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Study to Validate a Computerized Neuropsychological Test Battery

This study has been terminated.
(Insufficient subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Michael Williams, LifeBridge Health
ClinicalTrials.gov Identifier:
NCT01421446
First received: August 19, 2011
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Healthy Elderly

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Reliability and Validity of Umea Computerized Neuropsychological Battery

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2 [ Time Frame: Within 2-5 weeks of enrollment ] [ Designated as safety issue: No ]
  • Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2 [ Time Frame: Within 2-5 weeks of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421446

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

No publications provided

Responsible Party: Michael Williams, Medical Director, Sandra and Malcolm Berman Brain & Spine Institute, LifeBridge Health
ClinicalTrials.gov Identifier: NCT01421446     History of Changes
Other Study ID Numbers: BSI-LBH 1735
Study First Received: August 19, 2011
Last Updated: May 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by LifeBridge Health:
Neuropsychology

ClinicalTrials.gov processed this record on June 18, 2013