Clinical Trial: Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus

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

  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).

Detailed Summary:
Sponsor: Umeå University

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 healthy
    The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).


Original Secondary Outcome: Same as current

Information By: Umeå University

Dates:
Date Received: June 11, 2012
Date Started: January 2012
Date Completion: March 2013
Last Updated: June 11, 2012
Last Verified: June 2012