Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
Recruitment status was Recruiting
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.
- 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).
Normal Pressure Hydrocephalus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus|
- Neuropsychological outcome [ Time Frame: 4.5 ± 1.5 months ] [ Designated as safety issue: No ]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).
- Mini mental state Examination [ Time Frame: 4.5 ± 1.5 months ] [ Designated as safety issue: No ]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 [ Time Frame: 4.5 ± 1.5 months ] [ Designated as safety issue: No ]The number of patients who are able to complete individual subtests and the entire battery, will be monitored.
- Baseline cognitive profile compared to healthy [ Designated as safety issue: No ]The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Older than 60 years of age "Probable INPH" according to the NIH guidelines Planned shunt surgery based on a diagnosis of INPH.
Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).
Patients not considered for shunt operation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618500
|Ålborg University Hospital||Not yet recruiting|
|Ålborg, Denmark, 9100|
|Contact: Traberg Kristensen firstname.lastname@example.org|
|Linköping University Hospital||Not yet recruiting|
|Linköping, Sweden, 581 85|
|Contact: Leijon Goran.Leijon@lio.se|
|Umeå, Sweden, 901 85|
|Contact: Malm email@example.com|
|Akademiska sjukhuset||Not yet recruiting|
|Uppsala, Sweden, 751 85|
|Contact: Laurell firstname.lastname@example.org|