Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-15 @ 6:27 AM
Study NCT ID:
NCT06428734
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome in Patients With INPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DTIALPS', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'Change of DTIALPS singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed.'}], 'secondaryOutcomes': [{'measure': 'Kiefer score', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'A score for iNPH severity; range 0-26; higher indicates higher severity.'}, {'measure': 'Mini mental state Examination', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'A score for cognitive ability; range 0-30; higher indicates higher severity.'}, {'measure': 'Gait evaluation', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': '10 meters walking test were evaluated of iNPH patients.'}, {'measure': 'modified Rankin scale', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'A score for functional neurological status ; range 0-5; higher indicates higher severity.'}, {'measure': 'Change in the resting state fMRI', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'Change of BOLD singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed.'}, {'measure': 'omic pattern of CSF in iNPH patients', 'timeFrame': 'Before surgery in lumbar CSF', 'description': 'Comparing the omic pattern differences in CSF between iNPH patients and normal age-matched normal volunteers by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed.'}, {'measure': 'omic pattern of CSF in iNPH patients', 'timeFrame': 'Change from Baseline at 6 months after VP shunt', 'description': 'Comparing the omic pattern differences in CSF of iNPH patients before surgery and after VP shunt by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrocephalus', 'Idiopathic Normal Pressure Hydrocephalus'], 'conditions': ['Hydrocephalus', 'Idiopathic Normal Pressure Hydrocephalus', 'CSF', 'Glympathic System', 'Omic']}, 'referencesModule': {'references': [{'pmid': '37010581', 'type': 'BACKGROUND', 'citation': 'Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3.'}, {'pmid': '37724800', 'type': 'BACKGROUND', 'citation': 'Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1.'}, {'pmid': '38014747', 'type': 'BACKGROUND', 'citation': 'Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.', 'detailedDescription': 'Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging.\n\nAt study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.\n\nOptionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who was diagnosed as idiopathic normal pressure hydrocephalus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who was diagnosed as idiopathic normal pressure hydrocephalus\n\nExclusion Criteria:\n\n* patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases'}, 'identificationModule': {'nctId': 'NCT06428734', 'briefTitle': 'Clinical Outcome in Patients With INPH', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Phenotypes, Biomarkers and Pathophysiology in INPH', 'orgStudyIdInfo': {'id': 'XWCOPINPH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hydrocephalus', 'description': 'high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS', 'interventionNames': ['Diagnostic Test: hydrocephalus group']}, {'label': 'Normal group', 'description': 'Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics', 'interventionNames': ['Other: normal group']}], 'interventions': [{'name': 'hydrocephalus group', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS', 'armGroupLabels': ['hydrocephalus']}, {'name': 'normal group', 'type': 'OTHER', 'description': 'Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS', 'armGroupLabels': ['Normal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Chenghua', 'role': 'CONTACT', 'email': 'yuanchenghua@ccmu.edu.cn'}, {'name': 'Jian Fengzeng', 'role': 'CONTACT', 'email': 'jianfengzeng@xwh.ccmu.edu.cn'}, {'name': 'xin qu, dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fengzeng Jian', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'fengzeng jian, md', 'role': 'CONTACT', 'email': 'jianfengzeng@xwh.ccmu.edu.cn', 'phone': '01083198899'}, {'name': 'xin qu, md', 'role': 'CONTACT', 'email': 'xinqu@xwhosp.org', 'phone': '01083198899'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}