Evaluation of Cognitive State Using Neurosteer EEG System
Evaluation of Cognitive State Using Neurosteer EEG System
This is an observational study. Patients who fulfill all inclusion criteria and none of the
 exclusion criteria will be enrolled in the study, be neurologically evaluated and will go
 through EEG recordings while listening to an auditory cognitive assessment tool and
 preforming tasks. EEG recordings will be analyzed using proprietary computational analyses.
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.