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Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)

This study has been completed.
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01265251
First received: December 21, 2010
Last updated: December 22, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Normal Pressure Hydrocephalus
 Device: Computerized neuropsychological test
Other: Conventional neuropsychological test

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Validity [ Time Frame: Within 24 h ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 97
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Test-retest
Forty-four healthy elderly 60-82 years old
 Device: Computerized neuropsychological test
Computerized neuropsychological test battery.
Validity
Twenty six patients with various diseases and various ages
 Device: Computerized neuropsychological test
Computerized neuropsychological test battery.
Other: Conventional neuropsychological test
Conventional neuropsychological test (paper and pen)
Feasibility
Twenty seven patients under the preoperative investigation for INPH
 Device: Computerized neuropsychological test
Computerized neuropsychological test battery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265251

Locations
Sweden
Department of Clinical Neuroscience
Umeå, Västerbotten, Sweden, SE-901 85
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Anders Behrens, M.D., M.Sc. Department of Clinical Neuroscience
  More Information

No publications provided

Responsible Party: Anders Behrens M.D., Department of Clinical Neuroscience
ClinicalTrials.gov Identifier: NCT01265251     History of Changes
Other Study ID Numbers: 07-088M
Study First Received: December 21, 2010
Last Updated: December 22, 2010
Health Authority: Sweden: Institutional Review Board

Keywords provided by Umeå University:
Normal Pressure Hydrocephalus
Neuropsychological Test
Assessment of cognitive disorders/dementia
Neuropsychological assessment

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 22, 2013