Normal Pressure Hydrocephalus (NPH) Registry

Sponsor

Codman & Shurtleff (Industry)

Overall Status

Completed

CT.gov ID

NCT00233701

Collaborator

American Association of Neurological Surgeons (Other)

343

Enrollment

Locations

Duration (Months)

12.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus

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 Design

Study Type:

Observational

Actual Enrollment :

343 participants

Time Perspective:

Prospective

Official Title:

Normal Pressure Hydrocephalus (NPH) Registry

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

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

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) [End of trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Phoenix	Arizona	United States
2	Los Angeles	California	United States
3	Boulder	Colorado	United States
4	Jacksonville	Florida	United States
5	Macon	Georgia	United States
6	Boise	Idaho	United States
7	Chicago	Illinois	United States
8	Iowa City	Iowa	United States
9	Lexington	Kentucky	United States
10	Detroit	Michigan	United States
11	Camden	New Jersey	United States
12	Charlotte	North Carolina	United States
13	Winston-Salem	North Carolina	United States
14	Youngstown	Ohio	United States
15	Midwest City	Oklahoma	United States
16	Medford	Oregon	United States
17	Portland	Oregon	United States
18	Abington	Pennsylvania	United States
19	Hershey	Pennsylvania	United States	17033
20	Johnson	Pennsylvania	United States
21	Pittsburgh	Pennsylvania	United States
22	Kingsport	Tennessee	United States
23	Dallas	Texas	United States
24	Wichita Falls	Texas	United States
25	Payson	Utah	United States
26	Salt Lake City	Utah	United States
27	Richmond	Virginia	United States	23298-0449
28	LaCrosse	Wisconsin	United States