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Completed

NCT Number: NCT00582127

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanders Brown Center for Aging, Neurology Dept.

Lexington, Kentucky, 40506, United States

About this study

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:

  • Patient tolerance
  • Ease of use
  • Data quality
  • Network architecture

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Signal to noise ratio (SNR) of ERPs

    Time frame: 9 months

Secondary outcomes

  1. Patient tolerance of the COGNISION(TM) system.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Neuronetrix, Inc.

Industry

Collaborators

  • University of Kentucky

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 28, 2007
Registry last updated
Dec 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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