ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

October 1, 2012 updated by: Daniele Rigamonti, Johns Hopkins University

Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 3, 6, 12 months after surgery
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
0 through 12 months from Surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 months, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Daniele Rigamonti, MD, FACS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00014030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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