- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01265251
Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)
December 22, 2010 updated by: Umeå University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
97
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Västerbotten
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Umeå, Västerbotten, Sweden, SE-901 85
- Department of Clinical Neuroscience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients
Description
Inclusion Criteria:
- Probable INPH under investigation
- Healthy elderly
- Various diseases
Exclusion Criteria:
- (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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Test-retest
Forty-four healthy elderly 60-82 years old
|
Computerized neuropsychological test battery.
|
|
Validity
Twenty six patients with various diseases and various ages
|
Computerized neuropsychological test battery.
Conventional neuropsychological test (paper and pen)
|
|
Feasibility
Twenty seven patients under the preoperative investigation for INPH
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Computerized neuropsychological test battery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 24 h
|
|
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.
|
More than 7 days, within 2 months
|
|
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.
|
Within 24 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anders Behrens, M.D., M.Sc., Department of Clinical Neuroscience
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
December 22, 2010
First Posted (Estimate)
December 23, 2010
Study Record Updates
Last Update Posted (Estimate)
December 23, 2010
Last Update Submitted That Met QC Criteria
December 22, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-088M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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