Early access
Sign in
Taking people in United StatesNo phase

Imaging swallowing and speech muscles in people with inclusion body myositis

Tests ultrasound and MRI to assess swallowing muscles in adults with inclusion body myositis.

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Registry title
Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis
Status
Recruiting
People taking part
30 people, planned
Started
Nov 2026
Expected to end
31 Dec 2027
Type of study
Observational, 4 groups
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with inclusion body myositis (IBM), other myopathies, ALS or PLS, and healthy volunteers. It uses ultrasound and MRI to study swallowing and speech muscles.

Age
18 years or older
Sex
All sexes can join.
Disease stage
A confirmed diagnosis of inclusion body myositis (IBM), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS) or myopathy. Healthy controls must have no neuromuscular disease.
Earlier treatment
People who have had a procedure for swallowing problems (dysphagia), such as myotomy, dilatation or Botox, cannot join.
Biomarker or test result
People with a disease need lab tests for disease markers (for example CK, CMP, CBC) done within the last 12 months.

Main reasons for not taking part

  • Cannot lie flat on the back for 30 minutes or longer
  • Significant breathing difficulties
  • Another known neuromuscular condition with bulbar involvement (for people with IBM, ALS or myopathy)
  • Had a procedure for dysphagia, such as myotomy, dilatation or Botox
  • Unable or unwilling to give written informed consent

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with IBM, ALS, or myopathy who have another known neuromuscular condition with known bulbar involvement
  • 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
  • Unable or unwilling to provide written informed consent
  • 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
  • Any patient who has undergone a procedure for dysphagia, including myotomy, dilatation, or Botox

Where in United States

  • The Johns Hopkins HospitalBaltimore, United StatesContact: Abdullah AlQahtani, MD MPHTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Inclusion Body Myositis

    Participants with diagnosis of IBM

  • Inflammatory or Genetic Myopathies

    other types of myopathy that is not IBM

  • Motor neuron disease(ALS/PLS)

    Participants must have spastic dysarthria

  • Healthy controls

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Advancing Bulbar Assessment in Inclusion Body Myositis Through a Multimodal Imaging Approach
Plain-language title
Imaging swallowing and speech muscles in people with inclusion body myositisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
28 October 2026