Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Neuropsychological outcome
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 60 years of age
- •"Probable INPH" according to the NIH guidelines
- •Planned shunt surgery based on a diagnosis of INPH.
排除标准
- •Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).
- •Patients not considered for shunt operation.
结局指标
主要结局
Neuropsychological outcome
时间窗: 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).
次要结局
- Feasibility(4.5 ± 1.5 months)
- Mini mental state Examination(4.5 ± 1.5 months)
- Baseline cognitive profile compared to healthy