Normal Pressure Hydrocephalus (NPH) Registry

February 5, 2010 updated by: Codman & Shurtleff
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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

343

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 States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Los Angeles, California, United States
    • Colorado
      • Boulder, Colorado, United States
    • Florida
      • Jacksonville, Florida, United States
    • Georgia
      • Macon, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Michigan
      • Detroit, Michigan, United States
    • New Jersey
      • Camden, New Jersey, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Youngstown, Ohio, United States
    • Oklahoma
      • Midwest City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Hershey, Pennsylvania, United States, 17033
      • Johnson, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Kingsport, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Wichita Falls, Texas, United States
    • Utah
      • Payson, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States, 23298-0449
    • Wisconsin
      • LaCrosse, Wisconsin, United States

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
Time Frame: End of trial
End of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
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
End of trial

Collaborators and Investigators

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

Sponsor

Codman & Shurtleff

Collaborators

American Association of Neurological Surgeons

Investigators

  • Study Chair: Anthony Marmarou, Ph.D., Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

October 1, 2004

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (ESTIMATE)

October 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 5, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPH-US04-001

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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