Normal Pressure Hydrocephalus Clinical Trial
Official title:
Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
Verified date | June 2012 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Institutional Review Board |
Study type | Observational |
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
1. 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.
2. Feasibility. The ability to complete the test battery by the intended patient group
will be tested.
3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of
healthy individuals (from previous study).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Ålborg University Hospital | Ålborg | |
Sweden | Linköping University Hospital | Linköping | |
Sweden | Umeå University | Umeå | |
Sweden | Akademiska sjukhuset | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Denmark, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Feasibility | The number of patients who are able to complete individual subtests and the entire battery, will be monitored. | 4.5 ± 1.5 months | No |
Secondary | Baseline cognitive profile compared to healthy | The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study). | No |
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