Normal Pressure HydrocephalusNCT00233701
Normal Pressure Hydrocephalus (NPH) Registry
An observational study of Normal Pressure Hydrocephalus, run by Codman & Shurtleff at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- How many people
- 343 participants
- Where
- 28 sitesUnited States
- Study dates
- Oct 2004to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Abington, Pennsylvania
Study site
Boise, Idaho
Study site
Boulder, Colorado
Study site
Camden, New Jersey
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Hershey, Pennsylvania, 17033
Study site
Iowa City, Iowa
Study site
Jacksonville, Florida
Study site
Johnson, Pennsylvania
Study site
Kingsport, Tennessee
Study site
La Crosse, Wisconsin
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Macon, Georgia
Study site
Medford, Oregon
Study site
Midwest City, Oklahoma
Study site
Payson, Utah
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Richmond, Virginia, 23298-0449
Study site
Salt Lake City, Utah
Study site
Wichita Falls, Texas
Study site
Winston-Salem, North Carolina
Study site
Youngstown, Ohio
About this study
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.
Read the 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
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- NPH, Hydrocephalus
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What is being measured
The primary outcome is the main question the study is designed to answer.
Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
Measured: End of trial
Secondary outcomes (1)
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)
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Association of Neurological Surgeons
- Investigators
- Anthony Marmarou, Ph.D., Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233701
- Sponsor's protocol ID
- NPH-US04-001
- Status last verified
- Oct 2008
- First submitted
- 4 Oct 2005
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Pressure Hydrocephalus (NPH) Registry
- ClinicalTrials.gov ID
- NCT00233701
- Acronym / sponsor ID
- NPH-US04-001
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- NPH, Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Collaborators
- American Association of Neurological Surgeons
- Study start
- Oct 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
Time frame: End of trial
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
- Related InfoLink provided by the sponsor.
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Marmarou, Ph.D. study chair
Virginia Commonwealth University
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus, run by Codman & Shurtleff at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment) (time frame: End of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2010.