- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780896
Relationship Between Vestibular Function and Topographic Memory
January 30, 2013 updated by: Biomedical Development Corporation
The Relationship Between Vestibular Function and Topographic Memory
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78215
- Ears of Texas, PA
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San Antonio, Texas, United States, 78229
- Michael Roman, PhD, LSSP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Determine relationship between topographic memory and vestibular function
Time Frame: 14 days
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14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Fred Previc, PhD, Biomedical Development Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
January 29, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Estimate)
February 1, 2013
Last Update Submitted That Met QC Criteria
January 30, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 121101-R43TR000645-01
- R43TR000645 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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