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Recruiting NCT07146256

Natural History of Oculo-Pharyngeal Muscular Dystrophy (OPMD) - Israel National OPMD Registry

Observational Oculopharyngeal Muscular Dystrophy (OPMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-interventional observational study.
Who it may be relevant to
Registry conditions: Oculopharyngeal Muscular Dystrophy (OPMD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this open prospective multi-disciplinary observational study of patients with OPMD at various stages of clinical manifestations is to explore the natural history of the disease in the Israeli population.

Detailed description

The the following procedures will be performed by a multidisciplinary team:

Neurological and neurocognitive examination; Clinical assessment of of swallowing and severity of dysphagia; Clinical assessment of eyelid ptosis severity; Clinical assessment of respiratory muscles function; Clinical assessment of oral health

Interventions

  • Other Non-interventional observational study
    No intervention will be studied

Primary outcome measures

  • Severity of muscle strength decline over time [Time frame: 1 year]
  • Penetration/Aspiration Scale [Time frame: 1 year]
  • Upper Margin Reflex Distance [Time frame: 1 year]
  • Lower Margin Reflex Distance [Time frame: 1 year]
Secondary outcome measures (6)
  • Maximum Expiratory Pressure [Time frame: 2 years]
  • Cough Peak Flow [Time frame: 2 years]
  • Oral health [Time frame: 2 years]
  • Dysphagia severity [Time frame: 1 year]
  • Functional Oral Intake Scale [Time frame: 1 year]
  • Swallowing Disturbance [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Patients with clinical diagnosis of OPMD or patients with signs /symptoms suggestive of OPMD

Exclusion criteria

  • Age <18 years and Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Israel · 1 center
  • Sheba Medical Center — Ramat Gan

Identifiers

NCT: NCT07146256 · SHEBA-21-8801-AD-CTIL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗