Healthy ElderlyNCT01188382
Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
An observational study of Healthy Elderly, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 60 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly
- What is being tested?
- CSF dynamic investigation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy elderly
Who may be able to join
- Healthy
- 60-82 years
Who cannot join
- Psychiatric or neurological disorder or advanced atherosclerotic disease
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Healthy Elderly
- Being tested
- CSF dynamic investigation
- Keywords
- Intracranial pressure, resistance, CSF outflow, elderly, reference value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF dynamic investigationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy elderly | Healthy elderly 60-82 years; Normal MRI; No psychiatric or neurological disorder and without signs of advanced atherosclerotic disease Receives: Procedure: CSF dynamic investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF outflow resistance
Secondary outcomes (1)
Intracranial pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ElderlyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Investigators
- Jan I Malm, PhD, MD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188382
- Sponsor's protocol ID
- Hydrocephalus100
- Status last verified
- Jun 2010
- First submitted
- 17 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30497143
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly
- ClinicalTrials.gov ID
- NCT01188382
- Acronym / sponsor ID
- Hydrocephalus100
- Conditions
- Healthy Elderly
- Keywords
- Intracranial pressure, resistance, CSF outflow, elderly, reference value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy elderly | – | Procedure: CSF dynamic investigationHealthy elderly 60-82 years; Normal MRI; No psychiatric or neurological disorder and without signs of advanced atherosclerotic disease |
Who may qualify
- Ages
- 60 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy elderly
Key inclusion criteria (2 listed)
- Healthy
- 60-82 years
Key exclusion criteria (1 listed)
- Psychiatric or neurological disorder or advanced atherosclerotic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF dynamic investigation | Procedure or surgery | Healthy elderly |
Primary outcome
CSF outflow resistance
1 secondary outcome
Intracranial pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Derived from this study: PubMed 30497143Jacobsson 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.
- Web site of the Umeå hydrocephalus research groupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan I Malm, PhD, MD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Elderly, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF outflow resistance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2010.