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

Neuronetrix

Status: Completed

Conditions: Alzheimer's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00582127

VAL-UK-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

50 participants in 2 patient groups

1

Description:

Mild-moderate Alzheimer's Disease

2

Description:

Age-matched Controls