Evaluation of Cognitive State Using Neurosteer EEG System

One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. An objective tool to asses the level of cognitive decline is therefore needed. Such a tool may be used to determine the level of cognitive decline independent of personal interpretation and/or variance between clinicians and provide consistency in assessment across patients and between medical facilities.

The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes.

In this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Patients (or legal guardian) will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform tasks. Level of cognition will be assessed by Neurosteer technology and statistical analysis will be performed to validate the results.

Inclusion criteria

• Men and women over the age of 45.
• MMSE score < 30.
• MMSE score ≥ 10.
• Patient is able to collaborate.
• No other cognitive comorbidity.
• No seizure event.

Exclusion criteria

• Advanced stage of cognitive decline (MMSE < 10).
• Any verbal or non-verbal form of objection from patient or form patient's family member or significant other.
• Presence of several cognitive comorbidity.
• Damage to integrity of scalp and/or skull.
• Skin irritation in the facial and forehead area.
• Significant hearing impairments.
• History of drug abuse.