RecruitingNCT07823101

Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis

Advancing Bulbar Assessment in Inclusion Body Myositis Through a Multimodal Imaging Approach

Sponsor

Johns Hopkins University

Enrollment

30 participants

Start Date

Oct 1, 2026

Study Type

OBSERVATIONAL

Conditions

Inclusion Body Myositis ALS (Amyotrophic Lateral Sclerosis)Myositis IBM PLS Myopathy

Summary

This study will evaluate whether neuromuscular ultrasound and MRI can be used as imaging markers of bulbar involvement and swallowing dysfunction in individuals with inclusion body myositis (IBM). Researchers will compare imaging and clinical findings in participants with IBM with those in participants with other myopathies, ALS, PLS, and healthy volunteers. The study is a one-time visit. Study procedures may include neurological assessments, swallowing questionnaires, tongue strength testing, neuromuscular ultrasound, and MRI. The goal is to identify more sensitive and objective ways to assess bulbar dysfunction biomarkers.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Participants must have a confirmed diagnosis of inclusion body myositis (IBM), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), or myopathy in accordance with the respective diagnostic criteria.
Participants with disease must have clinically relevant laboratory testing for disease biomarkers (e.g., Creatine Kinase (CK), Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC)) within the last 12 months.
Participants must be able to remain supine for 30 minutes or longer and cannot have significant breathing difficulties.
Healthy controls must not have any neuromuscular disease.

Exclusion Criteria5

Unable or unwilling to provide written informed consent.
Medical history or clinically significant physical examination or laboratory results that, in the opinion of the investigator, would render the participant unsuitable for the study.
Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
Patients with IBM, ALS, or myopathy who have another known neuromuscular condition with known bulbar involvement.
Any patient who has undergone a procedure for dysphagia, including myotomy, dilatation, or Botox.

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