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

This study is currently recruiting participants.
Verified June 2012 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Anders Behrens, Umeå University
ClinicalTrials.gov Identifier:
NCT01618500
First received: June 11, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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).

Condition
Normal Pressure Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Neuropsychological outcome [ Time Frame: 4.5 ± 1.5 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mini mental state Examination [ Time Frame: 4.5 ± 1.5 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of patients who are able to complete individual subtests and the entire battery, will be monitored.

  • Baseline cognitive profile compared to healthy [ Designated as safety issue: No ]
    The baseline cognitive profile of INPH-patients will be compared to healthy individuals (from previous study).


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
INPH-patients

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eighty INPH-patients. Consecutively included.

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618500

Locations
Denmark
Ålborg University Hospital Not yet recruiting
Ålborg, Denmark, 9100
Contact: Traberg Kristensen         btk@rn.dk    
Sweden
Linköping University Hospital Not yet recruiting
Linköping, Sweden, 581 85
Contact: Leijon         Goran.Leijon@lio.se    
Umeå University Recruiting
Umeå, Sweden, 901 85
Contact: Malm         jan.malm@neuro.umu.se    
Akademiska sjukhuset Not yet recruiting
Uppsala, Sweden, 751 85
Contact: Laurell         katarina.laurell@akademiska.se    
Sponsors and Collaborators
Umeå University
  More Information

No publications provided

Responsible Party: Anders Behrens, M.D., M.Sc., Umeå University
ClinicalTrials.gov Identifier: NCT01618500     History of Changes
Other Study ID Numbers: 2011-47-31M
Study First Received: June 11, 2012
Last Updated: June 11, 2012
Health Authority: Sweden: Institutional Review Board

Keywords provided by Umeå University:
Normal Pressure Hydrocephalus
Neuropsychological Test
Assessment of cognitive disorders/dementia
Neuropsychological assessment

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 19, 2013