Bulbar Function in Neuromuscular Patients (ORDEG)
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ClinicalTrials.gov Identifier: NCT02097368 |
Recruitment Status
:
Recruiting
First Posted
: March 27, 2014
Last Update Posted
: January 25, 2018
|
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Condition or disease | Intervention/treatment |
---|---|
Neuromuscular Diseases | Procedure: tongue strength measurement Procedure: respiratory function measurement Procedure: swallowing tests Other: Magnetic resonance imaging |
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:
- to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
- 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 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 |

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
|
- Change of tongue strength measurement [ Time Frame: 5 years ]Measurement using mechanical force transducer
- swallowing tests [ Time Frame: 5 years ]Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography
- Respiratory parameters [ Time Frame: 5 years ]Vital capacity and respiratory muscle strength measurement using spirometry and manometry
- Vital capacity [ Time Frame: 5 years ]Spirometry
- Respiratory muscle strength [ Time Frame: 5 years ]manometry (maximal inspiratory pressure and expiratory pressure)

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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 |
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

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