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Improved Analysis Methods for Infusion Tests

This study has been completed.
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01319136
First received: March 18, 2011
Last updated: NA
Last verified: March 2009
History: No changes posted
  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:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kennet Andersson, MSc, Umeå University
ClinicalTrials.gov Identifier: NCT01319136     History of Changes
Other Study ID Numbers: Dnr 08-130M
Study First Received: March 18, 2011
Last Updated: March 18, 2011
Health Authority: Sweden: Regional Ethical Review Board

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
Intracranial Hypertension

ClinicalTrials.gov processed this record on June 17, 2013