Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-24 @ 5:09 AM
Study NCT ID:
NCT01909960
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2013-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow MRI in Normal Pressure Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057446', 'term': 'Hydrodynamics'}, {'id': 'D002560', 'term': 'Cerebrovascular Circulation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebrospinal fluid (CSF) stroke volume evolution other 6 months', 'timeFrame': 'Day 1 (baseline), Day 180', 'description': "Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution"}], 'secondaryOutcomes': [{'measure': 'Blood flow analysis : evolution other 6 months', 'timeFrame': 'Day 1 (baseline), Day 180', 'description': 'Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.'}, {'measure': "Larson's score evolution over 6 months", 'timeFrame': 'Day 1, Day 180', 'description': 'Record symptoms on walking, living conditions and urinary disorders'}, {'measure': 'Neuropsychological test evolution over 6 months', 'timeFrame': 'Day1, Day 180', 'description': 'Consists in mini mental status evaluation (MMSE) for cognitive evaluation'}, {'measure': 'Blood flow analysis : evolution other one year', 'timeFrame': 'Day 1 (baseline) and Day 365', 'description': 'Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.'}, {'measure': "Larson's score evolution over one year", 'timeFrame': 'Day 1 and Day 365', 'description': 'Record symptoms on walking, living conditions and urinary disorders'}, {'measure': 'Neuropsychological test evolution over one year', 'timeFrame': 'Day1, Day 365', 'description': 'Consists in mini mental status evaluation (MMSE) for cognitive evaluation'}, {'measure': 'cerebrospinal fluid (CSF) stroke volume evolution other one year', 'timeFrame': 'Day1 (baseline), Day 365', 'description': "Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal pressure hydrocephalus', 'Flow MRI', 'Dementia', 'Cerebrospinal fluid', 'Shunt'], 'conditions': ['Normal Pressure Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ventricular dilation seen on morphological magnetic resonance imaging (MRI)\n* Walking disorder\n* Cognitive disorder\n* Participants gave their written informed consent\n\nExclusion Criteria:\n\n* Contra-indication to MRI\n* Obstructive tumoral hydrocephalus\n* Curatorship or tutorship\n* Pregnancy or lactation\n* No social assurance'}, 'identificationModule': {'nctId': 'NCT01909960', 'acronym': 'HydroFlux', 'briefTitle': 'Flow MRI in Normal Pressure Hydrocephalus', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus', 'orgStudyIdInfo': {'id': 'PHRCIR11-DR-BALEDENT'}, 'secondaryIdInfos': [{'id': '2011-A01633-38', 'type': 'REGISTRY', 'domain': 'RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery', 'description': 'Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)', 'interventionNames': ['Other: Flow imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Clinical follow-up', 'description': 'Patients who will undergo flow imaging but not surgery (75% of the studied population)', 'interventionNames': ['Other: Flow imaging']}], 'interventions': [{'name': 'Flow imaging', 'type': 'OTHER', 'otherNames': ['Flow MRI', 'Cine phase-constrast magnetic resonance imaging', 'CSF pulsatility', 'Hydrodynamic', 'Cerebral blood flow'], 'description': "Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.\n\nClinical examination consists in Larson's score and MMSE", 'armGroupLabels': ['Clinical follow-up', 'Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Olivier Balédent, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}