Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT07823101

Conditions

IBM

Inclusion Body Myositis

Myopathy

Myositis

ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

IBM

Inclusion Body Myositis

Myopathy

Myositis

ALS (Amyotrophic Lateral Sclerosis)

Study ID

NCT07823101

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Bulbar Muscle Thickness Assessed by Neuromuscular Ultrasound [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Cross-Sectional Area Assessed by Neuromuscular Ultrasound [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Echogenicity Assessed by Quantitative Grayscale Ultrasound [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Echogenicity Assessed by the Heckmatt Grading Scale [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Volume Assessed by Magnetic Resonance Imaging [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Cross-Sectional Area Assessed by Magnetic Resonance Imaging [ Time Frame: Day 1 (one-time study visit) ]
  • Bulbar Muscle Fat Content Assessed by Magnetic Resonance Imaging [ Time Frame: Day 1 (one-time study visit) ]
  • Tongue Muscle Stiffness Assessed by Ultrasound Elastography [ Time Frame: Day 1 (one-time study visit) ]

Central Contacts and Locations

Central contacts

Joseph D Niang, B.A.

410-570-3949jniang1@jh.edu

Pamela Arrazola, M.S.

410-955-0749parrazo1@jh.edu

Locations

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Abdullah AlQahtani, MD MPH

443-819-9480aalqaht3@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • swallowing
  • tongue weakness
  • bulbar weakness
  • weakness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.