Evaluation of dysphagia in inclusion body myositis and oculopharyngeal muscle dystrophy by combining novel ultrasound and real-time MRI

Evaluation of dysphagia in inclusion body myositis and oculopharyngeal muscle dystrophy by combining novel ultrasound and real-time MRI - RT-MRI and ultrasound evaluation of dysphagia in IBM and OPMD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45446

Enrollment

Registered

2017-04-24

Start date

2017-11-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysphagia swallowing disorder

Interventions

diagnosis

dysphagia

inclusion body myositis

oculopharyngeale muscle dystrophy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients diagnosed with IBM based on the ENMC 2011 criteria *clinicopathologically* or *clinically defined* IBM AND patients diagnosed with OPMD - genetic confirmation (PABPN1 mutation present) who can also be participating in the *Projet Stratégique eOPMD: Pathophysiology and therapeutic approaches in Oculopharyngeal Muscular Dystrophy*

Exclusion criteria

Exclusion criteria: presence of diseases that might significantly influence the results of the current study, including: another neuromuscular disorder other than IBM/OPMD, another degenerative disease that might impede swallowing, significant intellectual impairment which impedes the performance of testing; contraindications to undergo MRI-scanning: the presence of metal (including metal splinters in the eye for example), the presence of electronic devices (e.g. a pacemaker), old clipping of cerebral vessels, body weight >140kg; a known pineapple-juice intolerance of allergy.

Design outcomes

Primary

Measure	Time frame
A. to establish the pattern of weakness in a predefined set of muscles in patients with IBM with and without clinical evidence of dysphagia. B. to compare the findings in dysphagic IBM patients with another neuromuscular disease that causes dysphagia: OPMD. C. to evaluate the use of novel diagnostic tools in dysphagia, to develop a diagnostic protocol in neuromuscular diseases to evaluate dysphagia with minimal invasive techniques.	—

Measure

Time frame

A. to establish the pattern of weakness in a predefined set of muscles in patients with IBM with and without clinical evidence of dysphagia. B. to compare the findings in dysphagic IBM patients with another neuromuscular disease that causes dysphagia: OPMD. C. to evaluate the use of novel diagnostic tools in dysphagia, to develop a diagnostic protocol in neuromuscular diseases to evaluate dysphagia with minimal invasive techniques.

—

Secondary

Measure	Time frame
A. to promote international collaboration to expand the existing cohorts of patients affected by these relatively rare diseases. B. the creation of mechanism-based hypothesis on new treatment strategies in dysphagia in IBM and OPMD, which might give rise to a follow-up trial. C. to investigate various outcome measures in IBM with the ultimate goal to find a sensitive, validated and relevant dysphagia outcome measure, with a high sensitivity to change, that can be used in upcoming therapeutic trials.	—

Measure

Time frame

A. to promote international collaboration to expand the existing cohorts of patients affected by these relatively rare diseases. B. the creation of mechanism-based hypothesis on new treatment strategies in dysphagia in IBM and OPMD, which might give rise to a follow-up trial. C. to investigate various outcome measures in IBM with the ultimate goal to find a sensitive, validated and relevant dysphagia outcome measure, with a high sensitivity to change, that can be used in upcoming therapeutic trials.

—

Countries

Germany

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)