Normal Pressure Hydrocephalus (NPH) Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00233701

Enrollment

343

Registered

2005-10-06

Start date

2004-10-31

Completion date

2008-09-30

Last updated

2010-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

NPH, Hydrocephalus

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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)	End of trial

Countries

United States

Outcome results