Normal Pressure HydrocephalusNCT01265251
Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)
An observational study of Normal Pressure Hydrocephalus, run by Umeå University at 1 site in Sweden.
Trial summary
A computerised neuropsychological test battery to be used as a standardised tool assessing the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was developed. The aim of this study is to investigate the reliability, validity and feasibility of the battery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Computerized neuropsychological test and Conventional neuropsychological test
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2007to Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients
Who may be able to join
- Probable INPH under investigation
- Healthy elderly
- Various diseases
Who cannot join
- (Healthy elderly) medications affecting nervous system
- (Healthy elderly)heart disease
- (Healthy elderly)diabetes
- (Healthy elderly)disease of the nervous system
- (Healthy elderly)MMSE < 28
- (Healthy elderly)vascular risk factors (Two of: 1 hypertension, 2 smoking or 3 hyperlipidemia)
- (Healthy elderly)serious disease that may shorten life expectancy
- (Various diseases) Affected motor functions
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Neuroscience
Umeå, Västerbotten County, SE-901 85
About this study
Official title: Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)
A computerised neuropsychological test battery to be used as a standardised tool assessing the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was developed. The aim of this study is to investigate the reliability, validity and feasibility of the battery.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Computerized neuropsychological test, Conventional neuropsychological test
- 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.
Computerized neuropsychological testDevice
Computerized neuropsychological test battery.
Conventional neuropsychological testOther
Conventional neuropsychological test (paper and pen)
| Study group | Role | What they receive |
|---|---|---|
| Test-retest | Forty-four healthy elderly 60-82 years old Receives: Device: Computerized neuropsychological test | |
| Validity | Twenty six patients with various diseases and various ages Receives: Device: Computerized neuropsychological test; Other: Conventional neuropsychological test | |
| Feasibility | Twenty seven patients under the preoperative investigation for INPH Receives: Device: Computerized neuropsychological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
Computerized test battery and equivalent standard neuropsychological test battery is given to the same subject. Correlation between paper and pen and equivalent computerized test is calculated as a validity measure.
Measured: Within 24 h
Reliability
The computerized test battery is given to the same subject twice. Correlation between the two tests is calculated as a test-retest reliability measure.
Measured: More than 7 days, within 2 months
Feasibility
Patients under the investigation for INPH are given the computerized test battery. Number of patients who manage to complete the test is the feasibility measure.
Measured: Within 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startAug 2007
- Primary completionApr 2010
- Study completionApr 2010
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
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Investigators
- Anders Behrens, M.D., M.Sc., Principal investigator, Department of Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265251
- Sponsor's protocol ID
- 07-088M
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2010
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
PubMed 25279138
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)
- ClinicalTrials.gov ID
- NCT01265251
- Acronym / sponsor ID
- 07-088M
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Normal Pressure Hydrocephalus, Neuropsychological Test, Assessment of cognitive disorders/dementia, Neuropsychological assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Dec 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.
A computerised neuropsychological test battery to be used as a standardised tool assessing the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was developed. The aim of this study is to investigate the reliability, validity and feasibility of the battery.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test-retest | – | Device: Computerized neuropsychological testForty-four healthy elderly 60-82 years old |
| Validity | – | Device: Computerized neuropsychological test, Other: Conventional neuropsychological testTwenty six patients with various diseases and various ages |
| Feasibility | – | Device: Computerized neuropsychological testTwenty seven patients under the preoperative investigation for INPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients
Key inclusion criteria (3 listed)
- Probable INPH under investigation
- Healthy elderly
- Various diseases
Key exclusion criteria (8 listed)
- (Healthy elderly) medications affecting nervous system
- (Healthy elderly)heart disease
- (Healthy elderly)diabetes
- (Healthy elderly)disease of the nervous system
- (Healthy elderly)MMSE < 28
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 |
|---|---|---|
| Computerized neuropsychological testComputerized neuropsychological test battery. | Device | Feasibility, Test-retest, Validity |
| Conventional neuropsychological testConventional neuropsychological test (paper and pen) | Other | Validity |
Primary outcome
Validity
Time frame: Within 24 h
Computerized test battery and equivalent standard neuropsychological test battery is given to the same subject. Correlation between paper and pen and equivalent computerized test is calculated as a validity measure.
Reliability
Time frame: More than 7 days, within 2 months
The computerized test battery is given to the same subject twice. Correlation between the two tests is calculated as a test-retest reliability measure.
Feasibility
Time frame: Within 24 h
Patients under the investigation for INPH are given the computerized test battery. Number of patients who manage to complete the test is the feasibility measure.
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 23 Dec 2010.
- Derived from this study: PubMed 25279138Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
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.
Anders Behrens, M.D., M.Sc. principal investigator
Department of Clinical Neuroscience
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 Normal Pressure Hydrocephalus, 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 3 inclusion and 8 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 23 Dec 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?
Validity (time frame: Within 24 h). The study lists 3 primary outcomes in all. 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 NCT01265251, 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 23 Dec 2010.