Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-29 @ 2:35 AM
Study NCT ID:
NCT04045158
Status:
UNKNOWN
Last Update Posted:
2019-08-05
First Post:
2019-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Ultrasound in Neuromuscular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}], 'ancestors': [{'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diaphragm ultrasound motion', 'timeFrame': '1 year', 'description': 'using echography'}], 'secondaryOutcomes': [{'measure': 'correlation between diaphragm motion (mm) and forced vital capacity(ml)', 'timeFrame': '1 year', 'description': 'using echography and FPT'}, {'measure': 'correlation between diaphragm motion (mm) and inspiratory capacity (ml)', 'timeFrame': '1 year', 'description': 'using echography and FPT'}, {'measure': 'diaphragm thickness (mm)', 'timeFrame': '1 year', 'description': 'using echography'}, {'measure': 'correlation between diaphargm thickness and maximal inspiratory pressure (cmH20)', 'timeFrame': '1 year', 'description': 'using echography and FPT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diaphragm', 'ultrasound', 'echocardiography'], 'conditions': ['Muscular Dystrophies']}, 'referencesModule': {'references': [{'pmid': '34618930', 'type': 'DERIVED', 'citation': 'Fayssoil A, Nguyen LS, Stojkovic T, Prigent H, Carlier R, Amthor H, Bergounioux J, Zini J, Damez-Fontaine S, Wahbi K, Laforet P, Nicolas G, Behin A, Bassez G, Leturcq F, Ben Yaou R, Mansencal N, Annane D, Lofaso F, Orlikowski D. Determinants of diaphragm inspiratory motion, diaphragm thickening, and its performance for predicting respiratory restrictive pattern in Duchenne muscular dystrophy. Muscle Nerve. 2022 Jan;65(1):89-95. doi: 10.1002/mus.27432. Epub 2021 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.\n\nThe aims of the study are:\n\n* to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies\n* to assess the correlation between diaphragm ultrasound and FPT\n* to assess the correlation between diaphragm ultrasound and cardiac function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuromuscular diseases admitted for a cardio-respiratory function evaluation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Duchenne muscular dystrophy,\n* Becker muscular dystrophy,\n* LGMD,\n* myotonic dystrophy type 1 and type 2,\n* metabolic myopathy,\n* mitochondrial myopathy,\n* FSHD1 and 2,\n* myasthenia\n\nExclusion Criteria:\n\n* history of cardiac surgery\n* history of thoracic surgery\n* brain traumatism'}, 'identificationModule': {'nctId': 'NCT04045158', 'briefTitle': 'Diaphragm Ultrasound in Neuromuscular Disorders', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Diaphragm Ultrasound in Neuromuscular Disorders', 'orgStudyIdInfo': {'id': 'DIAPH-NMD'}}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Abdallah FAYSSOIL', 'investigatorAffiliation': "Centre d'Investigation Clinique et Technologique 805"}}}}