NCT02078050

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 12, 2017

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

December 20, 2013

Last Update Submit

January 11, 2017

Conditions

Neuromuscular DiseasesRespiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Study Arms (1)

Phrenic nerves magnetic stimulations

OTHER
Other: Phrenic nerves magnetic stimulations

Interventions

Phrenic nerves magnetic stimulationsOTHER
Phrenic nerves magnetic stimulations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and more men or women
  • neuromuscular diseases
  • Pimax and Snip 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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

March 5, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 12, 2017

Record last verified: 2016-02

Locations

FR(1)