Study to Validate a Computerized Neuropsychological Test Battery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421446
Recruitment Status : Terminated (Insufficient subject recruitment)
First Posted : August 22, 2011
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Michael Williams, LifeBridge Health

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.

Condition or disease
Healthy Elderly

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.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Reliability and Validity of Umea Computerized Neuropsychological Battery
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Primary Outcome Measures :
  1. Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2 [ Time Frame: Within 2-5 weeks of enrollment ]
  2. Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2 [ Time Frame: Within 2-5 weeks of enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy elderly subjects without significant neurologic, psychiatric, cardiovascular, or other systemic disease that impairs neurologic function or cognitive function

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421446

United States, Maryland
Sandra and Malcolm Berman Brain & Spine Institute
Baltimore, Maryland, United States, 21209
Sponsors and Collaborators
LifeBridge Health
Principal Investigator: Michael A Williams, MD LifeBridge Health

Responsible Party: Michael Williams, Medical Director, Sandra and Malcolm Berman Brain & Spine Institute, LifeBridge Health Identifier: NCT01421446     History of Changes
Other Study ID Numbers: BSI-LBH 1735
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Michael Williams, LifeBridge Health: