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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00582127

Enrollment

Registered

2007-12-28

Start date

2008-01-31

Completion date

2010-11-30

Last updated

2010-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

senile, dementia

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Signal to noise ratio (SNR) of ERPs	9 months

Secondary

Measure	Time frame
Patient tolerance of the COGNISION(TM) system.	9 months

Countries

United States

Outcome results