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Normal Pressure Hydrocephalus (NPH) Registry

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. Identifier: NCT00233701
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 8, 2010
American Association of Neurological Surgeons
Information provided by:
Codman & Shurtleff

Brief Summary:
The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual surgeons, as well as a national data repository for scientific inquiry and publications.

Condition or disease
Normal Pressure Hydrocephalus

Detailed Description:
This is a prospective, multi-center, observational database to collect data on the characteristics, management practices, and patient outcomes of NPH patients. It will be offered to a geographically representative group of U.S. physicians who will enroll NPH patients. The physician makes his/her own clinical decisions; thus, the data captured provides current practice patterns related to diagnosis, management, and results. The registry may also assist physicians in patient follow-up and certain practice management tasks. The data collected will serve to inform the medical community on optimal care for this patient population

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Study Type : Observational
Actual Enrollment : 343 participants
Time Perspective: Prospective
Official Title: Normal Pressure Hydrocephalus (NPH) Registry
Study Start Date : October 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Primary Outcome Measures :
  1. Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment) [ Time Frame: End of trial ]

Secondary Outcome Measures :
  1. To determine frequency of the various treatments for NPH and the outcomes of those treatment (assessed during surgery and at follow-up/no safety assessment) [ Time Frame: End of trial ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NPH patient who is a candidate for a shunt. Can not be under that age of 18, have a known contraindication for a shunt, or have an expected life span of less than 24 months.

Inclusion Criteria:

  • Patient meets the diagnosis criteria for Normal Pressure Hydrocephalus
  • Patient is a candidate for a hydrocephalus shunt system, per the discretion of the investigator
  • Patient or legal representative has signed an informed consent form. Competency to sign the consent form will be left up to the discretion of the investigator

Exclusion Criteria:

  • Patient is under the age of 18 years
  • Patient has a known contraindication for a shunt
  • Patient has an expected life span of less than 24 months
  • Patient has an unwillingness or inability to return for required follow-up visits

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 identifier (NCT number): NCT00233701

  Show 28 Study Locations
Sponsors and Collaborators
Codman & Shurtleff
American Association of Neurological Surgeons
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Study Chair: Anthony Marmarou, Ph.D. Virginia Commonwealth University

Additional Information:
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Responsible Party: Michael Ward, Worldwide Director, Clinical Research, Codman & Shurtleff Identifier: NCT00233701     History of Changes
Other Study ID Numbers: NPH-US04-001
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: October 2008
Keywords provided by Codman & Shurtleff:
Additional relevant MeSH terms:
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Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases