Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly

Healthy Elderly Clinical Trial

Official title:

Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188382
• Other study ID #: Hydrocephalus100
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: August 24, 2010
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

Objective. The intracranial pressure and cerebrospinal outflow resistance are essential parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the compliance of the system. The objective of this study was to determine the reference values in the elderly.

Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging apparatus. Subjects were eligible if they did not have any psychiatric or neurological disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow resistance were determined by a constant pressure infusion method with the patient in the supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 82 Years

Eligibility

Inclusion Criteria:

• Healthy

• 60-82 years

Exclusion Criteria:

• Psychiatric or neurological disorder or advanced atherosclerotic disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Elderly

Intervention

Procedure:
• CSF dynamic investigation

Locations

Country	Name	City	State
Sweden	Dep Clincial Neuroscience, Umeå university	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF outflow resistance			No
Secondary	Intracranial pressure			No

External Links

•   Web site of the Umeå hydrocephalus research group