NCT01319136

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
Last Updated

March 21, 2011

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

March 18, 2011

Last Update Submit

March 18, 2011

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

new infusion test methodreference methodcerebrospinal fluid dynamics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • postoperative infusion test investigations
  • patients that were unable to understand instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uppsala University Hospital

Uppsala, Uppland, 751 85, Sweden

Location

Umeå University Hospital

Umeå, Västerbotten County, 901 85, Sweden

Location

Study Officials

  • Jan Malm, PhD, MD

    Department of Clinical Neuroscience

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 21, 2011

Record last verified: 2009-03

Locations

SE(2)