Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus

• Conditions: Normal Pressure Hydrocephalus

• Registration Number: NCT01618500
• Lead Sponsor: Umeå University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-11
• Last Update Submitted: 2012-06-11
• Study First Posted: 2012-06-13
• Last Update Posted: 2012-06-13
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropsychological outcome	4.5 ± 1.5 months	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).

Secondary Outcome Measures

Name	Time	Method
Feasibility	4.5 ± 1.5 months	The number of patients who are able to complete individual subtests and the entire battery, will be monitored.
Mini mental state Examination	4.5 ± 1.5 months	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).
Baseline cognitive profile compared to healthy		The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).

Trial Locations

Locations (4)

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Ålborg University Hospital; 🇩🇰 Ålborg, Denmark

Umeå University; 🇸🇪 Umeå, Sweden

Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden