Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-14 @ 5:24 AM
Study NCT ID:
NCT00946127
Status:
TERMINATED
Last Update Posted:
2012-10-03
First Post:
2009-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017287', 'term': 'Ventriculoperitoneal Shunt'}, {'id': 'D014696', 'term': 'Ventriculostomy'}], 'ancestors': [{'id': 'D002557', 'term': 'Cerebrospinal Fluid Shunts'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Unable to recruit patients and lack of efficacy in ETV arm', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-01', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.', 'timeFrame': '1, 3, 6, 12 months after surgery'}, {'measure': 'Safety', 'timeFrame': '0 through 12 months from Surgery', 'description': 'Incidence of operative complications related to insertion of a shunt or performing ETV Intra-operative hemorrhage Post Operative amnesia Post Operative hemorrhage Infections Others Incidence of complications related to either of the two procedure over long term follow-up Infection Shunt malfunction ETV closure Others'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis.', 'timeFrame': '1 months, 3 months, 6 months and 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal Pressure Hydrocephalus', 'Communicating Hydrocephalus', 'Gait disorder', 'Cognition', 'Shunt', 'Endoscopic Third Ventriculostomy.'], 'conditions': ['Hydrocephalus']}, 'referencesModule': {'references': [{'pmid': '15214981', 'type': 'BACKGROUND', 'citation': 'Gangemi M, Maiuri F, Buonamassa S, Colella G, de Divitiis E. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus. Neurosurgery. 2004 Jul;55(1):129-34; discussion 134. doi: 10.1227/01.neu.0000126938.12817.dc.'}, {'pmid': '18728569', 'type': 'BACKGROUND', 'citation': 'Gangemi M, Maiuri F, Naddeo M, Godano U, Mascari C, Broggi G, Ferroli P. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus: an Italian multicenter study. Neurosurgery. 2008 Jul;63(1):62-7; discussion 67-9. doi: 10.1227/01.NEU.0000335071.37943.40.'}, {'pmid': '18356257', 'type': 'BACKGROUND', 'citation': 'Pujari S, Kharkar S, Metellus P, Shuck J, Williams MA, Rigamonti D. Normal pressure hydrocephalus: long-term outcome after shunt surgery. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1282-6. doi: 10.1136/jnnp.2007.123620. Epub 2008 Mar 20.'}, {'pmid': '18054606', 'type': 'BACKGROUND', 'citation': 'Dusick JR, McArthur DL, Bergsneider M. Success and complication rates of endoscopic third ventriculostomy for adult hydrocephalus: a series of 108 patients. Surg Neurol. 2008 Jan;69(1):5-15. doi: 10.1016/j.surneu.2007.08.024.'}, {'pmid': '15674750', 'type': 'BACKGROUND', 'citation': 'Longatti PL, Fiorindi A, Martinuzzi A. Failure of endoscopic third ventriculostomy in the treatment of idiopathic normal pressure hydrocephalus. Minim Invasive Neurosurg. 2004 Dec;47(6):342-5. doi: 10.1055/s-2004-830128.'}, {'pmid': '16239882', 'type': 'BACKGROUND', 'citation': 'McGirt MJ, Woodworth G, Coon AL, Thomas G, Williams MA, Rigamonti D. Diagnosis, treatment, and analysis of long-term outcomes in idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Oct;57(4):699-705; discussion 699-705. doi: 10.1093/neurosurgery/57.4.699.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.', 'detailedDescription': 'Normal pressure Hydrocephalus is a reversible disorder of cognition and gait disorder.Currently the shunting of CSF is the recommended treatment of these patients. Even though shunts are known to be beneficial treatment of Hydrocephalus they often need treatment or revision for infection or malfunction. Endoscopic Third Ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.Few studies have also shown that it may be efficacious treatment Normal pressure Hydrocephalus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suspected of Normal pressure hydrocephalus i.e. - with gait disturbances and/ or cognitive disturbances and/or urinary incontinence with dilation of ventricles on CT or MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with NPH\n* Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)\n* Ventriculomegaly defined by CT or MRI, Evans' index \\> 0.3\n* Clinical improvement after 3 day trial of CSF drainage.\n* MMSE\\>24\n* Informed consent from patient"}, 'identificationModule': {'nctId': 'NCT00946127', 'briefTitle': 'ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus', 'orgStudyIdInfo': {'id': 'NA_00014030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Shunt Arm', 'description': 'Ventriculoperitoneal Shunt', 'interventionNames': ['Procedure: Ventriculoperitoneal Shunt Placement']}, {'label': 'ETV arm', 'description': 'Endoscopic Third Ventriculostomy', 'interventionNames': ['Procedure: Endoscopic Third Ventriculostomy(ETV)']}], 'interventions': [{'name': 'Ventriculoperitoneal Shunt Placement', 'type': 'PROCEDURE', 'otherNames': ['Hydrocephalus Shunt Component - Catheter-manufacturer- Medtronic Neurosurgery Inc', 'Codman and Hakim Shunt System--manufacturer-Codman & Shurtleff, Inc.', 'Medtronic PS Polyurethane Shunt--manufacturer-Medtronic Neurosurgery Inc', 'Miethke proGAV shunt system-manufacturer- Aesculap Inc', 'Medtronic PS Strata Medical Valve--manufacturer-Medtronic Neurosurgery Inc'], 'description': 'In the subjects who choose this arm, at the start of study- CSF (Cerebrospinal fluid ) will be shunted to peritoneum by placing a ventriculoperitoneal shunt catheter with or without shunt valves or anti-siphon device.', 'armGroupLabels': ['Shunt Arm']}, {'name': 'Endoscopic Third Ventriculostomy(ETV)', 'type': 'PROCEDURE', 'description': 'Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.', 'armGroupLabels': ['ETV arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Daniele Rigamonti, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniele Rigamonti', 'investigatorAffiliation': 'Johns Hopkins University'}}}}