Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline
Conditions: Cognitive Decline
Sponsor: Neurosteer Ltd.

Evaluation of cognitive state using Neurosteer system  
in patients suffering from cognitive decline 
 
 
 
Clinical Research Center 
Neurosteer Ltd. 
 
 
 
Protocol 
Version 2.0 
01:2019 
January 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 2.0 
January 2020 
Neurosteer PUBLIC 
Page 2 of 3 
Protocol Summary 
OBJECTIVE 
To evaluate the tolerability of the Neurosteer system in elderly 
population and to demonstrate the ability of the system to 
differentiate between cognitive states in patients with cognitive 
decline. 
STUDY DESIGN 
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. 
STUDY 
POPULATION 
The study population is comprised of patients with cognitive decline. 
SAMPLE SIZE 
CONSIDERATIONS 
60 subjects, a pilot study 
INCLUSION 
CRITERIA 
1. Men and women over the age of 45. 
2. MMSE ≥ 10. 
3. MMSE < 30. 
4. Patient is able to collaborate. 
5. No other cognitive comorbidities. 
6. No seizure events. 
EXCLUSION 
CRITERIA 
 
 
 
 
 
1. Advanced stage of cognitive decline (MMSE < 10). 
2. Any verbal or non-verbal form of objection from patient or form 
patient’s family member or significant other. 
3. Presence of several cognitive comorbidities.  
4. Damage to integrity of scalp and/or skull. 
5. Skin irritation in the facial and forehead area. 
6. Significant hearing impairments. 
7. History of drug abuse. 
STUDY 
PROCEDURES 
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 inform the patient or legal guardian/ 
family/ accompanying individuals on study's objective and design. 
Patients will be divided into groups according to their initial MMSE 
score (mild cognitive impairment 24-27, mild dementia 19-23, and 
moderate dementia 10-18). Research staff will set up an initial 
assessment session using Neurosteer system. In this session the 
patient will listen to the auditory assessment battery and perform 
tasks. According to initial assessment and patient compliance, the 
patient will be re-examined in the same experimental setting over the 
following weeks. Level of cognition will be assessed by Neurosteer 
technology. 

 
Version 2.0 
January 2020 
Neurosteer PUBLIC 
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DATA TO 
CAPTURE 
The following data will be collected for the purposes of this study: 
Demographics: age, gender. 
Clinical data: official diagnosis, MMSE score, comorbidities, drugs.  
Medical history: number of years with the disease. 
Measurements of the research: electrophysiological data captured 
by Neurosteer system.  
TECHNICAL 
DESCRIPTION OF 
THE SYSTEM 
The system is composed of hardware and software modules that 
facilitate the capture and interpretation of electrophysiological data 
as well as enable viewing the processed data in real time and offline. 
An electrode patch is attached on the subject’s forehead to capture 
the electrophysiological signal. The signal is sent via low energy 
Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to 
the cloud where the data is stored on a HIPAA compliant server. 
Data analysis performed in the cloud transforms the 
electrophysiological signal into easily readable data of brain activity, 
which is accessible via any web interface. The brain activity features 
(BAFs), which comprise the main novelty of the method, are created 
using a variant of the wavelet packet analysis and the best basis 
algorithm. Statistical analysis will be performed on the data.  
STATISTICAL 
ANALYSIS PLAN 
MMSE scores will be taken from previous evaluation performed in 
the institute. Each patient will be evaluated using the continuous 
measurement by the Neurosteer system. 
Statistical analyses will include Pearson correlations between 
electrophysiological data and MMSE scores, and reaction times in 
the tasks.  
Linear mixed models (LMM) will be calculated with group and task 
level as independent variables.