Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT03092804
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2017-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognition assessments', 'timeFrame': 'Day 1 after shunting', 'description': 'The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)'}, {'measure': 'Cognition assessments', 'timeFrame': 'Day 90 after shunting', 'description': 'The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)'}, {'measure': 'Cognition assessments', 'timeFrame': 'one year after shunting', 'description': 'The neuropsychological battery assessment (including MMSE, MOCA as well as cognitive domains especially executive function examinations)'}, {'measure': 'Walking ability evaluation', 'timeFrame': 'Day 1 after shunting', 'description': 'Including 10m walking test, up and go tests'}, {'measure': 'Walking ability evaluation', 'timeFrame': 'Day 90 after shunting', 'description': 'Including 10m walking test, up and go tests'}, {'measure': 'Walking ability evaluation', 'timeFrame': 'one year after shunting', 'description': 'Including 10m walking test, up and go tests'}], 'primaryOutcomes': [{'measure': 'The brain constructure and neural network changing one day after shunting', 'timeFrame': 'Day 1 after shunting', 'description': '* Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume\n* Neural network( DMN)by the resting functional MRI'}, {'measure': 'The brain constructure and neural network changing 90 days after shunting', 'timeFrame': 'Day 90 after shunting', 'description': 'Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume\n\n•Neural network( DMN)by the resting functional MRI'}, {'measure': 'The brain constructure and neural network changing one year after shunting', 'timeFrame': 'one year after shunting', 'description': 'Using the voxel based morphology technique to measure the ventricular volume and brain lobe volume\n\n•Neural network( DMN)by the resting functional MRI'}], 'secondaryOutcomes': [{'measure': 'Assessment of the clinical syndrome of normal pressure hydrocephalus', 'timeFrame': 'Day 1 after shunting', 'description': 'iNPHGS'}, {'measure': 'Assessment of the clinical syndrome of normal pressure hydrocephalus', 'timeFrame': 'Day 90 after shunting', 'description': 'iNPHGS'}, {'measure': 'Assessment of the clinical syndrome of normal pressure hydrocephalus', 'timeFrame': 'one year after shunting', 'description': 'iNPHGS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Shunting', 'Brain constructure', 'Neural network'], 'conditions': ['Normal Pressure Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'With the advent of the aging society, dementia becomes the focus of common people. As for the neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia. Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking ability as well as brain construction imaging and neural network before and after ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the process, the supplementary test, for instance, CSF tap test, will be validated the predictive value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with physical and cognitive symptoms and brain image findings (Brain CT or MRI) suggestive of NPH were evaluated at neurological outpatient clinic of Peking Union Medical College Hospital according to the NPH diagnosis criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nncluded will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both.\n\n1. Are 50 years old or older\n2. Patients who understand the study protocol\n3. Patients who meet the criteria for NPH\n\n 1. A typical personal history\n 2. A typical brain imaging on head CT or MRI\n 3. Normal LP findings excluding other conditions\n 4. Exclusion of other conditions causing the symptomatology\n\nExclusion Criteria:\n\n1. Patients below the age of 50 years.\n2. Patients who underwent shunt surgery before'}, 'identificationModule': {'nctId': 'NCT03092804', 'briefTitle': 'The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients', 'orgStudyIdInfo': {'id': 'NeuroimagingNPH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal pressure hydrocephalus', 'description': 'Included will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both\n\nThe NPH patients will undergo the CSF tap test and then receive the ventriculo-peritoneal shunting surgery. They will have the examination of brain constructure neuroimaging and functional MRI prior to and posterior to the shunting.', 'interventionNames': ['Procedure: ventriculo-peritoneal shunting']}, {'label': 'normal control', 'description': 'Healthy volunteers will undergo the examination of brain constructure and functional MRI.'}], 'interventions': [{'name': 'ventriculo-peritoneal shunting', 'type': 'PROCEDURE', 'description': 'A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)', 'armGroupLabels': ['normal pressure hydrocephalus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caiyan Liu, MD', 'role': 'CONTACT', 'email': 'liucy-pumch@163.com', 'phone': '8613161202662'}, {'name': 'Liling Dong, MD', 'role': 'CONTACT', 'email': 'sophi_d@163.com', 'phone': '8613521801162'}, {'name': 'Jing Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Caiyan Liu, MD', 'role': 'CONTACT', 'email': 'liucy-pumch@163.com', 'phone': '8613161202662'}, {'name': 'Liling Dong, MD', 'role': 'CONTACT', 'email': 'sophi_d@163.com', 'phone': '8613521801162'}], 'overallOfficials': [{'name': 'Jing Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}