Diaphragm Ultrasound in Neuromuscular Disorders

Muscular Dystrophies Clinical Trial

Official title:

Diaphragm Ultrasound in Neuromuscular Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04045158
• Other study ID #: DIAPH-NMD
• Status: Active, not recruiting
• Start date: May 15, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: August 2019
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 10, 2020
• Est. primary completion date: December 28, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Neuromuscular Diseases

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diaphragm ultrasound motion	using echography	1 year
Secondary	correlation between diaphragm motion (mm) and forced vital capacity(ml)	using echography and FPT	1 year
Secondary	correlation between diaphragm motion (mm) and inspiratory capacity (ml)	using echography and FPT	1 year
Secondary	diaphragm thickness (mm)	using echography	1 year
Secondary	correlation between diaphargm thickness and maximal inspiratory pressure (cmH20)	using echography and FPT	1 year