Study to Validate a Computerized Neuropsychological Test Battery

Healthy Elderly Clinical Trial

Official title:

Reliability and Validity of Umea Computerized Neuropsychological Battery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01421446
• Other study ID #: BSI-LBH 1735
• Status: Terminated
• Phase: N/A
• First received: August 19, 2011
• Last updated: March 30, 2015
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: LifeBridge Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent.

Description:

Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.

Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.

A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 60-80

Exclusion Criteria:

• Neurological disorder that results in motor or cognitive dysfunction

• Perceptual or motor difficulties that would prevent subjects from taking the assessment

• MMSE score <20

• MoCA score <26

• MAS score >9

• Significant abnormal neurologic examination findings

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy Elderly

Locations

Country	Name	City	State
United States	Sandra and Malcolm Berman Brain & Spine Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
LifeBridge Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2		Within 2-5 weeks of enrollment	No
Primary	Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2		Within 2-5 weeks of enrollment	No