ClinicalTrials.gov
ClinicalTrials.gov Menu

Bulbar Function in Neuromuscular Patients (ORDEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02097368
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

Condition or disease Intervention/treatment
Neuromuscular Diseases Procedure: tongue strength measurement Procedure: respiratory function measurement Procedure: swallowing tests Other: Magnetic resonance imaging

Detailed Description:

The main objective is to study the function of the superior airways (tongue and pharynx) in an non invasive way in neuromuscular patients followed in the home ventilation unit of the Raymond POINCARE hospital (myopathy, neuropathy, disease of the neuromuscular junction or anterior horn) or of Necker Hospital and to detect prematurely the bulbar dysfunction.

The secondary objectives of this prospective monocentric observational physiopathological study are:

  1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
  2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.

The maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.

Swallowing will be estimated by a non invasive method already used to highlight swallowing disorders in neurological and muscular pathologies This method will be associated with a method of recording of thoracic and abdominal movements.

Data wil be compared to a control database obtained for a previous study


Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Evaluation of Bulbar Function in Neuromuscular Patients
Study Start Date : April 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
neuromuscular patient
Patients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging
 Procedure: tongue strength measurement
tongue strength measurement
Procedure: respiratory function measurement
respiratory function measurement
Procedure: swallowing tests
swallowing tests
Other: Magnetic resonance imaging
Magnetic resonance imaging


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change of tongue strength measurement [ Time Frame: 5 years ]
    Measurement using mechanical force transducer


Secondary Outcome Measures :
  1. swallowing tests [ Time Frame: 5 years ]
    Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography

  2. Respiratory parameters [ Time Frame: 5 years ]
    Vital capacity and respiratory muscle strength measurement using spirometry and manometry

  3. Vital capacity [ Time Frame: 5 years ]
    Spirometry

  4. Respiratory muscle strength [ Time Frame: 5 years ]
    manometry (maximal inspiratory pressure and expiratory pressure)


Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients affected by neuromuscular pathology
Criteria

Inclusion Criteria:

  • neuromuscular disorder
  • age greater than or equal to 6
  • Hospitalization in Home Ventilation Unit - Written informed consent

Exclusion Criteria:

  • patient's refusal to participate
  • major swallowing disfunction
  • Acute respiratory failure
  • no affiliation to social security
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097368


Contacts
Contact: David Orlikowski, MD PhD 33147107777 david.orlikowski@rpc.aphp.fr
Contact: Frederic Barbot, MD 33147104474 frederic.barbot@rpc.aphp.fr

Locations
France
Home Ventilation Unit, Raymond Poincare Hospital Recruiting
Garches, France, 92380
Contact: David Orlikowski, MD, PhD    33 1 47 10 77 77    david.orlikowski@rpc.aphp.fr   
Contact: Marjorie Figere, CRA    33147104615    marjorie.figere@rpc.aphp.fr   
Principal Investigator: David Orlikowski, MD,PhD         
Sub-Investigator: Helene Prigent, MD, PhD         
Sub-Investigator: Frederic Lofaso, MD, PhD         
Non invasive ventilation Unit - Necker Hospital Not yet recruiting
Paris, France, 75015
Contact: David Orlikowski, PHD    0033147107777    david.orlikowski@rpc.aphp.fr   
Sub-Investigator: Brigitte Fauroux, PHD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: David Orlikowski, MD, PhD Centre d'Investigation Clinique et Technologique 805
Principal Investigator: Helene Prigent, MD,PhD Centre d'Investigation Clinique et Technologique 805
Principal Investigator: Frederic Lofaso, MD, PhD Centre d'Investigation Clinique et Technologique 805
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02097368     History of Changes
Other Study ID Numbers: 2013-A00601-44
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Tongue strength
neuromuscular
swallowing

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases