Neuromuscular DiseasesPI MAX STIMNCT02242162
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax
An observational study of Neuromuscular Diseases and Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Neuromuscular Diseases, Respiratory Failure
- What is being tested?
- phrenic nerves magnetic stimulations
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: neuromuscular diseases
Who may be able to join
- Neuromuscular disease
- Pimax evaluation indication
Who cannot join
- pregnant women
- usual contre-indications for nuclear magnetic resonance
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neuromuscular Diseases, Respiratory Failure
- Being tested
- phrenic nerves magnetic stimulations
- Keywords
- phrenic nerves magnetic stimulations
- Medical subject headings
- Neuromuscular Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phrenic nerves magnetic stimulationsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular diseases | Not described Receives: Procedure: phrenic nerves magnetic stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnetic stimulation pressure measure( Pstim)
phrenic nerves magnetic stimulations
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startMay 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- frederic Lofaso, Pr, Principal investigator, Hopital R Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242162
- Sponsor's protocol ID
- 2009-A00630-57
- Acronym
- PI MAX STIM
- Status last verified
- Mar 2016
- First submitted
- 15 Sep 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Non-invasive and Indirect Measure of Volitional Pimax
- ClinicalTrials.gov ID
- NCT02242162
- Acronym / sponsor ID
- PI MAX STIM / 2009-A00630-57
- Conditions
- Neuromuscular Diseases, Respiratory Failure
- Keywords
- phrenic nerves magnetic stimulations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular diseases | – | Procedure: phrenic nerves magnetic stimulations |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neuromuscular diseases
Key inclusion criteria (2 listed)
- Neuromuscular disease
- Pimax evaluation indication
Key exclusion criteria (2 listed)
- pregnant women
- usual contre-indications for nuclear magnetic resonance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phrenic nerves magnetic stimulations | Procedure or surgery | neuromuscular diseases |
Primary outcome
magnetic stimulation pressure measure( Pstim)
Time frame: 10 minutes
phrenic nerves magnetic stimulations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
frederic Lofaso, Pr principal investigator
Hopital R Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnetic stimulation pressure measure( Pstim) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.