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

Alzheimer's Disease Clinical Trial

Official title:

Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582127
• Other study ID #: VAL-UK-01
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: December 22, 2010
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Neuronetrix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
United States	Sanders Brown Center for Aging, Neurology Dept.	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Neuronetrix, Inc.	University of Kentucky

Country where clinical trial is conducted

United States, 

References & 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. Epub 2006 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal to noise ratio (SNR) of ERPs		9 months	No
Secondary	Patient tolerance of the COGNISION(TM) system.		9 months	No

External Links

•   Website for manufacturer of COGNISION(tm) System being tested