Relationship Between Vestibular Function and Topographic Memory

Sponsor
Biomedical Development Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01780896
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH), Michael Roman, PhD, LSSD (Other), Ears of Texas, PA (Other)
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Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. Topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations using such memories. Performance on each of these topographic memory tasks will be compared to performance on a set of comparable nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory are the first to show degenerative changes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Relationship Between Vestibular Function and Topographic Memory
    Study Start Date :
    Feb 1, 2013
    Anticipated Primary Completion Date :
    Apr 1, 2013
    Anticipated Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Study Group

    Outcome Measures

    Primary Outcome Measures

    1. Determine relationship between topographic memory and vestibular function [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Males or females of all racial and ethnic groups between the ages of 70 and 85 years of age;

    • Montreal Cognitive Assessment (MOCA) (http://www.mocatest.org) score of >24;

    • No known history or current evidence of stroke, trauma, psychiatric illness, or other insult to the brain;

    • No current use of psychoactive medicine other than caffeine (100 mg/day) or alcohol (1-2 drinks per night);

    • Normal sleep (at least an average of 7 hours for four days prior to participation);

    • Able and willing to comply with study requirements including following instructions to complete vestibular and neuropsychological testing; and

    • Have full understanding of all elements of provide signature and dating of the written informed consent prior to the initiation of procedures specified in protocol.

    Exclusion Criteria:
    • <70 or >85 yrs of age;

    • MOCA score of <25;

    • History, or current evidence, of stroke, trauma, psychiatric illness, or other insult to the brain;

    • Prior history of inner-ear balance problems;

    • Current use of psychoactive medicine other than moderate caffeine or alcohol use;

    • Acute or chronic sleep deprivation during the week prior to participation (<7 hours/night on average for four nights prior to participation).

    Other Restrictions:
    • No alcohol use on the night before the vestibular testing

    • 7 hours minimum sleep the night before vestibular testing

    • No eye make-up can be worn on the day of the vestibular test due to possible interference with vestibular-ocular reflex testing apparatus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ears of Texas, PA San Antonio Texas United States 78215
    2 Michael Roman, PhD, LSSP San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Biomedical Development Corporation
    • National Center for Advancing Translational Science (NCATS)
    • Michael Roman, PhD, LSSD
    • Ears of Texas, PA

    Investigators

    • Principal Investigator: Fred Previc, PhD, Biomedical Development Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biomedical Development Corporation
    ClinicalTrials.gov Identifier:
    NCT01780896
    Other Study ID Numbers:
    • 121101-R43TR000645-01
    • R43TR000645
    First Posted:
    Jan 31, 2013
    Last Update Posted:
    Feb 1, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Biomedical Development Corporation

    Study Results

    No Results Posted as of Feb 1, 2013