Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Bulbar Function in Neuromuscular Patients (ORDEG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02097368
First received: December 20, 2013
Last updated: July 21, 2014
Last verified: July 2014
History of Changes
  Purpose

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 Intervention
Neuromuscular Diseases
 Procedure: tongue strength measurement
Procedure: respiratory function measurement
Procedure: swallowing tests
Other: Magnetic resonance imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of Bulbar Function in Neuromuscular Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Change of tongue strength measurement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Measurement using mechanical force transducer


Secondary Outcome Measures:
  • swallowing tests [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography

  • Respiratory parameters [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Vital capacity and respiratory muscle strength measurement using spirometry and manometry

  • Vital capacity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Spirometry

  • Respiratory muscle strength [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    manometry (maximal inspiratory pressure and expiratory pressure)
Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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) 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

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 18
  • Hospitalization in Home Ventilation Unit of the intensive care department of R POINCARE Hospital
  • Written informed consent

Exclusion Criteria:

  • patient's refusal to participate
  • major swallowing disfunction
  • Acute respiratory failure
  • no affiliation to social security
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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         
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

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02097368     History of Changes
Other Study ID Numbers: 2013-A00601-44
Study First Received: December 20, 2013
Last Updated: July 21, 2014
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

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

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015