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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
| University of California, San Francisco | OTHER |
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This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG).
Participants with undiagnosed neuromuscular symptoms will be targeted via social media paid advertisements to recruit them to our study landing page (weblink: https://bit.ly/unearthrootcause). Two assessment tools were developed by the study team: the Impact of Daily Living (IDL) Survey and the MG Exercise Assessment. 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 MG patients.
Adult participants who don't have specific diagnosed neurologic conditions will first be screened for eligibility based on the results of the IDL survey which will query participants on the presence or absence of habits/symptoms characteristic of MG. Those who qualify will complete the MG Exercise Assessment in which participants are provided video instructions to perform a series of 10 physical tests to examine if specific muscle groups undergo inducible fatigue. The results of the MG Exercise Assessment are reviewed by a neurologist to determine if participants would benefit further from an in-person neurologist evaluation for MG by a provider. Each participant is provided with a report of the neurologist's evaluation. Participants will be followed for 1 year through bimonthly communications to determine if and when they followed up with a clinician and if they received a confirmed diagnosis of myasthenia gravis.
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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 |
|---|---|---|
| Social media recruitment feasibility | Measure the engagement and feasibility metrics of the social media campaign | Enrollment period (4-6weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| MG Exercise Assessment Tool validity | Estimate preliminary measures of validity for the MG Exercise Assessment Tool | 1 year from time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to diagnosis | Evaluate the time to diagnosis for any participant who has a confirmed diagnosis of MG after the completion of the study compared to that reported in literature | 1 year from time of enrollment |
Inclusion Criteria:
Exclusion Criteria:
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Adult participants who have undiagnosed neuromuscular symptoms
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| Name | Affiliation | Role |
|---|---|---|
| Ananda Vishnu Pandurangadu, MD | ZS Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZS Associates | Evanston | Illinois | 60201 | United States |
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| Label | URL |
|---|---|
| Study landing page | 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 |
| D020879 | Neuromuscular Manifestations |
| D009468 | Neuromuscular Diseases |
| 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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