ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

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Brief Title

ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Official Title

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

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.
    

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


Primary Outcome

Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.

Secondary Outcome

 Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis.

Condition

Hydrocephalus

Intervention

Ventriculoperitoneal Shunt Placement

Study Arms / Comparison Groups

 Shunt Arm
Description:  Ventriculoperitoneal Shunt

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

13

Start Date

March 2009

Completion Date

October 2011

Primary Completion Date

October 2011

Eligibility 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
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniele Rigamonti, MD, FACS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00946127

Organization ID

NA_00014030


Responsible Party

Principal Investigator

Study Sponsor

Johns Hopkins University


Study Sponsor

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


Verification Date

October 2012