engagement | Measure the engagement and cost metrics of the social media ad campaign | Enrollment period (~4-5 months) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Adult participants who have undiagnosed neuromuscular symptoms
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ananda Vishnu Pandurangadu, MD | Contact | 1-847-448-1001 | support@unearthrootcause.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZS Associates | Recruiting | Evanston | Illinois | 60201 | United States |
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| Label | URL |
|---|---|
| Study enrollment webpage | View source |
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| Self-Assessment | Behavioral | Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups |
|
| 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 |
|
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D009468 | Neuromuscular Diseases |
| D020879 | Neuromuscular Manifestations |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059026 | Diagnostic Self Evaluation |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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