Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Alzheimer's Disease |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Mild-moderate Alzheimer's Disease
|
|
2
Age-matched Controls
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients and family from the University of Kentucky Sanders Brown Center for Aging
Inclusion Criteria for AD:
- Age 60 to 85
- Mild to moderate diagnosis of Alzhiemer's disease
Inclusion Criteria for Control:
- 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
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Charles D. Smith, M.D., University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00582127 History of Changes |
| Other Study ID Numbers: | VAL-UK-01 |
| Study First Received: | December 19, 2007 |
| Last Updated: | December 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Neuronetrix, Inc.:
|
senile dementia |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013