Reference Values of Cerebrospinal Fluid Outflow Resistanc... | NCT01188382

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

NCT01188382

Sponsor

Umeå University

Status

Completed

Last Update Posted

Aug 25, 2010Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Healthy Elderly

Interventions

CSF dynamic investigation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 24, 2010

First Posted Date

Aug 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2010

Last Update Posted Date

Aug 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CSF dynamic investigation	Procedure		Healthy elderly

Measure	Description	Time Frame
CSF outflow resistance

Measure	Description	Time Frame
Intracranial pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
60-82 years

Exclusion Criteria:

Psychiatric or neurological disorder or advanced atherosclerotic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy elderly

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan I Malm, PhD, MD	Umeå University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep Clincial Neuroscience, Umeå university		Umeå		901 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30497143	Derived	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.

Type	Date	Date Unknown
Release	Nov 3, 2022
Reset	Sep 13, 2023