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

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01618500
• Other study ID #: 2011-47-31M
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 11, 2012
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2012
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Locations

Country	Name	City	State
Denmark	Ålborg University Hospital	Ålborg
Sweden	Linköping University Hospital	Linköping
Sweden	Umeå University	Umeå
Sweden	Akademiska sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

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