Idiopathic Normal Pressure HydrocephalusNCT01319136
Improved Analysis Methods for Infusion Tests
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Umeå University at 2 sites in Sweden.
Trial summary
Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- How many people
- 48 participants
- Where
- 2 sitesSweden
- Study dates
- Mar 2009to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that had a preoperative investigation because of communicating hydrocephalus. MRI revealed ventriculomegaly (Evans ratio > 0.3), no obstruction to CSF flow at visual inspection. Most, but not all, fulfilled the criteria of "probable" or "possible" INPH.
Who may be able to join
- preoperative investigation because of communicating hydrocephalus
- ventriculomegaly (Evans ratio > 0.3)
- no obstruction to CSF flow at visual inspection
Who cannot join
- postoperative infusion test investigations
- patients that were unable to understand instructions
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Umeå University Hospital
Umeå, Västerbotten County, 901 85
Uppsala University Hospital
Uppsala, Uppland, 751 85
About this study
Official title: Novel Infusion Method for Describing CSF Dynamics
Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- new infusion test method, reference method, cerebrospinal fluid dynamics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Investigators
- Jan Malm, PhD, MD, Study director, Department of Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319136
- Sponsor's protocol ID
- Dnr 08-130M
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2011
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Infusion Method for Describing CSF Dynamics
- ClinicalTrials.gov ID
- NCT01319136
- Acronym / sponsor ID
- Dnr 08-130M
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- new infusion test method, reference method, cerebrospinal fluid dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Mar 2011 (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: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that had a preoperative investigation because of communicating hydrocephalus. MRI revealed ventriculomegaly (Evans ratio > 0.3), no obstruction to CSF flow at visual inspection. Most, but not all, fulfilled the criteria of "probable" or "possible" INPH.
Key inclusion criteria (3 listed)
- preoperative investigation because of communicating hydrocephalus
- ventriculomegaly (Evans ratio > 0.3)
- no obstruction to CSF flow at visual inspection
Key exclusion criteria (2 listed)
- postoperative infusion test investigations
- patients that were unable to understand instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Mar 2011.
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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 Malm, PhD, MD study director
Department of Clinical Neuroscience
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Umeå University at 2 sites 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 3 inclusion and 2 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 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Where can I read the original study information?
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 21 Mar 2011.