An observational study in IBM, Inclusion Body Myositis and Myopathy, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Johns Hopkins University · Observational
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.
Researchers will evaluate ultrasound and Magnetic Resonance Imaging (MRI) as imaging markers to diagnose bulbar involvement and dysphagia in patients with IBM.
Objectives
Primary Objectives:
Secondary Objectives:
65 studies on the registry are indexed under Myositis, Inclusion Body; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 81 across 20 observational studies indexed under Myositis, Inclusion Body.
Browse Myositis, Inclusion Body studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include approximately 30 participants with inclusion body myositis (IBM), amyotrophic lateral sclerosis (ALS), or primary lateral sclerosis (PLS); non-IBM inflammatory or genetic myopathies; and healthy controls. The planned enrollment includes 10 participants with IBM and swallowing difficulties, 5 participants with IBM without swallowing difficulties, 5 participants with non-IBM inflammatory or genetic myopathies, 5 participants with bulbar ALS, and 5 healthy controls. The investigators will recruit patients primarily through the clinical practices of the principal investigator and co-investigators and through referrals. Healthy controls may be recruited from Johns Hopkins University/Johns Hopkins Hospital staff, Johns Hopkins affiliates, and family members of patients and staff. The participants will be screened to exclude pre-existing neuromuscular disorders. Healthy controls will be age-matched to the IBM cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with diagnosis of IBM
other types of myopathy that is not IBM
Participants must have spastic dysarthria
Bulbar Muscle Thickness Assessed by Neuromuscular Ultrasound
Bulbar muscle thickness will be measured using B-mode neuromuscular ultrasound in short- and long-axis views.
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Cross-Sectional Area Assessed by Neuromuscular Ultrasound
Cross-sectional area of the assessed bulbar muscles will be measured using neuromuscular ultrasound.
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Echogenicity Assessed by Quantitative Grayscale Ultrasound
Bulbar muscle echogenicity will be evaluated using quantitative grayscale analysis of neuromuscular ultrasound images.
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Echogenicity Assessed by the Heckmatt Grading Scale
Bulbar muscle echogenicity will be assessed using the Heckmatt grading scale on neuromuscular ultrasound images. Scale 1-4, lower score better.
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Volume Assessed by Magnetic Resonance Imaging
Bulbar muscle volume will be measured from magnetic resonance imaging and reported in cubic centimeters (cm³).
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Cross-Sectional Area Assessed by Magnetic Resonance Imaging
Bulbar muscle cross-sectional area will be measured from magnetic resonance imaging and reported in square centimeters (cm²).
Time frame: Day 1 (one-time study visit)
Bulbar Muscle Fat Content Assessed by Magnetic Resonance Imaging
Bulbar muscle fat content will be measured using magnetic resonance imaging and reported as a percentage (%).
Time frame: Day 1 (one-time study visit)
Tongue Muscle Stiffness Assessed by Ultrasound Elastography
Tongue muscle stiffness will be quantitatively assessed using shear-wave ultrasound elastography.
Time frame: Day 1 (one-time study visit)
Center for Neurologic Study Bulbar Function Scale Score
Bulbar function will be assessed using the Center for Neurologic Study Bulbar Function Scale (CNS-BFS), a 21-item patient-reported questionnaire evaluating speech, swallowing, and salivation. Score ranging from 21 to 112, where a score of 21 indicates no symptoms of bulbar dysfunction.
Time frame: Day 1 (one-time study visit)
Neuromuscular Disease Swallowing Status Scale Score
Swallowing function will be assessed using the Neuromuscular Disease Swallowing Status Scale (NdSSS), an 8-stage clinician-rated scale ranging from normal oral intake to complete dependence on non-oral feeding. Stage 8 represents normal function, while Stage 1 represents the most severe impairment.
Time frame: Day 1 (one-time study visit)
Eating Assessment Tool-10 Score
Dysphagia symptoms and the symptoms impact on quality of life will be assessed using the 10-item Eating Assessment Tool (EAT-10). Total score ranges from 0 to 40, with a score of 3 or higher indicating a potential swallowing problem.
Time frame: Day 1 (one-time study visit)
Sydney Swallow Questionnaire Score
Severity of oropharyngeal dysphagia symptoms will be assessed using the 17-item Sydney Swallow Questionnaire (SSQ). Score range 0 to 1,700, with higher scores indicating more severe swallowing problem.
Time frame: Day 1 (one-time study visit)
Maximum Tongue Strength Assessed by the Iowa Oral Performance Instrument
Maximum tongue strength will be measured using the Iowa Oral Performance Instrument (IOPI). Three trials will be performed, and the highest pressure will be recorded in kilopascals (kPa).
Time frame: Day 1 (one-time study visit)
Tongue Endurance Assessed by the Iowa Oral Performance Instrument
Tongue endurance will be measured using the Iowa Oral Performance Instrument (IOPI) as the amount of time, in seconds, the participant can maintain 50% of their maximum tongue pressure.
Time frame: Day 1 (one-time study visit)
Inclusion Body Myositis Functional Rating Scale Score
Functional status in participants with inclusion body myositis will be assessed using the Inclusion Body Myositis Functional Rating Scale (IBMFRS), including swallowing-related function. Score ranges from 0 to 40, higher score better.
Time frame: Day 1 (one-time study visit)
Amyotrophic Lateral Sclerosis Functional Rating Scale Score
Functional disability and disease severity in participants with amyotrophic lateral sclerosis will be assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS). Score ranges from 0 (maximum disability/worst performance) to 48 (normal function).
Time frame: Day 1 (one-time study visit)
Plan to share: No
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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