Clinical trial NCT00233701: Normal Pressure Hydrocephalus (NPH) Registry
Official title: Normal Pressure Hydrocephalus (NPH) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Pressure Hydrocephalus
Keywords: NPH
Hydrocephalus
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
Collaborators: name: American Association of Neurological Surgeons
First posted: 2005-10-06
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
timeFrame: End of trial
Secondary outcomes:
measure: 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)
timeFrame: End of trial
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Camden
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Youngstown
country: United States
state: Ohio
city: Midwest City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Johnson
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Payson
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: LaCrosse
country: United States
state: Wisconsin
Study officials:
affiliation: Virginia Commonwealth University
name: Anthony Marmarou, Ph.D.
role: STUDY_CHAIR
References: