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

May 10, 2018 updated by: A Toma, University College London Hospitals

Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

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 Kingdom
      • London, United Kingdom, WC1N 3BG
        • National Hospital For Neurology and Neurosurgery

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

  • Alzheimer disease
  • Vascular dementia

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: open shunt
functioning shunt
Procedure: Surgical treatment
Insertion of a functioning shunt
Other Names:
  • Functioning shunt
ACTIVE_COMPARATOR: closed shunt
NON FUNCTIONING SHUNT
Procedure: Surgical treatment
Insertion of a functioning shunt
Other Names:
  • Functioning shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in walking speed
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
improved cognition or continence
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

University College London Hospitals

Investigators

  • Principal Investigator: Laurence Watkins, FRCS, NHNN

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

July 1, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (ESTIMATE)

August 1, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/0149

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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