Evaluation of Cognitive State in Seniors Using Neurosteer Single-channel EEG With an Auditory Assessment Tool
Conditions: Cognitive Decline
Sponsor: Neurosteer Ltd.

Evaluation of cognitive state in seniors using  
Neurosteer single-channel EEG with an auditory assessment tool 
 
 
 
 
 
 
 
Clinical Research Center 
Neurosteer Ltd. 
 
 
 
Protocol 
Version 1.0 
04:2022 
March 2022 
 
 
 
 
 
 
 
 
 
 
 
 

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 auditory instructions and performing 
cognitive and functional tasks. EEG recordings will be analyzed 
using proprietary computational analyses. 
STUDY 
POPULATION 
The study population is comprised of senior patients. 
SAMPLE SIZE 
CONSIDERATIONS 
90 subjects 
INCLUSION 
CRITERIA 
1. Men and women over the age of 50. 
2. MMSE ≥ 10. 
3. Patient is able to collaborate. 
4. 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. Significant hearing impairments. 
4. Significant vision impairments. 
5. Damage to integrity of scalp and/or skull. 
6. Skin irritation in the facial and forehead area. 
7. Epilepsy or seasure activity. 
8. 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 or legal guardian/ family/ 
accompanying individuals on study's objective and design. Patients 
will sign the Informed Consent Form (ICF). 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 cognitive tasks. Over the next 7 days, clinical staff will set 
up another session using the Neurosteer system. In this session the 
patient will listen to auditory instructions and perform two PASS 
sub-tasks: a drug sorting task and a phone use task.
Level of cognition will be assessed by validated screening tools 
(MMSE and MoCA) and the Neurosteer technology. 
DATA TO 
CAPTURE 
The following data will be collected for the purposes of this study: 
Demographics: age, gender, year of education. 
Clinical data: official diagnosis, comorbidities, drugs, MMSE score, 
MoCA score, GDS score, CLOX score, PASS drug sorting and phone 
use sub-scores. 
Medical history: number of years with the disease, date of surgery.  
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 and MoCA scores will be taken from previous evaluations 
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 and MoCA scores, and reaction 
times in the tasks. Linear mixed models (LMM) will be calculated 
with group and task level as independent variables.