Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
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|ClinicalTrials.gov Identifier: NCT00582127|
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : December 24, 2010
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.
|Condition or disease|
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:
- Patient tolerance
- Ease of use
- Data quality
- Network architecture
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Mild-moderate Alzheimer's Disease
- Signal to noise ratio (SNR) of ERPs [ Time Frame: 9 months ]
- Patient tolerance of the COGNISION(TM) system. [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582127
|United States, Kentucky|
|Sanders Brown Center for Aging, Neurology Dept.|
|Lexington, Kentucky, United States, 40506|
|Principal Investigator:||Charles D Smith, M.D.||University of Kentucky|