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Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.

NCT ID: NCT00582127

Last Updated: 2010-12-24

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

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.

An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.

Detailed Description

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Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.

Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.

Four important features of the COGNISION(TM) will be investigated:

1. Patient tolerance
2. Ease of use
3. Data quality
4. Network architecture

Conditions

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Alzheimer's Disease

Keywords

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senile dementia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Mild-moderate Alzheimer's Disease

No interventions assigned to this group

2

Age-matched Controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 60 to 85
* Mild to moderate diagnosis of Alzhiemer's disease


* Age 60 to 85
* Cognitively healthy with no complaints

Exclusion Criteria

* Subjects with advanced AD and severe impairment (CDR \> 2, MMSE less than 15)
* Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
* Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
* Subjects with a current prescription for psychoactive pharmaceuticals
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kentucky

OTHER

Sponsor Role collaborator

Neuronetrix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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University of Kentucky

Principal Investigators

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Charles D Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Sanders Brown Center for Aging, Neurology Dept.

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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Polikar R, Topalis A, Green D, Kounios J, Clark CM. Comparative multiresolution wavelet analysis of ERP spectral bands using an ensemble of classifiers approach for early diagnosis of Alzheimer's disease. Comput Biol Med. 2007 Apr;37(4):542-58. doi: 10.1016/j.compbiomed.2006.08.012. Epub 2006 Sep 20.

Reference Type BACKGROUND
PMID: 16989799 (View on PubMed)

Related Links

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http://www.neuronetrix.com

Website for manufacturer of COGNISION(tm) System being tested

Other Identifiers

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VAL-UK-01

Identifier Type: -

Identifier Source: org_study_id