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

Study Overview
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Brief Summary
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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).

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

Conditions
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Normal Pressure Hydrocephalus

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INPH-patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal Pressure Hydrocephalus, Neuropsychological Test, Assessment of cognitive disorders/dementia, Neuropsychological assessment