- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188382
Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Umeå, Sweden, 901 85
- Dep Clincial Neuroscience, Umeå university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy
- 60-82 years
Exclusion Criteria:
- Psychiatric or neurological disorder or advanced atherosclerotic disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy elderly
Healthy elderly 60-82 years; Normal MRI; No psychiatric or neurological disorder and without signs of advanced atherosclerotic disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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CSF outflow resistance
|
Secondary Outcome Measures
Outcome Measure |
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Intracranial pressure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan I Malm, PhD, MD, Umea University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Hydrocephalus100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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