Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease|
- Signal to noise ratio (SNR) of ERPs [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Patient tolerance of the COGNISION(TM) system. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Mild-moderate Alzheimer's 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
Please refer to this study by its ClinicalTrials.gov identifier: 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|