Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-02 @ 9:43 PM
Study NCT ID:
NCT00600795
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2008-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Transforming Growth Factor-Beta 1 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': 'D003966', 'term': 'Camurati-Engelmann Syndrome'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'CSF'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2008-01-07', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TGF beta-1 levels', 'timeFrame': 'Time of Surgery'}, {'measure': 'Mini-mental status exam', 'timeFrame': 'Pre-operative, 3 and 12 months post-operatively'}, {'measure': 'Modified barthel index', 'timeFrame': 'Pre-operative, 3 and 12 months post-operatively'}, {'measure': 'Tinetti mobility assessment', 'timeFrame': 'Pre-operative, 3 and 12 months post-operatively'}], 'secondaryOutcomes': [{'measure': 'Programmable shunt setting', 'timeFrame': 'Pre-operative, 3 and 12 months post-operatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NPH', 'TGF-beta'], 'conditions': ['Normal Pressure Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus', 'detailedDescription': 'The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12\n\nThe specific aims of this research proposal are to:\n\n1. Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.\n2. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic and neurology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Normal Pressure Hydrocephalus\n\nExclusion Criteria:\n\n* Patients not diagnosed with Normal Pressure Hydrocephalus'}, 'identificationModule': {'nctId': 'NCT00600795', 'briefTitle': 'Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus', 'orgStudyIdInfo': {'id': '070875'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Patients diagnosed with Normal Pressure Hydrocephalus', 'interventionNames': ['Other: CSF collection']}], 'interventions': [{'name': 'CSF collection', 'type': 'OTHER', 'description': 'CSF collection at time of VPS insertion', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Noel Tulipan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}