Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)

NCT ID: NCT00727142

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-07-31

Brief Summary

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This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

Detailed Description

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By comparing one group with active CSF shunting with another with non .

Conditions

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Normal Pressure Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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open shunt

functioning shunt

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

Insertion of a functioning shunt

closed shunt

NON FUNCTIONING SHUNT

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

Insertion of a functioning shunt

Interventions

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Surgical treatment

Insertion of a functioning shunt

Intervention Type PROCEDURE

Other Intervention Names

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Functioning shunt

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria

* Alzheimer disease
* Vascular dementia
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Hospitals

OTHER

Sponsor Role lead

Responsible Party

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A Toma

Consultant Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurence Watkins, FRCS

Role: PRINCIPAL_INVESTIGATOR

NHNN

Locations

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National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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08/0149

Identifier Type: -

Identifier Source: org_study_id

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