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

Sponsor

Umeå University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01618500

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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

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.
Feasibility. The ability to complete the test battery by the intended patient group will be tested.
Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).

Condition or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
INPH-patients 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ålborg University Hospital	Ålborg	Denmark	9100
2	Linköping University Hospital	Linköping	Sweden	581 85
3	Umeå University	Umeå	Sweden	901 85
4	Akademiska sjukhuset	Uppsala	Sweden	751 85