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Clinical Trials/NCT04045158
NCT04045158
Unknown
Not Applicable

Diaphragm Ultrasound in Neuromuscular Disorders

Centre d'Investigation Clinique et Technologique 8051 site in 1 country1,000 target enrollmentMay 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscular Dystrophies
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
1000
Locations
1
Primary Endpoint
diaphragm ultrasound motion
Last Updated
6 years ago

Overview

Brief Summary

Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.

The aims of the study are:

  • to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies
  • to assess the correlation between diaphragm ultrasound and FPT
  • to assess the correlation between diaphragm ultrasound and cardiac function
Registry
clinicaltrials.gov
Start Date
May 15, 2019
End Date
May 10, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Principal Investigator
Principal Investigator

Abdallah FAYSSOIL

MD PhD

Centre d'Investigation Clinique et Technologique 805

Eligibility Criteria

Inclusion Criteria

  • Duchenne muscular dystrophy,
  • Becker muscular dystrophy,
  • myotonic dystrophy type 1 and type 2,
  • metabolic myopathy,
  • mitochondrial myopathy,
  • FSHD1 and 2,
  • myasthenia

Exclusion Criteria

  • history of cardiac surgery
  • history of thoracic surgery
  • brain traumatism

Outcomes

Primary Outcomes

diaphragm ultrasound motion

Time Frame: 1 year

using echography

Secondary Outcomes

  • correlation between diaphragm motion (mm) and forced vital capacity(ml)(1 year)
  • correlation between diaphragm motion (mm) and inspiratory capacity (ml)(1 year)
  • diaphragm thickness (mm)(1 year)
  • correlation between diaphargm thickness and maximal inspiratory pressure (cmH20)(1 year)

Study Sites (1)

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