NCT01421446

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

August 19, 2011

Last Update Submit

March 30, 2015

Conditions

Healthy Elderly

Keywords

Neuropsychology

Outcome Measures

Primary Outcomes (2)

  • Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2

    Within 2-5 weeks of enrollment

  • Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2

    Within 2-5 weeks of enrollment

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy elderly subjects without significant neurologic, psychiatric, cardiovascular, or other systemic disease that impairs neurologic function or cognitive function

You may qualify if:

  • Age 60-80

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra and Malcolm Berman Brain & Spine Institute

Baltimore, Maryland, 21209, United States

Location

Study Officials

  • Michael A Williams, MD

    LifeBridge Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Sandra and Malcolm Berman Brain & Spine Institute

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

US(1)