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Improved Analysis Methods for Infusion Tests

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01319136
First Posted: March 21, 2011
Last Update Posted: March 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Umeå University
  Purpose
Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.

Condition
Idiopathic Normal Pressure Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Novel Infusion Method for Describing CSF Dynamics

Resource links provided by NLM:


Further study details as provided by Umeå University:

Enrollment: 48
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that had a preoperative investigation because of communicating hydrocephalus. MRI revealed ventriculomegaly (Evans ratio > 0.3), no obstruction to CSF flow at visual inspection. Most, but not all, fulfilled the criteria of "probable" or "possible" INPH.
Criteria

Inclusion Criteria:

  • preoperative investigation because of communicating hydrocephalus
  • ventriculomegaly (Evans ratio > 0.3)
  • no obstruction to CSF flow at visual inspection

Exclusion Criteria:

  • postoperative infusion test investigations
  • patients that were unable to understand instructions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319136


Locations
Sweden
Uppsala University Hospital
Uppsala, Uppland, Sweden, 751 85
Umeå University Hospital
Umeå, Västerbotten, Sweden, 901 85
Sponsors and Collaborators
Umeå University
Investigators
Study Director: Jan Malm, PhD, MD Department of Clinical Neuroscience
  More Information

Responsible Party: Kennet Andersson, MSc, Umeå University
ClinicalTrials.gov Identifier: NCT01319136     History of Changes
Other Study ID Numbers: Dnr 08-130M
First Submitted: March 18, 2011
First Posted: March 21, 2011
Last Update Posted: March 21, 2011
Last Verified: March 2009

Keywords provided by Umeå University:
new infusion test method
reference method
cerebrospinal fluid dynamics

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases