Relationship Between Vestibular Function and Topographic Memory

NCT ID: NCT01780896

Last Updated: 2013-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Elderly Population

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

70 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Michael Roman, PhD, LSSD

UNKNOWN

Sponsor Role collaborator

Ears of Texas, PA

UNKNOWN

Sponsor Role collaborator

Biomedical Development Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fred Previc, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Development Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ears of Texas, PA

San Antonio, Texas, United States

Site Status

Michael Roman, PhD, LSSP

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fred Previc, PhD

Role: CONTACT

210-308-0636

Karl McCloskey

Role: CONTACT

(361) 442-7491

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R43TR000645

Identifier Type: NIH

Identifier Source: secondary_id

View Link

121101-R43TR000645-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.