Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)

Normal Pressure Hydrocephalus Clinical Trial

Official title:

Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265251
• Other study ID #: 07-088M
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: December 22, 2010
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: December 2010
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Device:
• Computerized neuropsychological test
Computerized neuropsychological test battery.

Other:
• Conventional neuropsychological test
Conventional neuropsychological test (paper and pen)

Locations

Country	Name	City	State
Sweden	Department of Clinical Neuroscience	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No