NCT01618500

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. 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. 2.Feasibility. The ability to complete the test battery by the intended patient group will be tested.
  3. 3.Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy individuals (from previous study).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

June 11, 2012

Last Update Submit

June 11, 2012

Conditions

Normal Pressure Hydrocephalus

Keywords

Normal Pressure HydrocephalusNeuropsychological TestAssessment of cognitive disorders/dementiaNeuropsychological assessment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Mini mental state Examination

    4.5 ± 1.5 months

  • Feasibility

    4.5 ± 1.5 months

  • Baseline cognitive profile compared to healthy

Study Arms (1)

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 Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eighty INPH-patients. Consecutively included.

You may qualify if:

  • Older than 60 years of age
  • "Probable INPH" according to the NIH guidelines
  • Planned shunt surgery based on a diagnosis of INPH.

You may not qualify if:

  • Known cause for hydrocephalus (i.e., secondary NPH). Medical condition preventing cognitive testing (e.g. deafness, blindness).
  • Patients not considered for shunt operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ålborg University Hospital

Aalborg, 9100, Denmark

NOT YET RECRUITING

Linköping University Hospital

Linköping, 581 85, Sweden

NOT YET RECRUITING

Umeå University

Umeå, 901 85, Sweden

RECRUITING

Akademiska sjukhuset

Uppsala, 751 85, Sweden

NOT YET RECRUITING

Related Publications (1)

  • Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.

    PMID: 30738407DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal PressureDementia

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., M.Sc.

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

DK(1)SE(3)