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NCT01319136 Clinical Trial

Improved Analysis Methods for Infusion Tests

Idiopathic Normal Pressure Hydrocephalus Clinical Trial

Official title:
Novel Infusion Method for Describing CSF Dynamics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01319136
Other study ID # Dnr 08-130M
Secondary ID
Status Completed
Phase N/A
First received March 18, 2011
Last updated March 18, 2011
Start date March 2009
Est. completion date August 2010

Study information
Verified date March 2009
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Umeå University Hospital Umeå Västerbotten
Sweden Uppsala University Hospital Uppsala Uppland

Sponsors (1)
Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

See also
  Status Clinical Trial Phase
Completed NCT00221091 - Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus Phase 2
Completed NCT01570257 - A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus N/A
Recruiting NCT04998175 - Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH) N/A
Recruiting NCT06428734 - Clinical Outcome in Patients With INPH
Active, not recruiting NCT04795089 - Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
Active, not recruiting NCT02495610 - Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH N/A
Completed NCT01374048 - Intracranial Pressure Waves Via Lumbar Puncture N/A