Myasthenia GravisNCT06381284
Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
An observational study of Myasthenia Gravis and Neuromuscular Manifestations, run by ZS Associates at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis, Neuromuscular Manifestations, Neuromuscular Diseases
- What is being tested?
- Social media recruitment, Self-Assessment and Follow-up
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 3 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants who have undiagnosed neuromuscular symptoms
Who may be able to join
- 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
Who cannot join
- Live in an overseas territory of the United States
- Inability or unwillingness to provide written informed consent
- Diagnosed myasthenia gravis
- Diagnosed multiple sclerosis
- Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Being tested
- Social media recruitment, Self-Assessment, Follow-up
- Keywords
- Social Media, Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis, Neuromuscular Manifestations, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social media recruitmentBehavioural
Social media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment
Self-AssessmentBehavioural
Eligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups
Follow-upBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Participants with undiagnosed neuromuscular symptoms | Not described Receives: Behavioral: Social media recruitment; Behavioral: Self-Assessment; Behavioral: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social media recruitment feasibility
Measure the engagement and feasibility metrics of the social media campaign
Measured: Enrollment period (4-6weeks)
Secondary outcomes (1)
MG Exercise Assessment Tool validity
Estimate preliminary measures of validity for the MG Exercise Assessment Tool
Measured: 1 year from time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start28 Mar 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZS Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Pharma, University of California, San Francisco
- Responsible party
- Principal investigator, Ananda Vishnu Pandurangadu, MD, ZS Associates
- Investigators
- Ananda Vishnu Pandurangadu, MD, Principal investigator, ZS Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381284
- Sponsor's protocol ID
- MG-001
- Status last verified
- Mar 2025
- First submitted
- 18 Apr 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
- ClinicalTrials.gov ID
- NCT06381284
- Acronym / sponsor ID
- MG-001
- Keywords
- Social Media, Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- ZS AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- UCB Pharma, University of California, San Francisco
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with undiagnosed neuromuscular symptoms | – | Behavioral: Social media recruitment, Behavioral: Self-Assessment, Behavioral: Follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants who have undiagnosed neuromuscular symptoms
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Live in an overseas territory of the United States
- Inability or unwillingness to provide written informed consent
- Diagnosed myasthenia gravis
- Diagnosed multiple sclerosis
- Have speech impairment, eye/arm/leg weakness due to diagnosed brain cancer, or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social media recruitmentSocial media users exposed to a variety of paid social media advertisements as a recruitment tool for study enrollment | Behavioural | Participants with undiagnosed neuromuscular symptoms |
| Self-AssessmentEligible participants are asked to complete self-administered physical tests to assess inducible fatigue of specific muscle groups | Behavioural | Participants with undiagnosed neuromuscular symptoms |
| Follow-upPatients triaged based on their assessed risk of MG are asked to complete recommended follow-up with a clinician to determine presence of myasthenia gravis | Behavioural | Participants with undiagnosed neuromuscular symptoms |
Primary outcome
Social media recruitment feasibility
Time frame: Enrollment period (4-6weeks)
Measure the engagement and feasibility metrics of the social media campaign
1 secondary outcome
MG Exercise Assessment Tool validity
Time frame: 1 year from time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Study landing pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ananda Vishnu Pandurangadu, MD principal investigator
ZS Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis and Neuromuscular Manifestations, run by ZS Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social media recruitment feasibility (time frame: Enrollment period (4-6weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.