Relationship Between Vestibular Function and Topographic Memory

This study is not yet open for participant recruitment.
Verified January 2013 by Biomedical Development Corporation
Sponsor:
Collaborators:
Michael Roman, PhD, LSSD
Ears of Texas, PA
Information provided by (Responsible Party):
Biomedical Development Corporation
ClinicalTrials.gov Identifier:
NCT01780896
First received: January 29, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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
Normal Elderly Population

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Vestibular Function and Topographic Memory

Resource links provided by NLM:


Further study details as provided by Biomedical Development Corporation:

Primary Outcome Measures:
  • Determine relationship between topographic memory and vestibular function [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nominally healthy adults between the ages of 70 and 85 yrs who meet inclusion/exclusion criteria. All study participants will be recruited from the San Antonio community.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780896

Contacts
Contact: Fred Previc, PhD 210-308-0636 fprevic@sbcglobal.net
Contact: Karl McCloskey (361) 442-7491 mccloskey@biodevcorp.com

Locations
United States, Texas
Michael Roman, PhD, LSSP Not yet recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Michael Roman, MD         
Ears of Texas, PA Not yet recruiting
San Antonio, Texas, United States, 78215
Principal Investigator: Wesley Krueger, MD         
Sponsors and Collaborators
Biomedical Development Corporation
Michael Roman, PhD, LSSD
Ears of Texas, PA
Investigators
Principal Investigator: Fred Previc, PhD Biomedical Development Corporation
  More Information

No publications provided

Responsible Party: Biomedical Development Corporation
ClinicalTrials.gov Identifier: NCT01780896     History of Changes
Other Study ID Numbers: 121101-R43TR000645-01, R43TR000645
Study First Received: January 29, 2013
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biomedical Development Corporation:
Topographical Memory
Non-Topographical Memory
Vestibular Function
Alzheimer's Disease

ClinicalTrials.gov processed this record on April 16, 2014