Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System

Evaluation of Cognitive State in Senior Subjects Using Neurosteer Single-channel EEG With an Interactive Assessment Tool

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 Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Neurosteer Aurora system

Detailed Description

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. Therefore, the development of a reliable tool to assess brain neurodegeneration, associated with cognitive decline independent of personal interpretation and/or variance between clinicians and between medical facilities would be highly valuable. This tool would allow the healthcare team to make appropriate treatment decisions that could aid in neurodegenerative disease prevention.

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. Research staff will inform the patient 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 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel, 42420
    • Recruiting
    • Dorot - Netanya Geriatric Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of patients from the inpatient rehabilitation department at Dorot Geriatric Medical Center were recruited to this study.

Description

Inclusion Criteria:

• Men and women over the age of 50.
• MMSE ≥ 24.
• Patient is able to collaborate.
• No other cognitive comorbidity.
• No seizure events.

Exclusion Criteria:

• MMSE < 24.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients; Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)

Device: Neurosteer Aurora 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and the Neurosteer Technology.	Cognition level changes will be evaluated by the Mini Mental State Examination (MMSE) and by the Neurosteer system (single channel EEG recording during cognitive auditory tasks). Pearson correlation will be calculated using the mean activity of the EEG variables and each individual MMSE score.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the pilot study results.	In a previous pilot study on a similar population of 50 subjects, biomarkers A0 and ST4 were found to be significantly correlated with MMSE score.The aim of this study is to further validate these results.	1 year
Inter-patient variability between two consecutive measurement sessions.	One limitation in the pilot study was high variability among subjects. Therefore, the aim of this study is to evaluate within-patient variability. For this purpose, subjects in this study will undergo two consecutive assessments over a period of one week.	1 year
Differentiation between subjects who are at risk for cognitive decline and cognitively healthy subjects.	In the pilot study, biomarkers A0 and ST4 showed significant ability to differentiate between the group of seniors with cognitive decline and the group of cognitively healthy seniors. The aim of this study is to differentiate between subjects that are at risk for cognitive decline and the cognitively healthy subjects.	1 year

Collaborators and Investigators

• Sponsor: Neurosteer Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cognition; EEG; Neurology; Neurosteer
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 092020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes