Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 24, 2010
December 1, 2010
2.8 years
December 19, 2007
December 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Signal to noise ratio (SNR) of ERPs
9 months
Secondary Outcomes (1)
Patient tolerance of the COGNISION(TM) system.
9 months
Study Arms (2)
1
Mild-moderate Alzheimer's Disease
2
Age-matched Controls
Eligibility Criteria
Patients and family from the University of Kentucky Sanders Brown Center for Aging
You may qualify if:
- Age 60 to 85
- Mild to moderate diagnosis of Alzhiemer's disease
- Age 60 to 85
- Cognitively healthy with no complaints
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuronetrix, Inc.lead
- University of Kentuckycollaborator
Study Sites (1)
Sanders Brown Center for Aging, Neurology Dept.
Lexington, Kentucky, 40506, United States
Related Publications (1)
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.
PMID: 16989799BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles D Smith, M.D.
University of Kentucky
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 28, 2007
Study Start
January 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 24, 2010
Record last verified: 2010-12