Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

January 11, 2017 updated by: Centre d'Investigation Clinique et Technologique 805
Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately, volitional maneuvers depend of patient effort. The aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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 R. 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old and more men or women
  • neuromuscular diseases
  • Pimax and Snip evaluation Indication

Exclusion Criteria:

  • pregnant women
  • Usual contre-indications for nuclear magnetic resonance

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Phrenic nerves magnetic stimulations
Other: Phrenic nerves magnetic stimulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetic stimulation pressure measure (Pstim), according to 3 conditions : Pstime, Pstim-5 and Pstim-1 (measured in cmH20). The condition which is most correlated with maximal inspiratory pressure (Pimax or Psnip) is selected.
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

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

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

March 3, 2014

First Posted (ESTIMATE)

March 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00638-37

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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