Myasthenia GravisNCT06866483
Validation and Scaling of Screening Program for Undiagnosed Myasthenia Gravis-Social Media Campaign Paired With a Self-moderated Assessment
An observational study of Myasthenia Gravis and Neuromuscular Disease, run by ZS Associates at 1 site in United States.
Trial summary
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. 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 Disease, Neuromuscular Manifestations
- What is being tested?
- Social media recruitment, Self-Assessment and Follow-up
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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, including sero-negative MG*
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ZS Associates
Evanston, Illinois, 60201
Ananda V Pandurangadu, MD, 847-448-1001, support@unearthrootcause.com
Ananda V Pandurangadu, MD
About this study
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).
Read the 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.
- Being tested
- Social media recruitment, Self-Assessment, Follow-up
- Keywords
- social media, myasthenia gravis
- Medical subject headings
- Myasthenia Gravis, Neuromuscular Diseases, Neuromuscular Manifestations
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.
Self-Assessment tool validity
Measure the specificity and sensitivity of the Self-Assessment tool
Measured: 6 months from time of enrollment
Secondary outcomes (1)
Social media engagement
Measure the engagement and cost metrics of the social media ad campaign
Measured: Enrollment period (~4-5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start26 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 1,000 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866483
- Sponsor's protocol ID
- MG-002
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Scaling of Screening Program for Undiagnosed Myasthenia Gravis-Social Media Campaign Paired With a Self-moderated Assessment
- ClinicalTrials.gov ID
- NCT06866483
- Acronym / sponsor ID
- MG-002
- Keywords
- social media, myasthenia gravis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ZS AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- UCB Pharma, University of California, San Francisco
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2025 (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 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.
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, including sero-negative MG*
- 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
Self-Assessment tool validity
Time frame: 6 months from time of enrollment
Measure the specificity and sensitivity of the Self-Assessment tool
1 secondary outcome
Social media engagement
Time frame: Enrollment period (~4-5 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Study enrollment webpageLink 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.
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 Disease, 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: looking for participants now, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ananda Vishnu Pandurangadu, MD (1-847-448-1001, support@unearthrootcause.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Assessment tool validity (time frame: 6 months from time of enrollment). 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 10 Mar 2025.