NCT07823101 · Johns Hopkins University
Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Bulbar Muscle Thickness Assessed by Neuromuscular Ultrasound
Time frame: Day 1 (one-time study visit)
Bulbar muscle thickness will be measured using B-mode neuromuscular ultrasound in short- and long-axis views.
Bulbar Muscle Cross-Sectional Area Assessed by Neuromuscular Ultrasound
Time frame: Day 1 (one-time study visit)
Cross-sectional area of the assessed bulbar muscles will be measured using neuromuscular ultrasound.
Bulbar Muscle Echogenicity Assessed by Quantitative Grayscale Ultrasound
Time frame: Day 1 (one-time study visit)
Bulbar muscle echogenicity will be evaluated using quantitative grayscale analysis of neuromuscular ultrasound images.
Bulbar Muscle Echogenicity Assessed by the Heckmatt Grading Scale
Time frame: Day 1 (one-time study visit)
Bulbar muscle echogenicity will be assessed using the Heckmatt grading scale on neuromuscular ultrasound images. Scale 1-4, lower score better.
Bulbar Muscle Volume Assessed by Magnetic Resonance Imaging
Time frame: Day 1 (one-time study visit)
Bulbar muscle volume will be measured from magnetic resonance imaging and reported in cubic centimeters (cm³).
Bulbar Muscle Cross-Sectional Area Assessed by Magnetic Resonance Imaging
Time frame: Day 1 (one-time study visit)
Bulbar muscle cross-sectional area will be measured from magnetic resonance imaging and reported in square centimeters (cm²).
Bulbar Muscle Fat Content Assessed by Magnetic Resonance Imaging
Time frame: Day 1 (one-time study visit)
Bulbar muscle fat content will be measured using magnetic resonance imaging and reported as a percentage (%).
Tongue Muscle Stiffness Assessed by Ultrasound Elastography
Time frame: Day 1 (one-time study visit)
Tongue muscle stiffness will be quantitatively assessed using shear-wave ultrasound elastography.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2026 · Source of record for eligibility and locations