TerminatedNot Applicable

ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Stopped: Unable to recruit patients and lack of efficacy in ETV arm

United States13 participantsStarted 2009-03

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Safety

Timeframe: 0 through 12 months from Surgery

Trial details

NCT IDNCT00946127

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-10

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