Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Umeå University
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Neuropsychological outcome
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Feasibility(4.5 ± 1.5 months)
- Mini mental state Examination(4.5 ± 1.5 months)
- Baseline cognitive profile compared to healthy
Investigators
Anders Behrens
M.D., M.Sc.
Umeå University