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Can advanced imaging reveal hidden swallowing muscle damage in IBM?

NCT ID NCT07823101

Diagnosis Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at Johns Hopkins University are studying whether neuromuscular ultrasound and MRI can serve as reliable markers of swallowing muscle problems in people with inclusion body myositis (IBM). The study compares imaging and clinical findings in 30 participants, including people with IBM, other myopathies, ALS, PLS, and healthy volunteers. Participants attend a single visit for neurological assessments, swallowing questionnaires, tongue strength testing, and imaging scans. The goal is to find more sensitive and objective ways to measure bulbar muscle changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neuromuscular ultrasound and MRI imaging
What this could lead to
If the imaging markers prove reliable, doctors could one day detect swallowing muscle damage earlier and track it more objectively in people with IBM and similar conditions.
What could go wrong
This is a small, single-visit study with 30 participants, so it can only show whether the imaging measures look promising. It cannot prove they improve patient care, and results may not apply to everyone with these diseases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Asthenia inclusion body myositis juvenile dermatomyositis lateral sclerosis muscle tissue disorder myopathy myositis disease Papillon-Lefevre disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS (amyotrophic lateral sclerosis) IBM Inclusion body myositis Myopathy Myositis PLS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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