Normal Pressure Hydrocephalus (NPH) Registry

This study has been completed.
Sponsor:
Collaborator:
American Association of Neurological Surgeons
Information provided by:
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00233701
First received: October 4, 2005
Last updated: February 5, 2010
Last verified: October 2008
  Purpose

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 Phase
Normal Pressure Hydrocephalus
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Normal Pressure Hydrocephalus (NPH) Registry

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: October 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233701

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

Additional Information:
No publications provided

Responsible Party: Michael Ward, Worldwide Director, Clinical Research, Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00233701     History of Changes
Other Study ID Numbers: NPH-US04-001
Study First Received: October 4, 2005
Last Updated: February 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:
NPH
Hydrocephalus

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

ClinicalTrials.gov processed this record on April 16, 2014