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
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, see Learn About Clinical Studies.

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
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014