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

Primary Purpose

Normal Pressure Hydrocephalus

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgical treatment
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Pressure Hydrocephalus focused on measuring NPH, Hydrocephalus, Shunt

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

  • Alzheimer disease
  • Vascular dementia

Sites / Locations

  • National Hospital for Neurology and Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

open shunt

closed shunt

Arm Description

functioning shunt

NON FUNCTIONING SHUNT

Outcomes

Primary Outcome Measures

improvement in walking speed

Secondary Outcome Measures

improved cognition or continence

Full Information

First Posted
July 29, 2008
Last Updated
May 10, 2018
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00727142
Brief Title
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)
Official Title
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
observed benefit of treatment larger than expected
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College London Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.
Detailed Description
By comparing one group with active CSF shunting with another with non .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
NPH, Hydrocephalus, Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open shunt
Arm Type
Active Comparator
Arm Description
functioning shunt
Arm Title
closed shunt
Arm Type
Active Comparator
Arm Description
NON FUNCTIONING SHUNT
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Other Intervention Name(s)
Functioning shunt
Intervention Description
Insertion of a functioning shunt
Primary Outcome Measure Information:
Title
improvement in walking speed
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improved cognition or continence
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Normal pressure Hydrocephalus Exclusion Criteria: Alzheimer disease Vascular dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Watkins, FRCS
Organizational Affiliation
NHNN
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom

12. IPD Sharing Statement

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

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