Study to Validate a Computerized Neuropsychological Test Battery

NCT ID: NCT01421446

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Healthy Elderly

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LifeBridge Health

OTHER

Sponsor Role: lead

Responsible Party

Michael Williams

Medical Director, Sandra and Malcolm Berman Brain & Spine Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Williams, MD

Role: PRINCIPAL_INVESTIGATOR

LifeBridge Health

Locations

Sandra and Malcolm Berman Brain & Spine Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

BSI-LBH 1735

Identifier Type: -

Identifier Source: org_study_id