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

This study has been terminated.
(observed benefit of treatment larger than expected)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727142
First Posted: August 1, 2008
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University College London Hospitals
  Purpose
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

Condition Intervention
Normal Pressure Hydrocephalus Procedure: Surgical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • improvement in walking speed [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • improved cognition or continence [ Time Frame: 3 months ]

Enrollment: 14
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open shunt
functioning shunt
Procedure: Surgical treatment
Insertion of a functioning shunt
Other Name: Functioning shunt
Active Comparator: closed shunt
NON FUNCTIONING SHUNT
Procedure: Surgical treatment
Insertion of a functioning shunt
Other Name: Functioning shunt

Detailed Description:
By comparing one group with active CSF shunting with another with non .
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

  • Alzheimer disease
  • Vascular dementia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727142


Locations
United Kingdom
National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Laurence Watkins, FRCS NHNN
  More Information

Responsible Party: Mr Laurence Watkins, National Hospital for Neurology and Neurosurgery/Queen Square
ClinicalTrials.gov Identifier: NCT00727142     History of Changes
Other Study ID Numbers: 08/0149
First Submitted: July 29, 2008
First Posted: August 1, 2008
Last Update Posted: August 9, 2011
Last Verified: July 2008

Keywords provided by University College London Hospitals:
NPH
Hydrocephalus
Shunt

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases