Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT02097368
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2013-12-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bulbar Function in Neuromuscular Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of tongue strength measurement', 'timeFrame': '5 years', 'description': 'Measurement using mechanical force transducer'}], 'secondaryOutcomes': [{'measure': 'swallowing tests', 'timeFrame': '5 years', 'description': 'Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography'}, {'measure': 'Respiratory parameters', 'timeFrame': '5 years', 'description': 'Vital capacity and respiratory muscle strength measurement using spirometry and manometry'}, {'measure': 'Vital capacity', 'timeFrame': '5 years', 'description': 'Spirometry'}, {'measure': 'Respiratory muscle strength', 'timeFrame': '5 years', 'description': 'manometry (maximal inspiratory pressure and expiratory pressure)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tongue strength', 'neuromuscular', 'swallowing'], 'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe secondary objectives of this prospective monocentric observational physiopathological study are:\n\n1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters\n2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.\n\nThe maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.\n\nSwallowing 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.\n\nData wil be compared to a control database obtained for a previous study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients affected by neuromuscular pathology', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* neuromuscular disorder\n* age greater than or equal to 6\n* Hospitalization in Home Ventilation Unit - Written informed consent\n\nExclusion Criteria:\n\n* patient's refusal to participate\n* major swallowing disfunction\n* Acute respiratory failure\n* no affiliation to social security"}, 'identificationModule': {'nctId': 'NCT02097368', 'acronym': 'ORDEG', 'briefTitle': 'Bulbar Function in Neuromuscular Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Prospective Evaluation of Bulbar Function in Neuromuscular Patients', 'orgStudyIdInfo': {'id': '2013-A00601-44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neuromuscular patient', 'description': 'Patients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging', 'interventionNames': ['Procedure: tongue strength measurement', 'Procedure: respiratory function measurement', 'Procedure: swallowing tests', 'Other: Magnetic resonance imaging']}], 'interventions': [{'name': 'tongue strength measurement', 'type': 'PROCEDURE', 'description': 'tongue strength measurement', 'armGroupLabels': ['neuromuscular patient']}, {'name': 'respiratory function measurement', 'type': 'PROCEDURE', 'description': 'respiratory function measurement', 'armGroupLabels': ['neuromuscular patient']}, {'name': 'swallowing tests', 'type': 'PROCEDURE', 'description': 'swallowing tests', 'armGroupLabels': ['neuromuscular patient']}, {'name': 'Magnetic resonance imaging', 'type': 'OTHER', 'description': 'Magnetic resonance imaging', 'armGroupLabels': ['neuromuscular patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Orlikowski, MD, PhD', 'role': 'CONTACT', 'email': 'david.orlikowski@rpc.aphp.fr', 'phone': '33 1 47 10 77 77'}, {'name': 'Marjorie Figere, CRA', 'role': 'CONTACT', 'email': 'marjorie.figere@rpc.aphp.fr', 'phone': '33147104615'}, {'name': 'David Orlikowski, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Helene Prigent, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frederic Lofaso, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Home Ventilation Unit, Raymond Poincare Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '75015', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Orlikowski, PHD', 'role': 'CONTACT', 'email': 'david.orlikowski@rpc.aphp.fr', 'phone': '0033147107777'}, {'name': 'Brigitte Fauroux, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Non invasive ventilation Unit - Necker Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'David Orlikowski, MD PhD', 'role': 'CONTACT', 'email': 'david.orlikowski@rpc.aphp.fr', 'phone': '33147107777'}, {'name': 'Frederic Barbot, MD', 'role': 'CONTACT', 'email': 'frederic.barbot@rpc.aphp.fr', 'phone': '33147104474'}], 'overallOfficials': [{'name': 'David Orlikowski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique et Technologique 805"}, {'name': 'Helene Prigent, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique et Technologique 805"}, {'name': 'Frederic Lofaso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique et Technologique 805"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}