NCT01188382

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

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

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
Last Updated

August 25, 2010

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

August 17, 2010

Last Update Submit

August 24, 2010

Conditions

Keywords

Intracranial pressureresistanceCSF outflowelderlyreference value

Outcome Measures

Primary Outcomes (1)

  • CSF outflow resistance

Secondary Outcomes (1)

  • Intracranial pressure

Study Arms (1)

Healthy elderly

Healthy elderly 60-82 years; Normal MRI; No psychiatric or neurological disorder and without signs of advanced atherosclerotic disease

Procedure: CSF dynamic investigation

Interventions

Healthy elderly

Eligibility Criteria

Age60 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy elderly

You may qualify if:

  • Healthy
  • years

You may not qualify if:

  • Psychiatric or neurological disorder or advanced atherosclerotic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep Clincial Neuroscience, Umeå university

Umeå, 901 85, Sweden

Location

Related Publications (1)

  • Jacobsson J, Qvarlander S, Eklund A, Malm J. Comparison of the CSF dynamics between patients with idiopathic normal pressure hydrocephalus and healthy volunteers. J Neurosurg. 2018 Nov 16;131(4):1018-1023. doi: 10.3171/2018.5.JNS173170. Print 2019 Oct 1.

Related Links

Study Officials

  • Jan I Malm, PhD, MD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 25, 2010

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 25, 2010

Record last verified: 2010-06

Locations