ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00727142
Recruitment Status : Terminated (observed benefit of treatment larger than expected)
First Posted : August 1, 2008
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
A Toma, University College London Hospitals

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

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Procedure: Surgical treatment Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

  • Alzheimer disease
  • Vascular dementia

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

Responsible Party: A Toma, Consultant Neurosurgeon, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00727142     History of Changes
Other Study ID Numbers: 08/0149
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by A Toma, University College London Hospitals:
NPH
Hydrocephalus
Shunt

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