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

This study has been completed.
Sponsor:
Collaborator:
University of Kentucky
Information provided by:
Neuronetrix, Inc.
ClinicalTrials.gov Identifier:
NCT00582127
First received: December 19, 2007
Last updated: December 22, 2010
Last verified: December 2010
  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

Resource links provided by NLM:


Further study details as provided by Neuronetrix, Inc.:

Primary Outcome Measures:
  • Signal to noise ratio (SNR) of ERPs [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:

  1. Patient tolerance
  2. Ease of use
  3. Data quality
  4. 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
Study Population

Patients and family from the University of Kentucky Sanders Brown Center for Aging

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582127

Locations
United States, Kentucky
Sanders Brown Center for Aging, Neurology Dept.
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Neuronetrix, Inc.
University of Kentucky
Investigators
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 July 29, 2014