Diaphragm Ultrasound in Neuromuscular Disorders

August 2, 2019 updated by: Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with neuromuscular diseases admitted for a cardio-respiratory function evaluation

Description

Inclusion Criteria:

  • Duchenne muscular dystrophy,
  • Becker muscular dystrophy,
  • LGMD,
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragm ultrasound motion
Time Frame: 1 year
using echography
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between diaphragm motion (mm) and forced vital capacity(ml)
Time Frame: 1 year
using echography and FPT
1 year
correlation between diaphragm motion (mm) and inspiratory capacity (ml)
Time Frame: 1 year
using echography and FPT
1 year
diaphragm thickness (mm)
Time Frame: 1 year
using echography
1 year
correlation between diaphargm thickness and maximal inspiratory pressure (cmH20)
Time Frame: 1 year
using echography and FPT
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Anticipated)

December 28, 2019

Study Completion (Anticipated)

May 10, 2020

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAPH-NMD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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