NCT01265251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
Last Updated

December 23, 2010

Status Verified

December 1, 2010

Enrollment Period

2.7 years

First QC Date

December 21, 2010

Last Update Submit

December 22, 2010

Conditions

Keywords

Normal Pressure HydrocephalusNeuropsychological TestAssessment of cognitive disorders/dementiaNeuropsychological assessment

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Within 24 h

Study Arms (3)

Test-retest

Forty-four healthy elderly 60-82 years old

Device: Computerized neuropsychological test

Validity

Twenty six patients with various diseases and various ages

Device: Computerized neuropsychological testOther: Conventional neuropsychological test

Feasibility

Twenty seven patients under the preoperative investigation for INPH

Device: Computerized neuropsychological test

Interventions

Computerized neuropsychological test battery.

FeasibilityTest-retestValidity

Conventional neuropsychological test (paper and pen)

Validity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Probable INPH under investigation
  • Healthy elderly
  • Various diseases

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Neuroscience

Umeå, Västerbotten County, SE-901 85, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hydrocephalus, Normal PressureDementia

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Anders Behrens, M.D., M.Sc.

    Department of Clinical Neuroscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 23, 2010

Study Start

August 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 23, 2010

Record last verified: 2010-12

Locations