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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01618500
Other study ID # 2011-47-31M
Secondary ID
Status Recruiting
Phase N/A
First received June 11, 2012
Last updated June 11, 2012
Start date January 2012
Est. completion date March 2013

Study information

Verified date June 2012
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Observational

Clinical Trial Summary

A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH) has been developed. The aim is to provide the clinician with a free of charge, standardized tool, assessing the cognitive decline or improvements in the cognitive domains specific for NPH. Results from the battery indicate good reliability and validity for the computerized tests

Results from the computerised battery seems promising. However, ability for the battery to detect cognitive improvements after a shunt operation remains to be tested.

Study objectives

1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting on neuropsychological performance in NPH patients, using a computerized battery.

2. Feasibility. The ability to complete the test battery by the intended patient group will be tested.

3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Older than 60 years of age

"Probable INPH" according to the NIH guidelines

Planned shunt surgery based on a diagnosis of INPH.

Exclusion Criteria:

- Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).

Patients not considered for shunt operation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Denmark Ålborg University Hospital Ålborg
Sweden Linköping University Hospital Linköping
Sweden Umeå University Umeå
Sweden Akademiska sjukhuset Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuropsychological outcome INPH patients, who are shunt candidates, will complete a computerized battery at two occasions: (1) hospital admission (Baseline) at most 1 month prior to surgery, and (2) 4.5 ± 1.5 months after shunt operation (Post-Shunt). 4.5 ± 1.5 months No
Secondary Mini mental state Examination INPH patients, who are shunt candidates, at each center will complete the Mini Mental State Examination at: (1) hospital admission (Baseline) at most 1 month prior to surgery, and (2) 4.5 ± 1.5 months after shunt operation (Post-Shunt). 4.5 ± 1.5 months No
Secondary Feasibility The number of patients who are able to complete individual subtests and the entire battery, will be monitored. 4.5 ± 1.5 months No
Secondary Baseline cognitive profile compared to healthy The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study). No
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