NCT02242162

Brief Summary

Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

6.7 years

First QC Date

September 15, 2014

Last Update Submit

March 1, 2016

Conditions

Neuromuscular DiseasesRespiratory Failure

Keywords

phrenic nerves magnetic stimulations

Outcome Measures

Primary Outcomes (1)

  • magnetic stimulation pressure measure( Pstim)

    phrenic nerves magnetic stimulations

    10 minutes

Study Arms (1)

neuromuscular diseases

Procedure: phrenic nerves magnetic stimulations

Interventions

phrenic nerves magnetic stimulationsPROCEDURE
neuromuscular diseases

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

neuromuscular diseases

You may qualify if:

  • Neuromuscular disease
  • Pimax evaluation indication

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital R Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular DiseasesRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Nervous System DiseasesRespiration DisordersRespiratory Tract Diseases

Study Officials

  • frederic Lofaso, Pr

    Hopital R Poincaré

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 16, 2014

Study Start

May 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

FR(1)