Feasibility of Engaging & Capturing Undiagnosed Myasthenia Gravis

Status Recruiting

Clinical 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 and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06381284
Study type	Observational
Source	ZS Associates
Contact	Ananda V Pandurangadu, MD
Phone	1-847-448-1001
Email	support@unearthrootcause.com
Status	Recruiting
Phase
Start date	March 28, 2024
Completion date	May 27, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT04435093` - Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Completed	`NCT01313325` - Hippotherapy to Improve the Balance of Children With Movement Disorders	N/A
Recruiting	`NCT04098094` - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Active, not recruiting	`NCT05070624` - The Peer Support Study	N/A
Completed	`NCT04729920` - Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
Recruiting	`NCT04581577` - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Enrolling by invitation	`NCT05539456` - Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Completed	`NCT05353738` - Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
Recruiting	`NCT04541602` - Detection of Neuromuscular Complications in Critically Ill Patients
Completed	`NCT03394859` - Electronic Medical Records and Genomics (eMERGE) Phase III
Enrolling by invitation	`NCT05099107` - Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment	N/A
Completed	`NCT05070910` - NDT Effectiveness Study	N/A
Recruiting	`NCT04100993` - Multisystem and Autonomic Complications of NMD on Long-term NIV
Not yet recruiting	`NCT05785546` - Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System
Recruiting	`NCT04986059` - Effects of Pre-event Massage on Muscle Activity	N/A
Completed	`NCT01022931` - Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva	N/A
Terminated	`NCT03353064` - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure	N/A
Recruiting	`NCT05318638` - Soft-robotic Glove Support of High-demand Tasks	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms