Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT03562104
Status:
UNKNOWN
Last Update Posted:
2018-06-19
First Post:
2018-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swallowing Disorders in Minimally Consciousness Patients (MCS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Description of swallowing'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stages of swallowing disorders', 'timeFrame': 'Day 1', 'description': 'swallowing disorder stage is done using videofluoroscopy'}], 'secondaryOutcomes': [{'measure': 'Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder', 'timeFrame': 'Day 1', 'description': 'Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Disorder', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.', 'detailedDescription': 'After inclusion, the patients will underwent a videofluoroscopy and the Wessex Head Injury Matrix.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Legal representant signed\n* Aged between 18 and 70 years\n* Having a severe TBI (Glasgow \\< 8)\n* Without counterindication to underwent a VideoFluoroScopy\n* Could hold a setting position\n\nExclusion Criteria:\n\n* Pregnancy ongoing\n* Having a pathologic al examination of IX, X, XII cranial nerve examination\n* Massif faciale fracture\n* Psychiatric illness\n* Medical history of swallowing disorders'}, 'identificationModule': {'nctId': 'NCT03562104', 'acronym': 'TC-DEG', 'briefTitle': 'Swallowing Disorders in Minimally Consciousness Patients (MCS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients', 'orgStudyIdInfo': {'id': '2016/379 HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally consciousness Patient', 'description': 'Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient', 'interventionNames': ['Other: videofluoroscopy', 'Other: Wessex Head Injury Matrix scale']}], 'interventions': [{'name': 'videofluoroscopy', 'type': 'OTHER', 'description': 'Swallowing description in Minimally consciousness Patient', 'armGroupLabels': ['Minimally consciousness Patient']}, {'name': 'Wessex Head Injury Matrix scale', 'type': 'OTHER', 'description': 'Wessex Head Injury Matrix scale in Minimally consciousness Patient', 'armGroupLabels': ['Minimally consciousness Patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Centre les Herbiers', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'city': 'Rouen', 'country': 'France', 'facility': 'UH Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Eric VERIN, Pr', 'role': 'CONTACT', 'email': 'eric.verin@chu-rouen.fr', 'phone': '+3323288', 'phoneExt': '8265'}, {'name': 'Julien BLOT', 'role': 'CONTACT', 'email': 'julien.blot@chu-rouen.fr', 'phone': '+3323288', 'phoneExt': '8265'}], 'overallOfficials': [{'name': 'Eric VERIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}