Evaluation of Cognitive State in Senior Subjects Using Neurosteer Single-channel EEG With an Interactive Assessment Tool
Conditions: Mild Cognitive Impairment
Sponsor: Neurosteer Ltd.

Evaluation of cognitive state in senior subjects using  
Neurosteer single-channel EEG with an interactive assessment tool 
 
 
 
 
 
 
 
Clinical Research Center 
Neurosteer Ltd. 
 
 
 
Protocol 
Version 3.0 
05:2021 
May 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 3.0 
May 2021 
Neurosteer PUBLIC  
Page 2 of 3 
Protocol Summary 
OBJECTIVE 
To evaluate the ability to differentiate between cognitive states 
in the senior population using a single-channel EEG with an 
interactive assessment tool. 
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 performing tasks. EEG recordings will be analyzed 
using proprietary computational analyses. 
STUDY 
POPULATION 
The study population is comprised of senior patients.  
SAMPLE SIZE 
CONSIDERATIONS 80 subjects 
INCLUSION 
CRITERIA 
1. Men and women over the age of 50. 
2. MMSE ≥ 24 
3. Patient is able to collaborate. 
4. No other cognitive comorbidities. 
5. No seizure events. 
 
 
 
 
 
EXCLUSION 
CRITERIA 
 
 
 
 
1. MMSE < 24 
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 subjects according to inclusion and exclusion 
criteria. 
Research staff will inform the patient on study's objective and 
design. Patients will sign the Informed Consent Form (ICF).  
Patients will be divided into groups according to their initial 
MMSE score (mild cognitive impairment MMSE 24-27 and 
healthy seniors MMSE 28-30). Research staff will set up an 
initial assessment session using the Neurosteer system. In 
this session the patient will listen to the auditory assessment 
battery and perform tasks. The patient will be re-examined in 
the same experimental setting over the next 7 days and at 
least 1 day later. Level of cognition will be assessed by 
Neurosteer technology. 

Version 3.0 
May 2021 
Neurosteer PUBLIC  
Page 3 of 3 
DATA TO 
CAPTURE 
The following data will be collected for the purposes of this 
study: 
Demographics: age, gender. 
Clinical data: official diagnosis, MMSE score, IADL 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 
twice, 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.