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ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

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ClinicalTrials.gov Identifier: NCT00946127
Recruitment Status : Terminated (Unable to recruit patients and lack of efficacy in ETV arm)
First Posted : July 24, 2009
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Daniele Rigamonti, Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hydrocephalus Procedure: Ventriculoperitoneal Shunt Placement Procedure: Endoscopic Third Ventriculostomy(ETV)

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus
Study Start Date : March 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Shunt Arm
Ventriculoperitoneal Shunt
 Procedure: Ventriculoperitoneal Shunt Placement
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.
Other Names:
  • 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
ETV arm
Endoscopic Third Ventriculostomy
 Procedure: Endoscopic Third Ventriculostomy(ETV)
Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index. [ Time Frame: 1, 3, 6, 12 months after surgery ]
  2. Safety [ Time Frame: 0 through 12 months from Surgery ]
    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


Secondary Outcome Measures :
  1. Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis. [ Time Frame: 1 months, 3 months, 6 months and 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients with NPH
  • Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)
  • Ventriculomegaly defined by CT or MRI, Evans' index > 0.3
  • Clinical improvement after 3 day trial of CSF drainage.
  • MMSE>24
  • Informed consent from patient
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946127


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Daniele Rigamonti, MD, FACS Johns Hopkins University
More Information
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Publications:

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Responsible Party: Daniele Rigamonti, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00946127    
Other Study ID Numbers: NA_00014030
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by Daniele Rigamonti, Johns Hopkins University:
Normal Pressure Hydrocephalus
Communicating Hydrocephalus
Gait disorder
 Cognition
Shunt
Endoscopic Third Ventriculostomy.
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases