Normal Pressure Hydrocephalus (NPH) Registry

Completed

• Conditions: Normal Pressure Hydrocephalus

• Registration Number: NCT00233701
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-06
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2010-02-05
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	End of trial