Normal Pressure HydrocephalusNCT01618500
Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
An observational study of Normal Pressure Hydrocephalus, run by Umeå University at 4 sites in 2 countries.
Trial summary
A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2012to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty INPH-patients. Consecutively included.
Who may be able to join
- Older than 60 years of age
- "Probable INPH" according to the NIH guidelines
- Planned shunt surgery based on a diagnosis of INPH.
Who cannot join
- Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).
- Patients not considered for shunt operation.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Sweden3 sites, 3 recruiting
- Not yet recruiting
Linköping University Hospital
Linköping, 581 85
Leijon, Goran.Leijon@lio.se
- Recruiting
Umeå University
Umeå, 901 85
Malm, jan.malm@neuro.umu.se
- Not yet recruiting
Akademiska sjukhuset
Uppsala, 751 85
Laurell, katarina.laurell@akademiska.se
Denmark1 site, 1 recruiting
- Not yet recruiting
Ålborg University Hospital
Aalborg, 9100
Traberg Kristensen, btk@rn.dk
About this study
A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Results from the battery indicate good reliability and validity for the computerized tests
Results from the computerised battery seems promising. However, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested.
Read more
Study objectives
- Improvement after shunt. The aim of this study is to evaluate the effects of shunting on neuropsychological performance in NPH patients, using a computerized battery.
- Feasibility. The ability to complete the test battery by the intended patient group will be tested.
- Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal Pressure Hydrocephalus, Neuropsychological Test, Assessment of cognitive disorders/dementia, Neuropsychological assessment
- Medical subject headings
- Hydrocephalus, Normal Pressure, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| INPH-patients | Inclusion criteria Older than 60 years of age "Probable INPH" according to the NIH guidelines Planned shunt surgery based on a diagnosis of INPH. Exclusion criteria Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness). Patients not considered for shunt operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological outcome
INPH patients, who are shunt candidates, will complete a computerized battery at two occasions: (1) hospital admission (Baseline) at most 1 month prior to surgery, and (2) 4.5 ± 1.5 months after shunt operation (Post-Shunt).
Measured: 4.5 ± 1.5 months
Secondary outcomes (3)
Mini mental state Examination
INPH patients, who are shunt candidates, at each center will complete the Mini Mental State Examination at: (1) hospital admission (Baseline) at most 1 month prior to surgery, and (2) 4.5 ± 1.5 months after shunt operation (Post-Shunt).
Measured: 4.5 ± 1.5 months
Feasibility
The number of patients who are able to complete individual subtests and the entire battery, will be monitored.
Measured: 4.5 ± 1.5 months
Baseline cognitive profile compared to healthy
The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
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 Normal Pressure HydrocephalusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Behrens, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618500
- Sponsor's protocol ID
- 2011-47-31M
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.
PubMed 30738407
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT01618500
- Acronym / sponsor ID
- 2011-47-31M
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal Pressure Hydrocephalus, Neuropsychological Test, Assessment of cognitive disorders/dementia, Neuropsychological assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 13 Jun 2012 (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.
A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Results from the battery indicate good reliability and validity for the computerized tests
Results from the computerised battery seems promising. However, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested.
Study objectives
- Improvement after shunt. The aim of this study is to evaluate the effects of shunting on neuropsychological performance in NPH patients, using a computerized battery.
- Feasibility. The ability to complete the test battery by the intended patient group will be tested.
- Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INPH-patients | – | –Inclusion criteria Older than 60 years of age "Probable INPH" according to the NIH guidelines Planned shunt surgery based on a diagnosis of INPH. Exclusion criteria Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness). Patients not considered for shunt operation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty INPH-patients. Consecutively included.
Key inclusion criteria (3 listed)
- Older than 60 years of age
- "Probable INPH" according to the NIH guidelines
- Planned shunt surgery based on a diagnosis of INPH.
Key exclusion criteria (2 listed)
- Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).
- Patients not considered for shunt operation.
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
Neuropsychological outcome
Time frame: 4.5 ± 1.5 months
INPH patients, who are shunt candidates, will complete a computerized battery at two occasions: (1) hospital admission (Baseline) at most 1 month prior to surgery, and (2) 4.5 ± 1.5 months after shunt operation (Post-Shunt).
3 secondary outcomes
Mini mental state Examination
Time frame: 4.5 ± 1.5 months
Feasibility
Time frame: 4.5 ± 1.5 months
Baseline cognitive profile compared to healthy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Derived from this study: PubMed 30738407Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus, run by Umeå University at 4 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological outcome (time frame: 4.5 ± 1.5 months). 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 NCT01618500, 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 13 Jun 2012.