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

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00582127
• Lead Sponsor: Neuronetrix, Inc.

Brief 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.

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

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Study Start: 2008-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Signal to noise ratio (SNR) of ERPs	9 months

Secondary Outcome Measures

Name	Time	Method
Patient tolerance of the COGNISION(TM) system.	9 months

Trial Locations

Locations (1)

Sanders Brown Center for Aging, Neurology Dept.; 🇺🇸 Lexington, Kentucky, United States