Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
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|ClinicalTrials.gov Identifier: NCT01618500|
Recruitment Status : Unknown
Verified June 2012 by Anders Behrens, Umeå University.
Recruitment status was: Recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
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).
|Condition or disease|
|Normal Pressure Hydrocephalus|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
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.
- Neuropsychological outcome [ Time Frame: 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).
- Mini mental state Examination [ Time Frame: 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 [ Time Frame: 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 healthyThe baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618500
|Ålborg University Hospital||Not yet recruiting|
|Ålborg, Denmark, 9100|
|Contact: Traberg Kristensen email@example.com|
|Linköping University Hospital||Not yet recruiting|
|Linköping, Sweden, 581 85|
|Contact: Leijon Goran.Leijon@lio.se|
|Umeå, Sweden, 901 85|
|Contact: Malm firstname.lastname@example.org|
|Akademiska sjukhuset||Not yet recruiting|
|Uppsala, Sweden, 751 85|
|Contact: Laurell email@example.com|